Comparison of Home- vs. Gym-based Exercise Delivery Modes

NCT05701943 | Completed

• 1 other identifier: UPSIDE DOWNS
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Vascular Stiffness; Cardiorespiratory Fitness

Keywords

Covid-19; Pulse wave velocity; Cardiovascular disease; Physical exercise

Outcome Measures

Primary Outcomes (2)

• Change in Cardiorespiratory Fitness

  Each participant performed a ramp incremental cycle ergometer test to exhaustion on a calibrated electronically braked cycle ergometer (Monark 839 E, Ergomedic; Monark, Vansbro, Sweden) at a pedal cadence of 70-75 rev.min-1. The initial and incremental workloads were 10-20 watts. Inspired and expired gases were continuously analyzed, with mixing-chamber gas exchange measurements using a portable gas analyzer (K5, Cosmed, Rome, Italy). Before each test, the O2 and CO2 analyzers were calibrated using ambient air and standard calibration gases of known concentration (16.7% O2 and 5.7% CO2). Heart rate was continuously monitored (Garmin, US) and the participants did not carry the gas analyzer. Data were evaluated in 10 s averages, and peak VO2 (mL/kg/min) was defined as the highest 20-second value attained in the last minute.

  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.

• Change in Arterial Stiffness

  Arterial stiffness as measured by PWV (m/s) from piezoelectric pressure mechanotransducers placed on the carotid, femoral and distal posterior tibial arteries on the right side of the body. The operator positioned the carotid sensor with the help of its specific holder and manually held the femoral sensor on the femoral artery and the distal sensor on the distal posterior tibial artery. The right common carotid artery also was scanned with an Arietta V60 ultrasound machine (Hitachi Aloka Medical Ltd, Mitaka-shi, Japan) using a 7.5-MHz linear array probe incorporating a 5-MHz Doppler transducer. In longitudinal view, the intima of the artery was clearly imaged from both the anterior and posterior walls, and a single scan line was aligned perpendicularly to the vessel walls at a site 20 mm proximal to the carotid bulb. The corresponding displacement waveforms and diameter curve were thus calculated using high-resolution online wall tracking technology, with a sampling rate of 1 kHz.

  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.

Secondary Outcomes (4)

• Change in Arterial Structure

  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.

• Change in Body Mass Index

  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.

• Change in Body Composition

  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.

• Change in Waist Circumference

  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.

Study Arms (2)

Sprint Interval Training

EXPERIMENTAL

The SIT consisted of a combination of aerobic, resistance, balance, and flexibility exercises. Exercise started with 5 min of warm-up followed by bouts of 5-10 min of exercise consisting of 5-20 s all-out sprints followed by 15-45 s of low cadence recovery (1:3-1:2 work-rest ratio). The duration of the sprints and active recovery were modified throughout the program. To ensure that participants exercised at the appropriate intensity, the OMNI scale 8-10 (Stanish \& Aucoin, 2007) was applied during the home intervention, and an HR chest band (H10 Polar, Electro, Kempele, Finland) was used during the gym intervention.

Behavioral: Home-Based; Behavioral: Gym-Based

Continuous Aerobic Exercise Training

ACTIVE COMPARATOR

CAET was based on a combination of aerobic, resistance, balance, and flexibility exercises. The exercise on the cycle ergometer started with 5-min of warm-up followed by 3 bouts of continuous cycling at a steady-state intensity. The duration of the bouts (5-10 min) and the intensity (55-85% HRR) were progressively increased throughout each phase. To ensure that the participants exercised at the appropriate intensity, the OMNI scale 4-6 (Stanish \& Aucoin, 2007) was used during the home-based intervention, and an HR chest band (H10 Polar, Electro, Kempele, Finland) was worn during the gym-based intervention.

Behavioral: Home-Based; Behavioral: Gym-Based

Interventions

Home-Based BEHAVIORAL

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).

Continuous Aerobic Exercise Training; Sprint Interval Training

Gym-Based BEHAVIORAL

During the gym-based intervention, aerobic training was performed on cycle ergometers (Star Trac Spinner Blade ION 7220, Vancouver, WA).

