Supervised Center-based vs. Unsupervised Home-based Exercise Programs (PRO-Training)
NCT ID: NCT05619250
Last Updated: 2023-11-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
120 participants
INTERVENTIONAL
2022-09-07
2024-12-20
Brief Summary
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Detailed Description
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To date, there is a lack of consensus on the effectiveness, safety, and adherence of unsupervised home-based training programs. Several investigations have shown greater effectiveness on different health variables in exercise programs conducted under the supervision of a professional compared to those performed autonomously at home. However, some studies suggest that a home-based exercise intervention could be as effective as a supervised one. Furthermore, meta-analytical evidence recently published by the research team of this project found that the adherence rate to unsupervised physical exercise programs was low, and the intensity applied was not adequately prescribed. It is important to note that the lack of motivation in unsupervised programs might play an important role in these findings. Thus, the use of motivational strategies that foster autonomous motivation might help increase adherence to unsupervised exercise programs, with this adherence being a key factor for achieving health adaptations.
Therefore, studies analyzing how to cover all these limitations of unsupervised physical exercise are warranted to answer this research question. Along these lines, an adequate prescription of exercise dose and the implementation of motivational techniques could compensate for the lack of physiological stimulus and low adherence typically observed with this type of training program. Furthermore, there is no evidence comparing the cost-effectiveness, safety, and adherence of supervised face-to-face intervention vs online supervised intervention with and without motivational strategies. Under this context, the aim of this randomized controlled trial (RCT) will be to determine the efficacy, cost-effectiveness, safety, and adherence of different exercise training programs with or without supervision and the inclusion of motivational techniques in older adults.
Participants (n= 120; men and women aged 60-75 years old) will be divided into 5 groups: 1- Control group, 2- Unsupervised home-based exercise group without motivational intervention (UNSUP), 3- Unsupervised home-based exercise group with motivational intervention (UNSUP+), 4- Supervised center-based exercise group without motivational intervention (SUP) and 5- Supervised center-based exercise group with motivational intervention (SUP+). Exercise groups will perform physical exercise 3 days a week (1-hour sessions) for 24 weeks, with these sessions being performed from home (with the help of a mobile application that will be developed for this purpose) or at a center with the direct supervision of an exercise professional, according to the assigned group. The primary outcome will be lower-body muscular function. Secondary outcomes will be upper-body muscular function, physical function, cardiorespiratory function, anthropometry and body composition, health-related quality of life, cognitive performance, anxiety and depression status, physical activity and sedentary behavior, sleep, biochemical markers, motivators and barriers to exercise, individual's psychological needs, and level of self-determination. Further, an analysis of the costs of the programs (cost-effectiveness and cost-utility), adherence (rate of adherence to the exercise program), and safety (falls and adverse events) will be carried out.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Unsupervised home-based exercise group without motivational intervention (UNSUP)
Participants will use a mobile application to perform a home-based training program autonomously, without the face-to-face supervision of a specialist during its execution.
Unsupervised home-based exercise group without motivational intervention (UNSUP)
UNSUP will receive a non-supervised physical exercise intervention using a mobile app at home. The UNSUP training program comprises the same exercise structure and is based on the same muscle groups and movements as the supervised groups, but is adapted to be performed at home with the use of elastic bands and the participant's own body weight. The exercise program will be divided into 3 different levels. Each level will contain 3 different sessions including 10 warm-up and joint mobility exercises, 1 balance exercise, 7 strength exercises, 2 aerobic exercises, and 6 flexibility exercises. This multicomponent training will be performed 3 times per week (60 min/session) for 24 weeks.
Unsupervised home-based exercise group with motivational intervention (UNSUP+)
Participants will use a mobile application to perform a home-based training program autonomously, without the face-to-face supervision of a specialist during its execution. As opposed to the "UNSUP" group, the "UNSUP+" group will receive a motivational intervention.
Unsupervised home-based exercise group with motivational intervention (UNSUP+)
UNSUP+ will receive a non-supervised physical exercise intervention using a mobile app at home. The UNSUP+ training program comprises the same exercise structure and is based on the same muscle groups and movements as the supervised groups, but is adapted to be performed at home with the use of elastic bands and the participant's own body weight. The exercise program will be divided into 3 different levels. Each level will contain 3 different sessions including 10 warm-up and joint mobility exercises, 1 balance exercise, 7 strength exercises, 2 aerobic exercises, and 6 flexibility exercises. This multicomponent training will be performed 3 times per week (60 min/session) for 24 weeks. Further, motivational strategies will be applied based on self-determination theory.
Supervised center-based exercise group without motivational intervention (SUP)
Participants will perform a center-based training program in small groups with a maximum of 8 participants per session, being supervised by an exercise professional.
Supervised center-based exercise group without motivational intervention (SUP)
SUP will attend the university facilities and will perform training in small groups, being supervised by an exercise professional. The SUP training program comprises the same exercise structure and is based on the same muscle groups and movements as the unsupervised groups, but is performed in a center using the equipment available at the facility (weight machines, free weight, stationary bikes, etc.). The exercise program will be divided into 3 different levels, progressing the difficulty every 8 weeks. Each level will contain 3 different sessions including 10 warm-up and joint mobility exercises, 1 balance exercise, 7 strength exercises (for upper and lower limbs), 2 aerobic exercises, and 6 flexibility exercises. This multicomponent training will be performed 3 times per week (60 min/session) for 24 weeks.
Supervised center-based exercise group with motivational intervention (SUP+)
Participants will perform a center-based training program in small groups with a maximum of 8 participants per session, being supervised by an exercise professional. As opposed to the "SUP" group, the "SUP+" group will receive a motivational intervention.
Supervised center-based exercise group with motivational intervention (SUP+)
SUP+ will attend the university facilities and will perform training in small groups, being supervised by an exercise professional. The SUP+ training program comprises the same exercise structure and is based on the same muscle groups and movements as the unsupervised groups, but is performed in a center using the equipment available at the facility (weight machines, free weight, stationary bikes, etc.). The exercise program will be divided into 3 different levels, progressing the difficulty every 8 weeks. Each level will contain 3 different sessions including 10 warm-up and joint mobility exercises, 1 balance exercise, 7 strength exercises (for upper and lower limbs), 2 aerobic exercises, and 6 flexibility exercises. This multicomponent training will be performed 3 times per week (60 min/session) for 24 weeks. Further, motivational strategies will be applied based on self-determination theory.
Control group (CON)
Participants will not perform any type of exercise program during the intervention period and will be advised to maintain their usual lifestyle.
No interventions assigned to this group
Interventions
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Unsupervised home-based exercise group without motivational intervention (UNSUP)
UNSUP will receive a non-supervised physical exercise intervention using a mobile app at home. The UNSUP training program comprises the same exercise structure and is based on the same muscle groups and movements as the supervised groups, but is adapted to be performed at home with the use of elastic bands and the participant's own body weight. The exercise program will be divided into 3 different levels. Each level will contain 3 different sessions including 10 warm-up and joint mobility exercises, 1 balance exercise, 7 strength exercises, 2 aerobic exercises, and 6 flexibility exercises. This multicomponent training will be performed 3 times per week (60 min/session) for 24 weeks.
Unsupervised home-based exercise group with motivational intervention (UNSUP+)
UNSUP+ will receive a non-supervised physical exercise intervention using a mobile app at home. The UNSUP+ training program comprises the same exercise structure and is based on the same muscle groups and movements as the supervised groups, but is adapted to be performed at home with the use of elastic bands and the participant's own body weight. The exercise program will be divided into 3 different levels. Each level will contain 3 different sessions including 10 warm-up and joint mobility exercises, 1 balance exercise, 7 strength exercises, 2 aerobic exercises, and 6 flexibility exercises. This multicomponent training will be performed 3 times per week (60 min/session) for 24 weeks. Further, motivational strategies will be applied based on self-determination theory.
Supervised center-based exercise group without motivational intervention (SUP)
SUP will attend the university facilities and will perform training in small groups, being supervised by an exercise professional. The SUP training program comprises the same exercise structure and is based on the same muscle groups and movements as the unsupervised groups, but is performed in a center using the equipment available at the facility (weight machines, free weight, stationary bikes, etc.). The exercise program will be divided into 3 different levels, progressing the difficulty every 8 weeks. Each level will contain 3 different sessions including 10 warm-up and joint mobility exercises, 1 balance exercise, 7 strength exercises (for upper and lower limbs), 2 aerobic exercises, and 6 flexibility exercises. This multicomponent training will be performed 3 times per week (60 min/session) for 24 weeks.
