Effect of Intradialysis Virtual Reality Exercise in Hemodinamic Stability: Randomized Trial

doi:10.21203/rs.3.rs-4802775/v1

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Effect of Intradialysis Virtual Reality Exercise in Hemodinamic Stability: Randomized Trial

https://doi.org/10.21203/rs.3.rs-4802775/v1

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Background:

Intradialysis exercise is recommended during the first two hours of the session to avoid hemodynamic instability, but this recommendation is a barrier for the implementation of exercise during dialysis. The main aim of this study was to evaluate the impact of intradialysis exercise in the last two hours versus the first two hours of the HD session on hemodynamic variables.

Methods

This is a randomized trial. Participants were randomized into two groups. Group A exercised within the first two hours of HD and Group B exercised within the last two hours of HD. The exercise consisted of playing a non-immersive virtual reality video game. The hemodynamic control variables (Systolic blood pressure SBP, diastolic blood pressure DBP and heart rate HR), the number of hypotension events, hypertensive crisis, and cardiac arrhythmias were recorded during the HD sessions. Other variables such as dialysis dose and molecule rebound were also recorded. A mixed linear regression model was used to analyze the results.

Results

40 patients completed the study. The SBP, DBP, and HR were compared between groups in different moments (Rest vs Exercise time) and no significant differences were shown. During the intervention period, Group A presented 16 hypotensive events, 10 hypertensive events and 1 arrhythmia event in 725 exercise sessions, while Group B presented 20 hypotensive events, 5 hypertensive events and 1 arrhythmia in 713 exercise sessions. There were no significant differences between groups. Antihypertensive drugs prescribed decreased significantly after the exercise program with similar control of SBP and HR.

Conclusion

The results showed that an intradialytic VR exercise during the last two hours of the HD session did not result in hemodynamic instability.

Health sciences/Nephrology

Physical sciences/Materials science

Hemodialysis

Exercise

Virtual reality

Hemodynamic stability

Chronic kidney disease (CKD) is a growing public health problem[1] affecting 15–20% of the adult population worldwide [2], and in advanced stages requires renal replacement therapy [3]. Hemodialysis (HD) is the most common treatment. It has been estimated that in 2010, two million patients received dialysis treatment worldwide and that in 2030 these numbers will double [4]. People in HD present with high comorbidities, a tendency to malnutrition, and a sedentary lifestyle with gradual deterioration of health-related quality of life (HRQoL) [5] which can trigger physical disability, emotional and social problems, and limitations in basic activities of daily living [6].

Exercise during HD improves physical function, HRQoL, cardiovascular risk factors, functional capacity, and emotional state, and may even decrease the demand for medical care [7] [8].

Intradialysis exercise has better adherence than exercise outside the dialysis unit. Rehabilitation based on virtual reality (VR) techniques is affordable and more accessible than other interventions[9] and VR intradialysis exercise is beneficial[10] [11]

Traditionally, it has been recommended to exercise intradialysis during the first two hours of the session to avoid hemodynamic instability, which limits clinical applicability[12] [13]. Limited studies have explored the possibility of doing exercise during the last hours of the dialysis session. Our team has demonstrated that performing an intradialysis exercise with VR at the end of a single HD session was not associated with hemodynamic instability. In addition, a decrease in events of hypotension was observed during HD sessions with exercise vs rest sessions [14]. A recent study concluded that there were no differences in intradialytic hypotension events when conventional exercise was performed at the beginning vs the end of the HD session [15].

During HD treatment, is sought the best dialytic adequacy. An adequate dose has been linked to better control of anemia [16], nutritional condition [17], control of hypertension, and survival on dialysis [18].

The heterogeneous distribution of cardiac output and water differentiates a high-flow system (kidneys, heart, brain, portal system, lungs, and blood) and another low-flow system (muscles, bones, skin, and fat) [19]. Due to the relationship between reduced blood flow and urea content, the rate of urea transfer from muscle tissues to the blood is low. Because of the delay in transfer, urea sequestration takes place at the level of the muscle compartment[20] [21]. At the end of the session, the dialysis technique is stopped, but the transfer of solutes from the muscle compartment to the blood persists; consequently, there is a sharp increase in urea and other molecules sequestered in the blood, this process is called the rebound effect [19].

