Supervised Center-based vs. Unsupervised Home-based Exercise Programs (PRO-Training)

NCT05619250 | Unknown DMC

• 1 other identifier: CEIC-CHTO-881
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

The superiority of supervised center-based training programs compared with unsupervised home-based ones in older adults remains unclear, and no evidence exists on whether including a motivational component could moderate these differences. The present randomized controlled trial aims to determine the role of supervision and motivational strategies on the safety, adherence, efficacy, and cost-effectiveness of different training programs for improving physical and mental health in older adults. Participants (n=120, aged 60-75 years old) will be randomly divided into five 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+). Participants assigned to the exercise groups will participate in a 24-week multicomponent exercise program (3 sessions/week, 60 min/session), while participants in the control group will be asked to maintain their usual lifestyle. Physical and mental health outcomes will be assessed, including lower and 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. Assessments will be conducted at baseline (week 0), mid-intervention (week 12), at the end of the intervention period (week 25), and 24 weeks after the exercise intervention (week 48).

Conditions

Physical Inactivity; Healthy; Older Adult

Keywords

Aging; Exercise; Physical activity; Supervised; Center-based; Unsupervised; Home-based; App-based; mHealth; Mobile app; Multicomponent training; Physical health; Mental health; Quality of life; Physical function; Cost-effectiveness

Outcome Measures

Primary Outcomes (4)

• Lower-body muscular function

  The force-velocity relationship and the rate of force development (RFD) will be assessed on a horizontal leg press device (Technogym, Element, Italy) instrumented with a force plate (Type 9286BA, Kistler, Switzerland) and a linear position transducer device (TForce System, Ergotech, Spain). A familiarization session will be performed in session one before the evaluation day in session number three.

  Baseline (week 0), mid-intervention (week 12), post-intervention (week 25), and follow-up (week 48).

• Costs

  Researchers will calculate total costs and costs per participant for each of the intervention groups. Mean difference in quality-adjusted life-year (QALY) scores at the end of the intervention will be assessed to analyze the cost-utility. Furthermore, an incremental cost-effectiveness ratio (ICER) will be assessed. Data on health-related quality of life measured by EQ-5D will be used for the calculations.

  Through intervention completion, that is 24 weeks.

• Adherence to physical training program

  Adherence to physical training program will be recorded in the unsupervised training groups using the mobile app. Trainers will record adherence to physical training program in the supervised training groups. It will be calculated as a percentage (\[sessions completed/total sessions expected\] x 100), where 0 % indicates total non-adherence and 100 % indicates full adherence to the exercise prescription. During the 24-week follow-up, we will assess through an ad-hoc self-reported questionnaire whether or not participants exercised, the exercise modality performed (supervised center-based and/or unsupervised home-based), and the number of weekly exercise sessions performed. The questionnaire will be administered on a weekly basis in written form.

  Through study completion, that is 48 weeks.

• Falls and adverse events

  Participants in the unsupervised and control groups will record in a diary their falls and adverse events during and outside exercise sessions. In the supervised groups, supervisors will register the incidence of falls during exercise sessions and participants will register them outside the exercise sessions using the diary.

  Through intervention completion, that is 24 weeks.

Secondary Outcomes (19)

• Upper-body muscular function

  Baseline (week 0), mid-intervention (week 12), post-intervention (week 25), and follow-up (week 48).

• Maximum walking speed (10-m)

  Baseline (week 0), mid-intervention (week 12), post-intervention (week 25), and follow-up (week 48).

• Usual walking speed (3, 6 and 10-m)

  Baseline (week 0), mid-intervention (week 12), post-intervention (week 25), and follow-up (week 48).

• Short Physical Performance Battery (SPPB)

  Baseline (week 0), mid-intervention (week 12), post-intervention (week 25), and follow-up (week 48).

• Senior Fitness Test (SFT)

  Baseline (week 0), mid-intervention (week 12), post-intervention (week 25), and follow-up (week 48).

Study Arms (5)

Unsupervised home-based exercise group without motivational intervention (UNSUP)

EXPERIMENTAL

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.

Behavioral: Unsupervised home-based exercise group without motivational intervention (UNSUP)

Unsupervised home-based exercise group with motivational intervention (UNSUP+)

EXPERIMENTAL

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.

Behavioral: Unsupervised home-based exercise group with motivational intervention (UNSUP+)

Supervised center-based exercise group without motivational intervention (SUP)

EXPERIMENTAL

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.

Behavioral: Supervised center-based exercise group without motivational intervention (SUP)

Supervised center-based exercise group with motivational intervention (SUP+)

EXPERIMENTAL

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.

Behavioral: Supervised center-based exercise group with motivational intervention (SUP+)

Control group (CON)

NO INTERVENTION

Participants will not perform any type of exercise program during the intervention period and will be advised to maintain their usual lifestyle.

Interventions

Unsupervised home-based exercise group without motivational intervention (UNSUP) BEHAVIORAL

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 without motivational intervention (UNSUP)

Unsupervised home-based exercise group with motivational intervention (UNSUP+) BEHAVIORAL

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.

Unsupervised home-based exercise group with motivational intervention (UNSUP+)

Supervised center-based exercise group without motivational intervention (SUP) BEHAVIORAL

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 without motivational intervention (SUP)

Supervised center-based exercise group with motivational intervention (SUP+) BEHAVIORAL

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.

Supervised center-based exercise group with motivational intervention (SUP+)

Eligibility Criteria

• Age: 60 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• People aged between 60 and 75 years old.
• 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.

You may not qualify if:

• Acute or terminal illness.
• 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.

Sponsors & Collaborators

• University of Castilla-La Mancha: lead
• Biomedical Research Networking Center on Frailty and Healthy Aging (CIBERFES): collaborator
• Complejo Hospitalario de Toledo: collaborator

Study Sites (1)

University of Castilla-La Mancha

Toledo, Castilla-La Mancha/Toledo, 45007, Spain

RECRUITING

Related Publications (3)

• 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.

  PMID: 40902458 DERIVED

• 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.

  PMID: 38773408 DERIVED

• 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.

  PMID: 38509514 DERIVED

MeSH Terms

Conditions

Sedentary Behavior; Motor Activity; Psychological Well-Being

Condition Hierarchy (Ancestors)

Behavior; Personal Satisfaction

Study Officials

• Asier Mañas, Ph.D.

  GENUD Toledo Research Group, University of Castilla-La Mancha

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Asier Mañas, Ph.D.

CONTACT

+34 925268800; asier.manas@uclm.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: November 2, 2022
• First Posted: November 16, 2022
• Study Start: September 7, 2022
• Primary Completion: July 19, 2024
• Study Completion: December 20, 2024
• Last Updated: November 28, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)