Supervised center-based exercise group with motivational intervention (SUP+)
SUP+ will attend the university facilities and will perform training in small groups, being supervised by an exercise professional. The SUP+ training program comprises the same exercise structure and is based on the same muscle groups and movements as the unsupervised groups, but is performed in a center using the equipment available at the facility (weight machines, free weight, stationary bikes, etc.). The exercise program will be divided into 3 different levels, progressing the difficulty every 8 weeks. Each level will contain 3 different sessions including 10 warm-up and joint mobility exercises, 1 balance exercise, 7 strength exercises (for upper and lower limbs), 2 aerobic exercises, and 6 flexibility exercises. This multicomponent training will be performed 3 times per week (60 min/session) for 24 weeks. Further, motivational strategies will be applied based on self-determination theory.
Eligibility Criteria
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Inclusion Criteria
* Being able to speak and read fluent Spanish.
* Being able to walk independently.
* Being physically able to participate in an exercise program.
* Having a smartphone and being able to understand and use mobile applications autonomously.
Exclusion Criteria
* Myocardial infarction, coronary artery bypass grafting, angioplasty, angina, or other cardiac condition in the past year.
* Uncontrolled medical problems that the general practitioner considers would preclude patients from undertaking the exercise program (e.g., acute systemic illness such as pneumonia, acute rheumatoid arthritis, and acute or unstable heart failure).
* Conditions requiring a specialized physical exercise program (e.g., uncontrolled epilepsy, significant neurological disease or impairment, inability to maintain an upright seated position or unable to move independently, multiple sclerosis, cancer, Parkinson's, Alzheimer's, or chronic obstructive pulmonary disease).
* General practitioner-diagnosed hypertension that has not been controlled.
* Type I Diabetes or uncontrolled Type II Diabetes.
* History of major psychiatric illness including schizophrenia, generalized anxiety disorder, or depression according to the DSM-5.
* Morbid obesity (body mass index \>39)
* Three or more self-reported falls in the last year.
* Not living in the community (e.g., living in nursing homes).
* Having participated in an exercise program during the 6 months prior to the study.
* Diagnosis of COVID-19 with hospitalization in intensive care unit.
* Any other consideration that interferes with the study aims and could be a risk to the participant, at the discretion of the researcher and the general practitioner.
60 Years
75 Years
ALL
Yes
Sponsors
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Biomedical Research Networking Center on Frailty and Healthy Aging (CIBERFES)
UNKNOWN
Complejo Hospitalario de Toledo
OTHER
University of Castilla-La Mancha
OTHER
Responsible Party
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Asier Mañas Bote
Principal investigator
Principal Investigators
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Asier Mañas, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
GENUD Toledo Research Group, University of Castilla-La Mancha
Locations
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University of Castilla-La Mancha
Toledo, Castilla-La Mancha/Toledo, Spain
Countries
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Central Contacts
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Facility Contacts
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References
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Gomez-Redondo P, Alcazar J, Valenzuela PL, Ara I, Alegre LM, Manas A. Validity of repetitions in reserve for prescribing resistance exercise in older adults. Exp Gerontol. 2025 Oct 15;210:112884. doi: 10.1016/j.exger.2025.112884. Epub 2025 Sep 2.
Leal-Martin J, Munoz-Munoz M, Sierra-Ramon M, Cerezo-Arroyo M, Gomez-Redondo P, Alegre LM, Ara I, Garcia-Garcia FJ, Manas A. Metabolic equivalents intensity thresholds for physical activity classification in older adults. Eur Rev Aging Phys Act. 2024 May 21;21(1):14. doi: 10.1186/s11556-024-00348-5.
Gomez-Redondo P, Valenzuela PL, Martinez-de-Quel O, Sanchez-Martin C, Cerezo-Arroyo M, Moreno-Manzanaro D, Alegre LM, Guadalupe-Grau A, Ara I, Manas A. The role of supervision and motivation during exercise on physical and mental health in older adults: a study protocol for a randomized controlled trial (PRO-Training project). BMC Geriatr. 2024 Mar 20;24(1):274. doi: 10.1186/s12877-024-04868-8.
Other Identifiers
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CEIC-CHTO-881
Identifier Type: -
Identifier Source: org_study_id