Ignite Creation Date:
2024-05-06 @ 8:22 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06352749
Status:
RECRUITING
Last Update Posted:
2024-04-08
First Post:
2024-03-17
Brief Title:
Face-to-face vs Online Physical Exercise in Seniors Living in Nursing Homes ExerMOT-NH
Sponsor:
University of the Basque Country UPVEHU
Organization:
University of the Basque Country UPVEHU
Study Overview
Official Title:
Face-to-face vs Online Physical Exercise in Seniors Living in Nursing Homes Randomized Controlled Trial on Its Effects on Health and Quality of Life
Status:
RECRUITING
Status Verified Date:
2024-04
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:
ExerMOT-NH
Brief Summary:
The benefits of multicomponent physical exercise MPE in the mental and physical health of older adults are widely accepted However during Covid19 pandemic some face-to-face programs for physical exercise were canceled The situation was particularly complex in nursing homes NHs because residents were often confined to their floors and many leisure activities were canceled Online physical exercise sessions increased their popularity during the pandemic However there is no evidence that online physical exercise sessions are an effective alternative to face-to-face sessions for older people living in NHs The current project aims to assess a synchronous online MPE programs feasibility acceptability and effects With this aim first a synchronous online MPE intervention was designed and then a multicenter randomized controlled trial with 3 branches was developed face-to-face MPE online MPE and control Participants in the control group will receive advice to maintain physical activity and reduce sedentary behavior Additionally those in the intervention groups will also participate in 24-week individualized and progressive MPE programs performed at moderate intensity that will be focused on strength balance and endurance MPE will be performed through supervised sessions 2 per week One of the intervention groups will be supervised face-to-face whereas the other will be supervised synchronously online Study assessments will be conducted at baseline at the end of the 24-week intervention and after 24-week follow-up The primary outcomes of the study will be changes in mental and physical health Secondary outcomes will include other parameters of mental and physical health together with physical activity frailty quality of life and biological markers The dropout rate the adherence the injuries and other adverse events suffered by the participants and technical incidences produced in the online modality will be recorded A mixed-model ANCOVA will be performed to compare the data between intervention and control groups considering as co-variables baseline measurements The statistical analysis will be performed on the whole sample and separated for sexgender The study received ethical approval M10_2022_405_IRAZUSTA ASTIAZARAN The results of this project will be transferred to institutions and entities involved in managing NHs to increase the opportunities for the residents to remain physically active
Detailed Description:
None
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