Comparison of Home- vs. Gym-based Exercise Delivery Modes
Condition: Vascular Stiffness; Cardiorespiratory Fitness
Study type: Interventional

Summary: 
      Home-based exercise interventions were the only alternatives to attenuate physical
      deconditioning and ameliorate traditional and emergent cardiovascular risk factors
      progression during the COVID-19 outbreak. Benefits in physical and psychological health have
      only been reported in adults without intellectual and developmental disability (IDD).

      The purpose of this study is to compare home vs gym-based delivery exercise modes of two
      8-week supervised aerobic training regimes on cardiorespiratory fitness and arterial
      structure and stiffness in adults with IDD.

      It is hypothesized that home- and gym- based exercise delivery modes will be equally
      effective in improving cardiorespiratory fitness and overall arterial heath, although in an
      intensity dependent manner. A secondary analysis examining changes in blood pressure and body
      composition will be performed.
    

Detailed description: 
      A total of 40 participants from the project SPORTS4ALL by Ginásio Clube Português (GCP) were
      recruited to participate in the study. Study advertising took take place through direct
      invitation by the research team and rehabilitation technicians. The time frame for
      recruitment of participants take approximately 1 month. Eligible volunteers were invited to
      an initial meeting with their families/legal guardians, exercise physiologists, and
      rehabilitation technicians. During this meeting, the procedures of the trial, testing
      procedures, benefits, risks, and the time required for the study will be explained. In
      addition, an information sheet about the research and an informed consent form for
      participants and parent(s)/ legal guardian(s), in accordance with the approval by the Ethical
      Committee of Faculdade de Motricidade Humana - Universidade de Lisboa, was distributed.
      Informed written consent were signed by participants and parent(s) legal guardian(s) before
      allocation. After signing the informed consent, participants or parents/legal guardians were
      asked to answer the Physical Activity Readiness Questionnaire for Everyone (PAR-Q+)
      questionnaire, to assess their readiness to increase their levels of physical activity, and a
      sociodemographic data questionnaire. During a second visit, all volunteers participated in
      familiarization sessions before baseline testing at the laboratory. The number of
      familiarization sessions was repeated until the researchers observed that the participants
      are confident and able to perform all assessments correctly (1-2 sessions). Of the 36
      participants recruited, by the time the mandatory COVID-19 home confinement was declared by
      the Portuguese government, only 17 participants had completed laboratorial exercise testing.
      Only these participants were part of the present study.

      This study was a randomized controlled trial, where a convenience group of 17 who had
      completed laboratory exercise tests, were randomized in a 1:1 ratio to an SIT or CAET regime
      by using a random-block randomization scheme. Participants in both aerobic regimes received a
      16-week supervised exercise program performed 3 times a week for 60 min each session. The
      intervention started with 8 weeks of online training via Google Meets at their homes followed
      by 1 month of detraining with no exercise sessions besides those made available by the
      SPORTS4ALL program, and another 8 weeks of on-site training at the gym. During the
      intervention, adherence to the protocols were assessed with an exercise diary. Assessments
      were conducted on 4 occasions over a 20-week period: before (M1; 0 weeks) and after (M2; 8
      weeks) the home-based intervention; and before (M3; 12 weeks) and after (M4; 20 weeks) the
      gym-based intervention. During M1, assessments and personal information was obtained. All
      laboratory tests were conducted by the same researchers during the morning. Participants were
      asked to refrain from eating for at least 3 h, alcohol for 24 h, caffeine for 8 h, and
      vigorous exercise for 48 h before data collection. All laboratorial evaluations were
      performed on a single day of testing at each measurement round. On this day, the participants
      had their (1) body composition measured and then quietly rest for at least 15 min in the
      supine position before data collection in the following order: (2) brachial arterial
      pressure, (3) carotid intima media thickness, (4) stiffness indices by carotid vascular
      ultrasound, (5) regional arterial stiffness by applanation tonometry and (6) an incremental
      test to exhaustion.

