Clinical Trials Logo

Clinical Trial 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06425679
Study type Interventional
Source University of Cadiz
Contact
Status Active, not recruiting
Phase N/A
Start date November 1, 2023
Completion date January 30, 2025

See also
  Status Clinical Trial Phase
Active, not recruiting NCT05659862 - Digitally Assisted Behavioral Physical Activity Intervention in Fibromyalgia N/A
Recruiting NCT05294692 - Using Behavioural Economics for More Sustainable Physical Activity mHealth Incentives: the Caterpillar App N/A
Recruiting NCT05619250 - Supervised Center-based vs. Unsupervised Home-based Exercise Programs (PRO-Training) N/A
Recruiting NCT06088485 - The Effect of Bone Mineral Density in Patients With Adult Cystic Fibrosis
Not yet recruiting NCT05963893 - Promoting a Healthy Life Through Gender Equity
Enrolling by invitation NCT05461989 - Physical Activity Barriers in Adolescent Hypertension Patients
Completed NCT06063187 - Technology-based Fall Risk Assessments for Older Adults in Low-income Settings
Active, not recruiting NCT06089876 - The Use of Mobile Applications in Obese and Overweight Adolescents for Health Improvement N/A
Recruiting NCT05608707 - APPETITE: Plant Protein and Exercise Solutions for the Prevention of Undernutrition in Older Adults. N/A
Enrolling by invitation NCT06033417 - Walking and Blood Pressure in Older Adults With Respiratory Impairment. N/A
Not yet recruiting NCT05887583 - Supporting Physical Literacy at School and Home N/A
Completed NCT05535400 - Effects of Physical-Psychological Integrative Intervention on SCI Patient: a Pilot Randomized Controlled Trial N/A
Recruiting NCT06095999 - Perfect Fit: Evaluation of a Virtual Coach for Smoking Cessation and Physical Activity N/A
Completed NCT06246812 - Text Message and Competition-Based Interventions Among University Students N/A
Recruiting NCT05935982 - Virtual Reality Exercise in a Community Highschool for Children With Disabilities Phase 1
Not yet recruiting NCT06027502 - Cardioprotective Benefit of Passive Heat Therapy in Higher-Level Spinal Cord Injury: Safety and Proof of Concept N/A
Recruiting NCT05147909 - Impact of Dietary Phosphate Excess on Exercise Capacity and Visceral Adiposity N/A
Recruiting NCT06185413 - Children's Cooperation Denmark: a 3-year System Dynamics Trial N/A
Completed NCT06018974 - Digital Gaming Intervention for Older People in Long-term Care N/A
Recruiting NCT05425641 - MoST-Influenced Behavioral Intervention for Walking Phase 2