Ignite Creation Date:
2025-12-24 @ 9:24 PM
Ignite Modification Date:
2025-12-24 @ 9:24 PM
Study NCT ID:
NCT05173532
Status:
UNKNOWN
Last Update Posted:
2022-04-27
First Post:
2021-02-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Prescriptive Validity of a Novel Fall Risk Clinical Prediction Rule for People With COPD
Sponsor:
Texas Woman's University
Organization:
Study Overview
Official Title:
The Prescriptive Validity of a Novel Fall Risk Clinical Prediction Rule for People With COPD
Status:
UNKNOWN
Status Verified Date:
2022-04
Last Known Status:
ACTIVE_NOT_RECRUITING
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 study has 3 objectives: (1) demonstrate the effectiveness of balance training for people with COPD, (2) determine which patients with COPD respond best to balance training, and (3) calculate clinically meaningful changes in balance for patients with COPD.
Detailed Description:
After receiving a detailed explanation of the study, including its risks and benefits, and providing informed consent, patients will be screened for eligibility criteria during a single 75-minute evaluation for participation in a physical therapy based pulmonary rehabilitation program. Those meeting eligibility criteria will be randomly assigned in blocks of four (by clinical site) in a single-blind manner (patients) in a 1:1 ratio to either balance training or a breathing and stretching exercise program. Both groups will receive respiratory muscle stretch exercises, aerobic exercise, strength training, and fall prevention education. The intervention phase will last 8 weeks, with patients being seen 3 times per week for 75 minute sessions supervised by a physical therapist or physical therapist assistant.
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?: