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

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

Interventions

BEHAVIORAL

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.

BEHAVIORAL

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.

BEHAVIORAL

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.

BEHAVIORAL

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.

Sponsors & Collaborators

• Biomedical Research Networking Center on Frailty and Healthy Aging (CIBERFES)

  collaborator UNKNOWN

• Complejo Hospitalario de Toledo

  collaborator OTHER

• University of Castilla-La Mancha

  lead OTHER

Principal Investigators

• Asier Mañas, Ph.D. · GENUD Toledo Research Group, University of Castilla-La Mancha

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

60 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2022-09-07

Primary Completion

2024-07-19

Completion

2024-12-20

Countries

• Spain

Study Locations