Several studies focused on the effect of intradialysis exercise on dialytic adequacy [7],[22][23] and some concluded that intradialysis exercise favored the elimination of urea and creatinine in patients undergoing HD treatment [23], [24], as well as improved Kt/V [24]. Our group studied the effect of exercise in the first two hours of dialysis and rebound, noting that there were no significant differences in the change in dialysis dose Kt/V or the rebound of several molecules.[25] [26]

The main aim of this study was to evaluate the impact of intradialysis exercise in the last two hours versus the first two hours of the HD session on hemodynamic variables. The secondary aim was to evaluate the effect of intradialysis exercise on chronic blood pressure control, dialysis dose, molecules rebound, and nutritional status.

- Design

This was a randomized trial submitted in 06/08/2021 (NCT04046042). The participants were randomized into two groups by the nephrologist of the HD Unit: Group A exercised within the first two hours of HD and Group B exercised within the last two hours of the HD session. The study was carried out in the HD Unit of Hospital de Manises (Spain). Patient recruitment was open from September 2019 with follow-up until April 2023. The inclusion criteria were being on chronic HD treatment for 3 months or more, remaining clinically stable, and providing informed consent. The exclusion criteria were having suffered from myocardial infarction in the 6 weeks running up to the study, unstable angina, amputation of lower limbs above the knee with no prosthesis, cerebral vascular disease like stroke or transitory ischemia, musculoskeletal or respiratory alterations that worsen with effort or unable to perform functional physical tests.

- Intervention

The intervention with the intradialysis VR exercise program was implemented by the HD unit staff and supervised by a physiotherapist. The intradialysis exercise session was implemented for at least 6 months and started with a 5-minute warm-up, followed by the VR exercise session, depending on each patient’s fitness level. Group A and B exercised at different times as described above. To develop the VR exercise program, we used the adapted version of the Treasure Hunt game, a non-immersive VR system designed with a game format [11] [27]. In Treasure Hunt, the player must play by raising a lower limb and alternating the movement of both limbs across the screen. The difficulty level was adapted to the participants’ results. The hardware we used was a standard personal computer and monitor screen and Ms Kinect®, a movement-detection camera. At the beginning of the session, Treasure Hunt allows the therapist to define the VR session by selecting the number of exercise sub-sessions and their duration, as well as the sub-session rest periods, that were kept at 1 minute. The game difficulty was adaptive, and so the system automatically increased or decreased the level of difficulty depending on each person’s results. Once the program was finished, a 5-minute cool-down including stretching was performed. The intensity was registered through the rate of perception scale (RPE) and the session was adapted so that participants reported a rate of perceived exertion (RPE) between 12 and 15 (6 to 20 RPE scale). If the session was too easy (6–11) or too hard (16–20), the physiotherapist re-adjusted the number of sub-sessions and/or their duration, with a maximum of 6 sub-sessions, lasting 6 minutes for each sub-session. Adherence was defined as the percentage of sessions the participant performed from the total number of sessions offered.

- Measurements

Descriptive variables were recorded from the electronic medical record of each patient.

The hemodynamic control variables were Systolic blood pressure (SBP), Diastolic blood pressure (DBP), and Heart rate (HR). These variables were recorded every 30 minutes during all the HD sessions. These variables were compared in two ways. The first comparison was, in each HD session, variables recorded during the Rest time vs the Exercise time. The second comparison assessed the differences between the hemodynamic control variables (SBP, DBP and HR) during the Exercise time for Group A vs B.

The events of hypotension, hypertensive crisis, and cardiac arrhythmias were recorded during the HD sessions and are shown as the total number of events divided by the total number of HD sessions. Intradialysis hypotension was considered according to the KDOQI criteria: (SBP pre-HD – minimum intraHD SBP) ≥ 20mmHg and symptoms attributable to hypotension, and according to the Fall20Nadir90 criteria [30] (SBP preHD – SBP minimum intradialytic SBP) ≥ 20 mmHg and minimum intradialytic SBP < 90 mmHg. Hypertensive crises were considered for men SBP greater than 210 mmHg and 190 mmHg for women [28]. Clinically arrhythmia was defined as any of ventricular tachycardia > 130 beats/min lasting for ≥ 30 seconds, bradycardia of < 40 beats/min sustained for > 6 seconds, asystole for > 3 seconds, or patient-reported symptomatic events that were validated as being associated with clinically relevant arrhythmia by a serious event committee [29]. Events were recorded in two moments Baseline (events in the month before the start of the program) and Exercise (events during the exercise sessions). We studied in whole sample differences for events in Baseline vs Exercise and differences in Group A vs B for events during Exercise time.

In addition, chronic blood pressure control and antihypertensive drugs prescribed were studied in all patients who exercised for 6 months or more. Two moments were compared: Baseline (month before the start of the program) vs Final (last month of the exercise program). SBP, DBP, HR and mean arterial pressure (MAP) were determined before all HD sessions. MAP was calculated with the formula MAP = [SBP + 2 (DBP)] / 3 [33].

Dialysis dose and molecule rebound were calculated in one HD session (second weekly session out of three) without exercise (Rest) and in another session with intradialysis Exercise in consecutive weeks.

The dialysis dose was measured by second-generation KtV Daugirdas:

Kt/V Daug = - ln ((C2/C1) - (0.008*T)) + (4–3.5 * (C2/C1)) * UF/P

(C1: pre-dialysis Blood Urea in mg/dL; C2: post-dialysis Blood Urea in mg/dL; T: Session duration time in minutes UF: volume of removed ultrafiltrate in liters; P: post-dialysis weight of a subject in kilogram)

Urea, creatinine, potassium, and phosphorus rebound was calculated by the formula (34): Rebound (%) = 100 x (CR-C2) / C2

(C2: blood sample taken at the end of session; CR: blood sample taken 30 min after the session ended)

The nutrition and metabolism variables were recorded in two moments, Baseline (starting month of the program) Final (last month of the exercise program). The recorded variables were serum albumin, serum hemoglobin, serum potassium, serum phosphorus, serum calcium, serum ferritin, serum bicarbonate, serum triglycerides, serum LDL cholesterol and serum HDL cholesterol. We compared these results in two groups, control and exercise groups. The control group included participants who participated for less than 3 months in the clinical trial and dropped out voluntarily (patients who dropped out due to an incident pathology were excluded from the control group). The measures were taken at least 6 months from the start of the exercise program. The exercise group included participants in the clinical trial who exercised for, at least, 9 months.

- Statistical analysis

The sample size was estimated using the GRANMO sample size calculator, Version 8.0 April 2012 of the Program of the Girona Heart Registry (REGICOR), IMIM, Barcelona https://www.datarus.eu/en/applications/granmo/

Accepting an alpha risk of 0.05 and a power of 0.8 in a two-sided test 30 subjects are necessary in the first group and 30 in the second group to recognize statistically significant a difference greater than or equal to 10 mmHg in SBP. The common standard deviation is assumed to be 18 mmHg and the correlation coefficient between the initial and the final measurement is assumed to be 0.8. A drop-out rate of 30% has been anticipated. The expected results have been based on results obtained in previous studies[11] [14].

Data are presented as mean, standard deviation for continuous variables, and relative and absolute frequencies for categorical variables.

The analysis of the hemodynamic control measures (SBP, DBP and HR) was done using a mixed linear regression model that compares differences depending on the moment of the exercise during the session (Group A vs. Group B). Differences between the hemodynamic control variables (SBP, DBP and HR) during the Exercise time for Group A vs B were compared with a linear regression.

Events of hypotension, hypertensive crisis, and cardiac arrhythmias in Baseline vs Exercise for the whole sample were compared with the mixed linear regression. Differences in Group A vs B for events during Exercise time were compared with the linear regression.

Chronic blood pressure control and antihypertensive drugs prescribed (baseline vs final) were studied in all patients and compared with mixed linear regression.

Analysis of dialysis dose, nutrition, lipid metabolism, anemia, and bone mineral disease were compared baseline vs final in the control and exercise group with a mixed regression analysis.

Values of P < 0.05 were considered statistically significant. All analyses were performed using R software (version 4.2.2).

62 patients were included, 20 patients dropped out, and 40 patients completed the study (Fig. 1). The characteristics of the patients who remained in the study are shown in Table 1. The etiology of renal failure was diabetic nephropathy (32.5%), vascular kidney disease (22.5%), glomerulonephritis (5%), other kidney disease (17.5%) and unknown (22.5%).

Table 1

Patient characteristics
Variable	GROUP A N = 21	GROUP B N = 19
Gender (Female)	7 (33.3)	7 (36.8)
Age (Years)	73.86 (12.44)	69.74 (13.39)
Time in HD (Months)	42.57 (57.37)	50.32 (50.20)
Vascular Access (AVF)	18 (85.7)	13 (68.4)
Charlson Index (Points)	6.86 (2.10)	7.26 (2.92)
Diabetes Mellitus (Yes)	11 (52.4)	10 (52.6)
Legend: The data are shown as mean and standard deviation (SD) or N (%)
AVF Arteriovenous fistula

The recorded variables for hemodynamic control (SBP, DBP, HR) were compared in Group A and Group B at different moments (Rest vs Exercise time) and no significant differences were shown. No significant differences in hemodynamic control during exercise in Group A vs Group B were found (analysis results in Supplementary Table 1S, 2S, 3S, 4S and 5S). The mean of SBP, DBP and HR during the first two hours of HD session vs. the last two hours are shown in Table 2.

Table 2

Hemodynamic control 1-2h vs 3-4h
	GROUP A N = 21		GROUP B N = 19
Variable	1-2h (Exercise)	3-4h (Rest)	1-2h (Rest)	3-4h (Exercise)
SBP (mmHg)	136.79 (10.97)	138.36 (13.65)	138.01 (16.13)	139.95 (19.86)
DBP (mmHg)	63.82 (9.49)	64.33 (9.94)	64.76 (12.13)	68.23 (14.95)
HR (beats/min)	68.28 (9.49)	67.75 (9.53)	67.86 (8.22)	69.15 (7.16)
Legend: The data are shown as mean and standard deviation (SD). Analysis performed with mixed linear regression.

Events of hypotension, hypertension and arrhythmias were recorded at Baseline and Exercise time for the whole sample. No differences between Baseline and Exercise time were found in the number of recorded events (analysis results shown in Supplementary Material Table 6S). During the intervention period, Group A presented 16 hypotensive events, 10 hypertensive events and 1 arrhythmia event in 725 exercise sessions, while Group B presented 20 hypotensive events, 5 hypertensive events and 1 arrhythmia in 713 exercise sessions. There were no significant differences between the events in Group A vs B during the intervention period (analysis results shown in Supplementary Material Table 7S).

Antihypertensive drugs prescribed decreased significantly after the exercise program − 0.36 (95% CI: [-0.67, -0.05]; p = 0.03), with similar control of SBP and HR. Only DBP and MAP presented a significant increase, without significant differences in the hypertension classification categories according to 2020 International Society of Hypertension Global Hypertension Practice Guidelines [35] (Table 3).

Table 3

Antihypertensive drugs prescribed and blood pressure control.
Variable N = 40	Baseline	Final
Antihypertensive drugs	2.08 (1.36)	1.72 (1.32) *
SBP (mmHg)	138.30 (15.81)	139.89 (15.82)
DBP (mmHg)	62.90 (11.77)	65.94 (11.55)
HR (beats per minute)	68.66 (8.09)	69.10 (8.17)
MAP (mmHg)	88.03 (11.36)	90.59 (11.32)
The data are shown as mean and standard deviation (SD)
* p = 0.03

The results of dialysis dose and post-dialysis rebound are shown in Table 8S (Supplementary material). No significant differences were found in dialysis dose and post-dialysis rebound between Exercise and Rest in any of the groups. This measure was not taken in all participants since they were not willing to wait 30 minutes after the end of the dialysis session.

The results of the effect of exercise on nutrition, lipid metabolism, anemia and mineral bone disease are shown in Table 4. The control group included 24 patients (9 women), mean age 63 (19.8) years, vintage HD 48.7 (35.7) months and Charson Index 7.3 (3.1) points. The intervention group included 27 patients (8 women), mean age 73 (11.0) years, vintage HD 53.7 (59.7) months and Charson Index 7.7 (2.5) points.

Table 4

Effect of exercise on lipid metabolism, anemia, and bone mineral disease.
	INTERVENTION GROUP N = 27		CONTROL GROUP N = 24
	Baseline	Final	Baseline	Final	P- valor
Albumin (g/dL)	3.83 (0.38)	3.68 (0.37)	3.86 (0.35)	3.75 (0.43)	NS
Hemoglobin (g/dL)	11.53 (1.15)	11.52 (1.44)	11.13 (1.30)	11.34 (1.18)	NS
Potassium (mmol/L)	5.20 (0.66)	5.11 (0.58)	5.15 (1.40)	5.32 (1.40)	NS
Phosphorus (mg/dL)	4.32 (1.29)	4.03 (0.82)	4.69 (1.54)	4.25 (1.43)	NS
Calcium (mg/dL)	8.82 (0.44)	8.86 (0.46)	8.94 (0.66)	8.99 (0.81)	NS
Ferritin (ng/mL)	565.17 (286.92)	668.07 (434.54)	513.74 (339.31)	565.70 (288.82)	NS
Bicarbonate (mmol/L)	23.76 (3.09)	22.40 (2.69)	22.07 (3.62)	22.64 (2.61)	NS
TG (mg/dL)	132.65 (58.19)	131.62 (63.11)	176.25 (108.83)	169.71 (115.38)	NS
LDL (mg/dL)	55.51 (22.14)	59.29 (29.85)	66.10 (25.12)	66.02 (27.97)	NS
HDL (mg/dL)	40.2 (10.03)	43 (10.50)	42.89 (12.69)	40.61 (13.36)	0.0155*
Legend: HDL: High density lipoprotein; LDL: Low-Density Lipoprotein; TG: triglycerides. The data are shown as mean and standard deviation (SD)

This study shows that participating in VR exercise during the last two hours of the HD sessions is safe since there were no significant differences regarding hemodynamic instability between the group exercising during the first two hours versus the last two hours. This is clinically relevant because it broadens the time window in which HD healthcare unit staff can encourage patients to exercise.

Most of the studies have recommended intradialysis exercise during the first two hours of dialysis to avoid hemodynamic intolerance, but it is not so common to analyze the impact of intradialysis exercise at the end of the session and, to our knowledge, none of the published studies have analyzed the impact of VR exercise during the last two hours of HD on hemodynamic instability. Most of the published studies implemented aerobic exercise or combined aerobic and strength training during the first two hours of HD due to the hypothetical concern that exercise can cause hemodynamic instability[10][11][12][13][15] [30]. However, there is not much data supporting this theory, and following these recommendations results in time constraints. Only one recent study showed similar results to our study, showing that intradialytic cycling exercise during the last two hours of the HD session did not impact negatively on intradialytic hypotension [15].

Our study showed that there was a significant decrease in the antihypertension drugs after the exercise program (Table 3). This agrees with a previous study from our group where intradialysis VR exercise program was cost-effective. The main decreased cost was for the consumption of laboratory tests, outpatient visits, and radiology tests in the 12 months after the implementation of the exercise program [8]. Another study found that implementing an aerobic exercise program for 6 months led to a 36% reduction in the use of antihypertensive drugs and resulted in an annual cost saving of $885/patient-year [31].

