Ignite Creation Date:
2025-12-25 @ 4:13 AM
Ignite Modification Date:
2025-12-26 @ 3:12 AM
Study NCT ID:
NCT01561820
Status:
COMPLETED
Last Update Posted:
2019-09-26
First Post:
2012-03-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Mild Cognitive Impairment, Buddy Supported Exercise/ My Buddy Study
Sponsor:
Wake Forest University
Organization:
Study Overview
Official Title:
Community-based, Buddy-supported Exercise in Patients With MCI: a Pilot Trial
Status:
COMPLETED
Status Verified Date:
2019-09
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:
This is a small pilot trial of a 5 month aerobic exercise intervention in participants with MCI (n=20) to begin to compare the effects of randomization to use an exercise buddy or to exercise without an assigned buddy. The investigators hypothesize that participants with MCI who exercise with a buddy will have higher adherence to the protocol and greater improvement in 400 meter walk time.
Detailed Description:
The overall objective of this pilot study is to determine feasibility and gather data that will inform the design of a larger, multicenter, randomized, controlled trial. Specifically, the investigators aim to:
2.1 Determine the feasibility of recruiting persons with MCI and a buddy for an exercise intervention.
\- For MCI participants who do not identify a buddy, the investigators will determine the interest and feasibility of recruiting volunteers from the community to be an exercise buddy.
2.2 Determine the effects of having an exercise buddy on:
* adherence to the protocol
* 400 meter walk time, an objective measure of improved physical fitness
* retention and satisfaction for both participant with MCI and buddy
2.3 Establish a scientific partnership with a community based exercise facility.
2.1 Determine the feasibility of recruiting persons with MCI and a buddy for an exercise intervention.
\- For MCI participants who do not identify a buddy, the investigators will determine the interest and feasibility of recruiting volunteers from the community to be an exercise buddy.
2.2 Determine the effects of having an exercise buddy on:
* adherence to the protocol
* 400 meter walk time, an objective measure of improved physical fitness
* retention and satisfaction for both participant with MCI and buddy
2.3 Establish a scientific partnership with a community based exercise facility.
Study Oversight
Has Oversight DMC:
False
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?: