Cost-effectiveness and Efficacy of Different Physical Exercise Interventions (ExerMOT4Health)

NCT06425679 | Active Not Recruiting

• 1 other identifier: PID2021-123688OB-C31
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 2

Brief Summary

Online exercise has increased in popularity during the pandemic, but there is no evidence of its feasibility and benefits in older people and the influence of motivational strategies. The main aims of this project are: i) To analyze the influence of applying or not motivational strategies during different physical exercise interventions (face-to-face and online) on the effect on mental health, physical health and adherence, according to sex/gender; ii) To analyze and compare the cost-effectiveness and efficacy of face-to-face and online exercise interventions on mental health, physical health and adherence, according to sex/gender. Participants will be 104 community-dwelling older adults (60-75 years) who will be randomized assigned to control, supervised face to face, supervised face to face plus motivation, synchronous online supervised exercise or synchronous online supervised exercise groups. The control group will carry out the usual activities they have been doing, and the intervention groups will participate for 24 weeks in multicomponent exercise intervention. Study assessments will be made before starting the intervention, at the end and after 24 weeks of follow-up. Primary variables will be changes in mental and physical health, assessed by the Trail Making Test, the Yesavage Geriatric Depression Scale, and lower extremity power measured by the sit to stand test. Secondary outcomes will include other parameters of mental and physical health, blood markers, physical activity, and cost-effectiveness analysis. The dropout rate, the attendance at the sessions, the injuries and other adverse events suffered by the participants, and technical incidences produced in the online modality will also be recorded. The results of this project will provide insight into the mental and physical health effects and feasibility of face-to-face and synchronous online supervised physical exercise interventions, and identify older adults' perceptions of the safety, barriers and facilitators of these interventions for future application and transfer to community settings.

Conditions

Physical Inactivity; Healthy Aging; Older Adult

Keywords

Aging; Exercise; Physical activity; Supervised; Home-based; Multidomain training; Multicomponent training; Physical health; Mental health; Quality of life; Physical function; Cost-effectiveness

Outcome Measures

Primary Outcomes (3)

• Neuropsychological Performance

  The Trail-Making Test Part A and B will be administered. Part A is based on number sequencing, participants link numbers from 1 to 25 in ascending order. Part B focuses on alternating numbers and letters in ascending order. The completion time will be registered in seconds (the lower duration, the best performance).

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

• Depression

  The short 15-item version of the Yesavage Geriatric Depression Scale will be used. This is a questionnaire used to screen for depression in older people. This scale consists of 15 items with a yes/no answer pattern, being the minimum score 0 and the maximum 15. The cut-off point for Depression is 5 or more.

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

• Lower-body muscular function

  Lower limb muscle performance will be assessed using the 30-seconds Chair Sit to Stand (30-s CST) test. The number of standing up in 30 seconds will be counted. A higher score, better performance.

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

Secondary Outcomes (34)

• Upper-body muscular function

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

• Maximum walking speed (3, 4, 6 and 10-m)

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

• Usual walking speed (3, 6 and 10-m)

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

• Short Physical Performance Battery (SPPB)

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

• Senior Fitness Test (SFT)

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

Study Arms (5)

Supervised synchronous online exercise intervention without motivational strategies

EXPERIMENTAL

Behavioral: Supervised synchronous online exercise intervention without motivational strategies

Supervised synchronous online exercise intervention with motivational strategies

EXPERIMENTAL

Behavioral: Supervised synchronous online exercise intervention with motivational strategies

Supervised face to face exercise intervention without motivational strategies

EXPERIMENTAL

Behavioral: Supervised face to face exercise intervention without motivational strategies

Supervised face to face exercise intervention with motivational strategies

EXPERIMENTAL

Behavioral: Supervised face to face exercise intervention with motivational strategies

Control group

NO INTERVENTION

Participants will be advised to maintain their usual lifestyle.

