Ignite Creation Date:
2024-05-06 @ 6:40 PM
Last Modification Date:
2024-10-26 @ 2:52 PM
Study NCT ID:
NCT05744492
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-02-28
First Post:
2023-02-06
Brief Title:
Multicomponent Exercise Program on the Intrinsic Capacity ICOPE of Community-dwelling Older Adults in Primary Care
Sponsor:
European University Spain
Organization:
European University Spain
Study Overview
Official Title:
Effects of a Multicomponent Exercise Program on the Intrinsic Capacity of Community-dwelling Older Adults Under the ICOPE Framework Study Protocol for a Multi-center Randomized Control Trial in Primary Care
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-02
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:
None
Brief Summary:
A three-branch multi-center randomized clinical trial to be conducted in 6 public Primary Care centers located in the city of Madrid Spain A total of 180 older adults 70 years old presenting with declines in the intrinsic capacity IC locomotion domain will be recruited in the participating centers They will be randomized in a 111 ratio to a center-based supervised Vivifrail multicomponent exercise MCE program a home-based non-supervised Vivifrail MCE program or to a control group The intervention consists of thrice-a-week exercise sessions encompassing strength aerobic flexibility and balance and gait training tailored to the individuals baseline functional ability IC will be assessed through its operational domains following ICOPE guidelines at baseline and 6 and 12 weeks after the start of the intervention Secondarily effects on frailty status and health-related quality of life will be evaluated
This study might bring new evidence around the ICOPE recommendation on the Vivifrail MCE for the management of IC locomotion declines in Primary Care for the first time Gaining insight on exercise interventions for IC promotionmaintenance will reinforce current recommendations and contribute to the development of real-world strategies for healthy aging promotion
This study might bring new evidence around the ICOPE recommendation on the Vivifrail MCE for the management of IC locomotion declines in Primary Care for the first time Gaining insight on exercise interventions for IC promotionmaintenance will reinforce current recommendations and contribute to the development of real-world strategies for healthy aging promotion
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