Clinical trial NCT06425679: Cost-effectiveness and Efficacy of Different Physical Exercise Interventions (ExerMOT4Health)
Official title: Cost-effectiveness and Efficacy of Physical Exercise on Mental and Physical Health in Older Adults: Role of Motivational Strategies and Digital Technology
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
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
Lead sponsor: University of Cadiz
Sponsor class: OTHER
Collaborators: name: Institute of Biomedical research and innovation of Cádiz (INIBICA)
name: Universidad de Almeria
name: Ministerio de Ciencia e Innovación, Spain
name: State Research Agency, Spain
name: European Regional Development Fund
First posted: 2024-05-22
Enrollment: 120
Sex: ALL
Minimum age (years): 60
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Neuropsychological Performance
timeFrame: Baseline (week 0), post-intervention (week 25), and follow-up (week 48)
measure: Depression
timeFrame: Baseline (week 0), post-intervention (week 25), and follow-up (week 48)
measure: Lower-body muscular function
timeFrame: Baseline (week 0), post-intervention (week 25), and follow-up (week 48)
Secondary outcomes:
measure: Upper-body muscular function
timeFrame: Baseline (week 0), post-intervention (week 25), and follow-up (week 48)
measure: Maximum walking speed (3, 4, 6 and 10-m)
timeFrame: Baseline (week 0), post-intervention (week 25), and follow-up (week 48).
measure: Usual walking speed (3, 6 and 10-m)
timeFrame: Baseline (week 0), post-intervention (week 25), and follow-up (week 48).
measure: Short Physical Performance Battery (SPPB)
timeFrame: Baseline (week 0), post-intervention (week 25), and follow-up (week 48)
measure: Senior Fitness Test (SFT)
timeFrame: Baseline (week 0), post-intervention (week 25), and follow-up (week 48).
measure: Resting blood pressure
timeFrame: Baseline (week 0), post-intervention (week 25), and follow-up (week 48)
measure: Resting heart rate
timeFrame: Baseline (week 0), post-intervention (week 25), and follow-up (week 48)
measure: Anthropometry
timeFrame: Baseline (week 0), post-intervention (week 25), and follow-up (week 48).
measure: Body perimeters
timeFrame: Baseline (week 0), post-intervention (week 25), and follow-up (week 48).
measure: Body composition
timeFrame: Baseline (week 0), post-intervention (week 25), and follow-up (week 48)
measure: Health-related quality of life
timeFrame: Baseline (week 0), post-intervention (week 25), and follow-up (week 48)
measure: Cognitive Performance- The Montreal Cognitive Assessment
timeFrame: Baseline (week 0), post-intervention (week 25), and follow-up (week 48).
measure: Cognitive Performance-The Stroop Color and Word Test (SCWT)
timeFrame: Baseline (week 0), post-intervention (week 25), and follow-up (week 48).
measure: Cognitive Performance- Digit Span test of the Wechsler Adult Intelligence Scale III
timeFrame: Baseline (week 0), post-intervention (week 25), and follow-up (week 48).
measure: Cognitive Performance-Clock Drawing Test (CDT).
timeFrame: Baseline (week 0), post-intervention (week 25), and follow-up (week 48).
measure: Cognitive Performance- Digit Symbol Substitution Test
timeFrame: Baseline (week 0), post-intervention (week 25), and follow-up (week 48).
measure: Anxiety
timeFrame: Baseline (week 0), post-intervention (week 25), and follow-up (week 48)
measure: Physical activity and sedentary behavior patterns assessed by accelerometry.
timeFrame: Baseline (week 0), post-intervention (week 25), and follow-up (week 48).
measure: Physical activity and sedentary behavior patterns by questionnaire
timeFrame: Baseline (week 0), post-intervention (week 25), and follow-up (week 48).
measure: Sleep assessed by accelerometry
timeFrame: Baseline (week 0), post-intervention (week 25), and follow-up (week 48).
measure: Sleep assessed by questionnaire
timeFrame: Baseline (week 0), post-intervention (week 25), and follow-up (week 48).
measure: Serum BDNF
timeFrame: Baseline (week 0), post-intervention (week 25), and follow-up (week 48).
measure: Serum α-Klotho
timeFrame: Baseline (week 0), post-intervention (week 25), and follow-up (week 48).
measure: Routinary blood serum analysis
timeFrame: Baseline (week 0), post-intervention (week 25), and follow-up (week 48).
measure: Hemogram
timeFrame: Baseline (week 0), post-intervention (week 25), and follow-up (week 48).
measure: Motivators and barriers to exercise
timeFrame: Baseline (week 0), post-intervention (week 25), and follow-up (week 48).
measure: Motivation to exercise according to self-determination theory
timeFrame: Baseline (week 0), post-intervention (week 25), and follow-up (week 48)
measure: Basic Psychological Needs in Exercise
timeFrame: Baseline (week 0), Post-intervention (week 25) and follow-up (week 48)
measure: Satisfaction with Life
timeFrame: Baseline (week 0), post-intervention (week 25), and follow-up (week 48)
measure: Sociodemographic characteristics questionnaire
timeFrame: Baseline (week 0), post-intervention (week 25), and follow-up (week 48)
measure: Cost-Effectiveness Analysis
timeFrame: Through intervention completion (24 weeks)
measure: Adherence to physical training program
timeFrame: Through intervention completion (week 24)
measure: Exercise during follow-up period
timeFrame: Follow-up (week 48)
measure: Falls and adverse events
timeFrame: Through intervention completion (24 weeks)
Other outcomes:
Locations:
city: Almería
country: Spain
facility: Universidad de Almeria
state: Almeria
city: Puerto Real
country: Spain
facility: University of Cadiz
state: Cadiz
Study officials:
affiliation: University of Cadiz
name: Ana Carbonell Baeza, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Universidad de Almeria
name: Pablo Jorge Marcos Pardo, PhD
role: PRINCIPAL_INVESTIGATOR
References: