Ignite Creation Date:
2025-12-24 @ 3:01 PM
Ignite Modification Date:
2025-12-26 @ 2:34 AM
Study NCT ID:
NCT01411059
Status:
COMPLETED
Last Update Posted:
2016-11-16
First Post:
2011-07-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Yoga Empowers Seniors Study
Sponsor:
University of Southern California
Organization:
Study Overview
Official Title:
Safe and Effective Yoga Prescription of Seniors: Biomechanical Considerations
Status:
COMPLETED
Status Verified Date:
2016-11
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:
YESS
Brief Summary:
This is an Intervention Development Study (IDS) to quantify the physical demands (using biomechanical investigation) of a 2-phase (beginning \& intermediate), 32-week yoga program designed for community-dwelling older adults. Additionally, the IDS will explore the adherence and adverse events of participation in the program. Data from the IDS will be used to develop evidenced-based yoga programs, which the investigators postulate will be associated with fewer musculoskeletal side effects compared to non-evidence based yoga programs. The investigators also postulate that evidenced-based tailoring of yoga for seniors will enhance adherence and efficacy. The programs developed during this IDS will be tested in an expanded, Phase II, Randomized Controlled Trial.
Detailed Description:
Yoga is currently being recommended to restore and preserve strength, flexibility, balance, \& physical capacity in older adults; however, our clinical trial experiences suggest that without proper evidenced-based prescription, Yoga participation can be ineffective or even injurious for seniors. To address this lack of evidence-based knowledge, the proposed IDS will: 1) quantify the physical demands of a 32-wk Yoga program designed for independent ambulatory seniors; 2) characterize the relations between these demands and participant physical characteristics; 3) examine the adherence, efficacy, \& safety of the program; and 4) characterize the relations among reported adverse events, baseline participant characteristics, and Yoga physical demands.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: