Study Design
This single-center randomized controlled trial of healthy adults was conducted in accordance with CONSORT (consolidated standards of reporting trial) guidelines and the principles of the Declaration of Helsinki. The study protocol was approved by the Institutional Review Board and Ethics Committee of our institution (no. 2021-11-076).
All procedures were performed with adequate understanding and written informed consent was obtained from all participants.
Study Participants
Participants were recruited through paper-based and online advertisements in the Department of Rehabilitation Medicine of a tertiary hospital. The enrollment was conducted between February and May 2023. In total, 20 individuals were enrolled and randomly allocated to each arm (the intervention and control groups) in a 1:1 ratio. Participants who met the following inclusion criteria were recruited to participate in the study: (1) aged 18 years or older; (2) agreed to participate in the study voluntarily; (3) able to use mobile devices, including installing and using mobile applications; and (4) able to understand and perform the exercise protocol at home and provide feedback without difficulty. The exclusion criteria included: (1) medical problems or physical disabilities that would prevent participation in exercise and (2) inability to read and understand the exercise manual.
Exercise Protocol
Before each exercise session, both intervention and control group participants wore a heart rate (HR) sensor (exa-i; Shenzhen Chileaf Electronics, China) on either their right or left forearm to monitor their HR. They were instructed to exercise using a stationary bicycle for a minimum of 150 minutes per week based on the WHO PA guidelines.[11] Participants were required to perform each exercise session for a minimum of 30 minutes, including 3-minute warm-up and cool-down phases.
The entire exercise program was performed for 6 weeks. Exercise intensity was increased weekly using the calculated HR based on the Karvonen formula.[23] Participants began the program by exercising at an intensity of resting HR + 50% of HR reserve (HRR) in the first week and gradually increased to an intensity level as follows: (second week, resting HR + 60% of HRR; third week, resting HR + 65% of HRR; fourth week, resting HR + 70% of HRR; fifth week, resting HR + 75% of HRR). Finally, in the sixth week, exercise was performed at an intensity of resting HR + 80% of HRR. The HR, measured in real-time, was displayed on a screen.
Intervention with Mobile Application
In the intervention group, participants were instructed to install the mobile app, Clinic C (UNIVR, Daejeon, South Korea) on a tablet and were educated on how to use the application before starting the exercise. When the participants run the application, a message regarding the link between the HR sensor and the bicycle appears. When the connection between the application and bicycle is confirmed, the HR sensor moves on to a screen to record simple personal information, current exercise weeks, and target exercise time. Subsequently, the virtual reality game screen appears, and the exercise begins.
The target HR of the session is automatically calculated based on the resting HR measured using an HR sensor (Fig. 1a) and presented on the screen during the game. The virtual reality game consists of a warm-up, the main exercise, and a cool-down. There is a game character in the middle of the screen. When the participants begin cycling, the wireless sensor embedded in the bicycle monitors their speed and reflects it by adjusting the speed of the character. At the top of the screen, the target HR is displayed as a yellow line in the middle, and the current HR is displayed in red. The relative amount of time elapsed since the start of the exercise is shown as a bar graph on the left-hand side of the screen (Fig. 1b). When the participant’s HR is lower than the target HR, comics are displayed on the screen to encourage the participant to exert more effort (Fig. 1c). After each session, the achievement rate of the target HR, total exercise time, and actual exercise time are displayed on the screen (Fig. 1d). In contrast, the control group underwent the same exercise protocol without using the mobile application.
Measures
All participants were assessed at baseline and 6 weeks post-intervention. Measurements included body composition analysis, isokinetic muscle strength tests, and cardiopulmonary exercise test (CPET). All measurements were performed by the same experienced physiotherapist who was blinded to the study.
Body Composition Measurement
Using an automatic height- and weight-measuring device, BSM370 (Biospace, Chungnam, South Korea), the participants’ height (cm) and weight (kg) were measured to the first decimal place in an upright position without shoes. Body composition was determined by BIA using InBody S10 (InBody, Seoul, South Korea). Participants stood barefoot on two-foot electrodes and gently held two hand electrodes placed in the palm of their hand with their fingers wrapped around the hand electrode so that the palms, fingers, and soles could be in contact with the electrodes during the test. The skeletal muscle mass (SMM), percentage body fat (PBF), visceral fat area (VFA), segmental lean analysis (SLA), and phase angle (PA) of both legs were measured using BIA.
Isokinetic Strength Test
To measure lower extremity muscle strength, bilateral isokinetic knee flexor and extensor strength tests were performed. Before the test, each participant was required to cross their arms over the chest, and Velcro straps were used to fix the trunk, pelvis, and thighs in place to minimize body compensation. At an angular velocity of 60°/s, using an isokinetic dynamometer (Medical Systems 4, BIODEX, USA), the participants were required to perform five maximal repetitions of flexion and extension in both legs after submaximal trials for adaptation. The peak torque generated over five repetitions was recorded, and the peak torque per body weight was calculated.
Cardiopulmonary Exercise Test
To determine the exercise capacity of the participants, experienced physiotherapists performed the incremental CPET with 12-lead electrocardiographic monitoring on a treadmill (Marquette T2000, GE HealthCare, USA). The participants underwent symptom-limited exercise testing using a Korea Institute of Sports Science protocol developed for the evaluation of national athletes. A breath-by-breath expired gas analyzer (Quark CPET, COSMED, Italy), blood pressure monitor, and pulse monitor were used during testing. Termination of the CPET was done by following the guidelines set by the American Heart Association (AHA).[24]
An oxygen consumption (VO2) peak was determined as the highest recorded VO2 value during a given 15-second interval within the last 90 seconds of exercise.[25] Anaerobic threshold (AT) refers to VO2 at the onset of blood lactate accumulation and is the point at which minute ventilation increases disproportionately relative to VO2; the AT is generally observed at 60–70% of VO2max.[26, 27] VO2 peak, predictive percentage, and VO2 values over the AT were used for the study.
Achieved Target HR Percentage
For each exercise session, the exercise time and HR were automatically recorded on a mobile platform. These data were used to calculate the total exercise time for each week and the percentage of time spent within the target HR range (target HR ± 10 beats per minute). These parameters were used to assess the intergroup difference in the rate of reaching the target HR and thereby evaluate the effectiveness and feasibility of the mobile application as an adjunctive tool for promoting physical activity during HBE.
Statistical Analysis
Demographic and clinical characteristics are presented as means and standard deviations. Baseline characteristics were compared using the Mann–Whitney U test for continuous variables and the chi-square test for dichotomous variables. Statistical analyses included the Mann–Whitney U test for intergroup comparisons and Wilcoxon signed-rank tests for within-group comparisons. All statistical analyses were performed using SPSS version 29.0 (SPSS, Chicago, IL, USA). The level of statistical significance was 0.05.