Interventions

Supervised synchronous online exercise intervention without motivational strategies BEHAVIORAL

Participants will carry out an online synchronic supervised physical exercise intervention through their computer/tablet or mobile phone at home. The exercise professional will supervise the participant's execution online. The training program comprises the same exercise structure and is based on the same muscle groups and movements as the supervised face to face groups. 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, 2 aerobic exercises, and 6 flexibility exercises. This multicomponent training will be performed 3 times per week (60 min/session) for 24 weeks

Supervised synchronous online exercise intervention without motivational strategies

Supervised synchronous online exercise intervention with motivational strategies BEHAVIORAL

Participants will carry out an online synchronic supervised physical exercise intervention through their computer/tablet or mobile phone at home. The exercise professional will supervise the participant's execution online and will also apply motivational strategies based on self-determination theory. The training program comprises the same exercise structure and is based on the same muscle groups and movements as the supervised face to face groups. 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, 2 aerobic exercises, and 6 flexibility exercises. This multicomponent training will be performed 3 times per week (60 min/session) for 24 weeks.

Supervised synchronous online exercise intervention with motivational strategies

Supervised face to face exercise intervention without motivational strategies BEHAVIORAL

Participants will attend the sports facilities and perform the training in small groups, being supervised by an exercise professional. The training program comprises the same exercise structure and is based on the same muscle groups and movements as the online synchronic supervised groups, but is performed in a sports center. 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, 2 aerobic exercises and 6 flexibility exercises. This multicomponent training will be performed 3 times per week (60 min/session) for 24 weeks.

Supervised face to face exercise intervention without motivational strategies

Supervised face to face exercise intervention with motivational strategies BEHAVIORAL

Participants will attend the sports facilities and perform the training in small groups, being supervised by an exercise professional who will also apply motivational strategies. The training program comprises the same exercise structure and is based on the same muscle groups and movements as the online synchronic supervised groups, but is performed in a sports center. 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, 2 aerobic exercises and 6 flexibility exercises. This multicomponent training will be performed 3 times per week (60 min/session) for 24 weeks.

Supervised face to face exercise intervention with motivational strategies

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 from both sexes aged 60-75 years.
• Not to have diseases and disabilities that limit to be part of exercise interventions or avoid measurements.
• Not perform supervised moderate to vigorous physical activity \>30 minutes and \>3 days/week.
• To be able to communicate without problems.
• To be able to read and understand the aim of the project and informed consent form.
• To have a smartphone, tablet or computer with internet connection.

You may not qualify if:

• Acute or terminal illness.
• Myocardial infarction, coronary artery bypass grafting, angioplasty, angina, or other cardiac conditions 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.
• Uncontrolled Type I or Type II Diabetes.
• History of major psychiatric illness including schizophrenia, generalized anxiety disorder, or depression according to the DSM-5.
• Three or more self-reported falls in the last year.
• Not wanting to complete the study or be assigned to the control group;
• Be participating in another research study that may influence this project.

Sponsors & Collaborators

• University of Cadiz: lead
• Institute of Biomedical research and innovation of Cádiz (INIBICA): collaborator
• Universidad de Almeria: collaborator
• Ministerio de Ciencia e Innovación, Spain: collaborator
• State Research Agency, Spain: collaborator
• European Regional Development Fund: collaborator

Study Sites (2)

Universidad de Almeria

Almería, Almeria, 04120, Spain

Location

University of Cadiz

Puerto Real, Cadiz, 11519, Spain

Location

MeSH Terms

Conditions

Sedentary Behavior; Motor Activity; Psychological Well-Being

Condition Hierarchy (Ancestors)

Behavior; Personal Satisfaction

Study Officials

• Ana Carbonell Baeza, PhD

  University of Cadiz

  PRINCIPAL INVESTIGATOR

• Pablo Jorge Marcos Pardo, PhD

  Universidad de Almeria

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: April 26, 2024
• First Posted: May 22, 2024
• Study Start: November 1, 2023
• Primary Completion: January 30, 2025
• Study Completion: January 30, 2025
• Last Updated: May 22, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

ES (2)