Ignite Creation Date:
2024-06-16 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06425679
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-05-22
First Post:
2024-04-26
Brief Title:
Cost-effectiveness and Efficacy of Different Physical Exercise Interventions ExerMOT4Health
Sponsor:
University of Cadiz
Organization:
University of Cadiz
Study Overview
Official Title:
Cost-effectiveness and Efficacy of Physical Exercise on Mental and Physical Health in Older Adults Role of Motivational Strategies and Digital Technology
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ExerMOT4Health
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 sexgender 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 sexgender 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
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 sexgender 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 sexgender 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 N104 community-dwelling older adults aged 60-75 years will be randomized assigned to 1 control 2supervised 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 sessionsweek 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
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 sexgender 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 sexgender 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 N104 community-dwelling older adults aged 60-75 years will be randomized assigned to 1 control 2supervised 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 sessionsweek 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None