      The exercise regimes were delivered at participants' homes for 8 weeks via Google Meets and
      at the gym during an identical period. All sessions were designed by experienced exercise
      physiologists together with rehabilitation technicians, following the guidelines of the
      American College of Sports Medicine (ACSM) and the National Strength and Conditioning
      Association (NSCA). Exercise physiologists in charge of delivering the interventions
      underwent standardized training to ensure that the sessions offered were comparable and went
      through a 2-month familiarization period where they observed the exercise sessions from the
      project SPORTS4ALL by GCP, met the participants, and led exercise activities, while under the
      supervision of the responsible Rehabilitation Technicians of the project SPORTS4ALL. During
      this period, the rating of perceived exertion was reinforced using the OMNI scale. The
      multi-component exercise programs included aerobic, resistance, balance, and flexibility
      training. Both SIT and CAET regimes were divided into 2 groups: 8-9 participants/group and
      the participant-Exercise Physiologist ratio of 3:1, partnered with at least 1 Rehabilitation
      Technician in each exercise session. Both programs were divided into 3 phases: initial phase
      (week 1-3); improvement phase (week 4-6); and maintenance phase (week 7-8). Sessions for both
      regimes were also matched for total duration. All sessions included 5 min of standardized
      warm-up and cool-down exercises. The warm-up was implemented to gradually increase the HR,
      body temperature, joint mobility and prepare the body of the participants to the exercises of
      the conditioning phase. After the conditioning phase, cool-down exercises were performed
      followed by stretching exercises. During the washout period (4 weeks), 14 participants
      performed 3 sessions representing each phase of the home-based intervention wearing heart
      rate monitors to obtain a proxy of the exercise intensity in each phase of the home-based
      intervention. Resistance training included a total of six exercises: 3 for the upper limbs
      (seated biceps curl, triceps extension, and frontal shoulder raise); 2 for the torso (1 for
      the back: seated row and 1 for the abdominals: side bend); and 1 for the lower limbs (chair
      squats). All exercises were performed with 2-4 kg dumbbells, or the participants' body
      weight. The intensity of the strength training was monitored using the 0-10 points Rate of
      Perceived Exertion OMNI- Resistance Exercise Scale (RPE OMNI-RES) validated for resistance
      training. The intensity of resistance training was kept constant at 2 x 12 rep at RPE
      OMNI-RES 8, throughout the study period. Balance training was designed to challenge the
      central and peripheral mechanisms involved in the control of movement and stability
      (vestibular; visual and somatosensory). Flexibility exercises were performed after the
      cool-down period of each session. Sustained stretches were used for each major muscle group
      targeted during the session. Active and passive static stretching exercises were used,
      holding the position for 10-30 s at a point of tightness or slight discomfort.

      Statistical Analyses An intention-to-treat analysis was performed using all randomized
      participants. The data are presented as mean and standard deviation. The Shapiro-Wilk and
      Levene tests, as well as plot inspection, were used to verify normality and homoscedasticity
      assumptions, respectively. To compare baseline individual characteristics independent-samples
      t-tests were used.

      The changes in the cardiorespiratory fitness and vascular outcomes were examined using linear
      mixed models fitted with restricted maximum likelihood and applying Satterthwaite's method
      for approximating degrees of freedom for the F test from the R lmerTest package. The fixed
      effects were time and aerobic regime, whereas the random intercept was defined for each
      participant. Using the R sjstats package, partial eta squares (η2) were calculated for each
      main effect and interaction and interpreted as small (η2 < 0.05), medium (η2 < 0.25), and
      large (η2 > 0.25) effect sizes. In the presence of significant differences in main effects
      and interactions, post-hoc comparisons using Tukey's HSD test were performed using the R
      emmeans package. All statistical analyzes were performed with a significant level (α) of <
      0.05 using the R software, version 4.1.2.
    

Intervention name(s): Home-Based; Gym-Based
Intervention type(s): Behavioral; Behavioral
Intervention description(s): During the home-based intervention, aerobic training was performed using body weight exercises such as jumping jacks, standing box, side shift with floor touch, high knees, half burpee, and hook box (Borrega-Mouquinho et al., 2021).; During the gym-based intervention, aerobic training was performed on cycle ergometers (Star Trac Spinner Blade ION 7220, Vancouver, WA).
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This study was a randomized controlled trial, where a convenience group of 17 were randomized in a 1:1 ratio to an SIT or CAET regime by using a random-block randomization scheme. Participants in both aerobic regimes received a 16-week supervised exercise program performed 3 times a week for 60 min each session. The intervention started with 8 weeks of online training via Google Meets at their homes followed by 1 month of detraining with no exercise sessions besides those made available by the SPORTS4ALL program, and another 8 weeks of on-site training at the gym. During the intervention, adherence to the protocols were assessed with an exercise diary. Schedule of enrolment, intervention, and assessments for the duration of the study are displayed in Supplement 1. Assessments were conducted on 4 occasions over a 20-week period: before (M1; 0 weeks) and after (M2; 8 weeks) the home-based intervention; and before (M3, 12 weeks) and after (M4; 20 weeks) the gym-based intervention.
Masking: Single (Investigator)
Primary purpose: Prevention
Keywords: Covid-19; Pulse wave velocity; Cardiovascular disease; Physical exercise