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

University of Cadiz

Status: Active, not recruiting

Conditions: Physical Inactivity; Older Adult; Healthy Aging

Treatments: Behavioral: Supervised face to face exercise intervention without motivational strategies; Behavioral: Supervised synchronous online exercise intervention without motivational strategies; Behavioral: Supervised synchronous online exercise intervention with motivational strategies; Behavioral: Supervised face to face exercise intervention with motivational strategies

Study type: Interventional

Funder types: Other

Identifiers

NCT06425679

PID2021-123688OB-C31

Details and patient eligibility

About

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.

Full description

Scientific evidence has demonstrated the effects of multicomponent physical exercise on the mental and physical health of community-dwelling older people. Despite this, the interest of some older people in exercise is low and even a low percentage of older people practice it with sufficient frequency and intensity to obtain benefits in their mental and physical health. Recent studies have demonstrated the importance of using motivational strategies to generate adherence to exercise, but there are still no studies with community-dwelling older adults. Furthermore, the Covid-19 pandemic has shown that face-to-face physical exercise is not always possible, so it is necessary to have alternatives in case situations of social isolation and mobility restrictions return. It is also important to note that many older people have difficulty traveling to a sports center or living in rural environments, which makes it difficult to practice exercise regularly. Online exercise has increased in popularity during the pandemic, but there is no evidence of its feasibility and benefits in older people.

The specific aims of this study are:

1. To analyze the influence of applying or not motivational strategies during supervised face-to-face and synchronous online physical exercise interventions on the effect on mental health, physical health and adherence, according to sex/gender in the community setting.
2. To analyze and compare the cost-effectiveness and efficacy of supervised face-to-face and synchronous online exercise interventions vs usual lifestyle on mental health, physical health and adherence, according to sex/gender in the community setting, in short and long term (follow up).
3. To design and evaluate the feasibility of supervised face-to-face and synchronous online exercise interventions and to identify older adults' perceptions of safety, barriers and facilitators of supervised face-to-face and synchronous online physical exercise interventions for future application and transfer to the community setting.
4. To create audio-visual resources that explain how to implement safe face-to-face and synchronous online supervised physical exercise interventions in older men and women that promote adherence, based on scientific evidence, in the community setting.

Participants (N=104 community-dwelling older adults aged 60-75 years) will be randomized assigned to: 1) control, 2)supervised face to face, 3) supervised face to face plus motivation, 4) synchronous online supervised exercise or 5) 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 3 sessions/week of multicomponent exercise intervention, being performed from home (online groups) or at a sport center, according to the assigned group. Each session will last 60 minutes and will include 10 warm-up and joint mobility exercises, 1 balance exercise, 7 strength exercises, 2 aerobic exercises, and 6 flexibility exercises.

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. We will also record 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.

Enrollment: 120 patients

Sex: All

Ages: 60 to 75 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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120 participants in 5 patient groups

Supervised synchronous online exercise intervention without motivational strategies

Experimental group

Treatment:

Behavioral: Supervised synchronous online exercise intervention without motivational strategies

Supervised synchronous online exercise intervention with motivational strategies

Experimental group

Treatment:

Behavioral: Supervised synchronous online exercise intervention with motivational strategies

Supervised face to face exercise intervention without motivational strategies

Experimental group

Treatment:

Behavioral: Supervised face to face exercise intervention without motivational strategies

Supervised face to face exercise intervention with motivational strategies

Experimental group

Treatment:

Behavioral: Supervised face to face exercise intervention with motivational strategies

Control group

No Intervention group

Description:

Participants will be advised to maintain their usual lifestyle.