Continuous Aerobic Exercise Training; Sprint Interval Training

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• ≥ 18 years and ≤ 55 years
• diagnosed with mild to moderate IDD
• exercised at least 1 d/wk in the last 2 months
• able to participate on group exercise activities with ≥ 8 people
• able to walk independently
• and able to understand and perform all physical fitness assessments.

You may not qualify if:

• any form of cardiovascular disease
• significant respiratory disorder
• metabolic disease
• atlanto-axial instability
• severe or profound IDD
• smoking
• and/or use of heart rate (HR) and blood pressure altering or non-steroidal anti-inflammatory medications
• inability to comply with guidelines for participation in exercise testing and training.

Sponsors & Collaborators

• Egas Moniz - Cooperativa de Ensino Superior, CRL: lead
• Ginásio Clube Português: collaborator
• Faculdade de Motricidade Humana - Universidade de Lisboa: collaborator
• Universidade Europeia: collaborator

Study Sites (1)

Ginásio Clube Português

Lisbon, 1250-111, Portugal

Location

Related Publications (5)

• Oviedo GR, Guerra-Balic M, Baynard T, Javierre C. Effects of aerobic, resistance and balance training in adults with intellectual disabilities. Res Dev Disabil. 2014 Nov;35(11):2624-34. doi: 10.1016/j.ridd.2014.06.025. Epub 2014 Jul 18.

  PMID: 25041876 BACKGROUND

• Oviedo GR, Javierre C, Font-Farre M, Tamulevicius N, Carbo-Carrete M, Figueroa A, Perez-Testor S, Cabedo-Sanroma J, Moss SJ, Masso-Ortigosa N, Guerra-Balic M. Intellectual disability, exercise and aging: the IDEA study: study protocol for a randomized controlled trial. BMC Public Health. 2020 Aug 20;20(1):1266. doi: 10.1186/s12889-020-09353-6.

  PMID: 32819350 BACKGROUND

• Borrega-Mouquinho Y, Sanchez-Gomez J, Fuentes-Garcia JP, Collado-Mateo D, Villafaina S. Effects of High-Intensity Interval Training and Moderate-Intensity Training on Stress, Depression, Anxiety, and Resilience in Healthy Adults During Coronavirus Disease 2019 Confinement: A Randomized Controlled Trial. Front Psychol. 2021 Feb 24;12:643069. doi: 10.3389/fpsyg.2021.643069. eCollection 2021.

  PMID: 33716913 BACKGROUND

• Thompson PD, Arena R, Riebe D, Pescatello LS; American College of Sports Medicine. ACSM's new preparticipation health screening recommendations from ACSM's guidelines for exercise testing and prescription, ninth edition. Curr Sports Med Rep. 2013 Jul-Aug;12(4):215-7. doi: 10.1249/JSR.0b013e31829a68cf. No abstract available.

  PMID: 23851406 BACKGROUND

• Melo X, Simao B, Catela C, Oliveira I, Planche S, Louseiro A, Maroco JL, Oviedo GR, Fernhall B, Santa-Clara H. Home- vs gym-based exercise delivery modes of two multicomponent intensity training regimes on cardiorespiratory fitness and arterial stiffness in adults with intellectual and developmental disability during the COVID-19 pandemic - a randomized controlled trial. J Intellect Disabil. 2025 Mar;29(1):66-85. doi: 10.1177/17446295241242507. Epub 2024 Mar 27.

  PMID: 38537027 DERIVED

MeSH Terms

Conditions

COVID-19; Cardiovascular Diseases; Motor Activity

Interventions

Home Care Services, Hospital-Based

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Behavior

Intervention Hierarchy (Ancestors)

Home Care Services; Community Health Services; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Xavier Melo, PhD

  Egas Moniz School of Health and Science

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: January 4, 2023
• First Posted: January 27, 2023
• Study Start: November 2, 2020
• Primary Completion: July 30, 2021
• Study Completion: July 30, 2021
• Last Updated: January 27, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will share
• Time Frame: Data requests can be submitted starting 9 months after article publication and the data will be made accessible for up to 24 months. Extensions will be considered on a case-by-case basis
• Access Criteria: Access to trial IPD can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information or to submit a request, please contact xmelo@egasmoniz.edu.pt.

Locations

PT (1)