It is known that exercise improves blood pressure and cardiovascular function in the general population[32][33] [34]. which might explain why during our study there was a significant reduction in hypertensive drug intake.

In our study, the consumption of antihypertensive drugs was reduced without changes in blood pressure figures. Thus, despite we did not find significant changes in blood pressure figures, we could conclude that the program had a positive impact on chronic blood pressure since the treatment was reduced and participants showed acceptable BP control.

We did not find any significant changes in SBP, DBP, and HR from baseline to the last month of exercise (Table 3). A recent study implemented a 6-months aerobic exercise training program and did not show a significant impact on the chronic BP of people in HD[35]. Another study found that exercise applied at any time during the HD session did not have a significant impact on the BP [15]. In the general population, it seems that exercise helps to stimulate the production of nitric oxide, which is a compound that helps dilate blood vessels, resulting in lower BP, and also helps reduce body weight and body fat, which also contribute to lower BP [32].

Regarding dialysis dose, these results agree with a previous study that implemented a 3-months intradialysis exercise program, suggesting that there is not a significant effect on the dialysis dose Kt/V or in the rebound urea [25]. It seems that during the rest period after exercising the retention of molecules in the muscular compartment could occur again.

Finally, a significant increase in HDL was observed in the exercise group (exercise ≥ 9 months) compared with the control group (patients that did not adhere to exercise, exercise < 3 months) (Table 4). These results align with a previous publication that reported a significant increase in HDL following a 12-week aerobic exercise program [36]. The increase in HDL levels has been associated with improved renal function in the general population and people with CKD. In previous studies, patients who demonstrated a remarkable increase in HDL levels through exercise intervention also showed an increase in glomerular filtration rate, suggesting a positive association between HDL and renal function in the general population and patients with CKD [36].

The primary limitation of the study is its small sample size. High dropout rates are common in long-term studies due to the elevated mortality and morbidity within this population. Additionally, the nutrition and metabolism variables were compared between two non-randomized groups: those who adhered to exercise and those who participated in the clinical trial for less than three months. Future studies should employ a randomized design to ensure causality

In summary, our results show that an intradialytic VR exercise during the last two hours of the HD session did not result in hemodynamic instability, suggesting that this type of exercise could be safely applied at any time during the HD session without affecting the hemodynamic imbalance.

Those patients who performed VR intradialytic exercise for at least 9 months reduced the consumption of hypertension drugs and improved HDL.

Author Contributions

MTC contributed with data collection, analysis and interpretation of the data and to the manuscript draft and final edition; ACP, AGT, ROR and HLH, NOS gave contributions to the study conception, data collection and design; JAGG, VBC and FJMO contributed in the design and in the manuscript draft; ESO contributed with th funding, study conception and design, data collection, analysis and interpretation of the data and to the manuscript draft. All authors read and approved the final version of the manuscript.

Data available statement: data available statement under request.

Ethical approval:

This study protocol was reviewed and approved by Comité de ética de la Investigación con medicamentos, Hospital Univeristario La Fe, approval number 2018/0833.

Informed consent was obtained from all the participants. The present experimental protocol respected the fundamental principles set out in the Declaration of Helsinki, from the Council of Europe Convention on Human Rights and Biomedicine, and in the UNESCO’s Universal Declaration on the Human Genome and Human Rights. It also met the requirements set out in legislation in accordance with the Data Protection Act for biomedical research, personal data protection, and bioethics.

Informed consent to participate: Study participants were required to sign an informed consent.

Competing interest: The authors have no conflicts of interest to declare.

Data available statement: Data is available within the manuscript or supplementary information files in the research repository Zenodo with the DOI 10.5282/zenodo.11198718. (LINK ACCESS TO ZENODO: http://zenodo.org/record/11198718).

Additional data available under request to Alicia García-Testal, [email protected].

Funding acknowledgement: This study was supported by the Spanish Government ‘Ministerio de Ciencia e Innovación’ (PID2019-108814RA-I00).

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Effect of Intradialysis Virtual Reality Exercise in Hemodinamic Stability: Randomized Trial

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