Back to resultsThe Prescriptive Validity of a Novel Fall Risk Clinical Prediction Rule for People With COPD
Primary Purpose
Pulmonary Disease, Chronic Obstructive
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Balance Training
Breathing and Stretching Exercises
Sponsored by
About this trial
This is an interventional treatment trial for Pulmonary Disease, Chronic Obstructive focused on measuring Balance, Falls, Fall Risk, Aerobic Exercise, Strength Training, Fall Prevention, Stretching Exercise, Breathing Exercise, Randomized Controlled Trial, Clinical Prediction Rule, Minimal Clinically Important Difference
Eligibility Criteria
Inclusion Criteria:
- having reported a fall in the past 5 years, or a near fall in the past year, or a score ≥ 9 on the Short Version of the Falls Efficacy Scale - International Version
- age ≥ 60 years
- both sexes
- spirometrically-confirmed COPD of all disease severity stages
- being independently ambulatory with or without a gait aid
- medical clearance by a physician to participate in pulmonary rehabilitation
- provision of informed consent.
Exclusion Criteria:
- having suffered a recent, severe COPD exacerbation (recent is 30 days or less prior to the study baseline)
- participation in a formal exercise program in the three months prior to the study baseline
- an inability by the patient to complete all study testing due to physical, psychological, communication-barrier, or other unanticipated reasons.
Sites / Locations
- Breathing Center of Houston
- Breathing Center of Houston
- Breathing Center of Houston
- Breathing Center of Houston
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Balance Training
Breathing and Stretching Exercises
Arm Description
Static and dynamic balance and gait stability training exercises are performed with supervision by a physical therapist or physical therapist assistant for 30 minutes, 3 times per week, for 8 weeks.
Patients perform static stretches for all major muscle groups while performing diaphragmatic breathing with supervision by a physical therapist or physical therapist assistant for 30 minutes, 3 times per week, for 8 weeks.
Outcomes
Primary Outcome Measures
Change in Brief Balance Evaluation Systems Test total score baseline to 4 weeks
8-item balance test battery, each item rated from 0-3 then summed for total score, items #3 and #4 are tested on both the right and left side. (#1) HIP/TRUNK LATERAL STRENGTH, (#2) FUNCTIONAL REACH FORWARD, (#3) SINGLE-LEG STANCE, (#4) COMPENSATORY STEPPING CORRECTION- LATERAL, (#5) STAND ON FOAM, EYES CLOSED: (3) 30s stable (2) 30s unstable (1) < 30s (0) Unable, (#6) TIMED "GET UP & GO"
Change in Brief Balance Evaluation Systems Test total score baseline to 8 weeks
8-item balance test battery, each item rated from 0-3, then summed for total score, items #3 and #4 are tested on both the right and left side. (#1) HIP/TRUNK LATERAL STRENGTH, (#2) FUNCTIONAL REACH FORWARD, (#3) SINGLE-LEG STANCE, (#4) COMPENSATORY STEPPING CORRECTION- LATERAL, (#5) STAND ON FOAM, EYES CLOSED: (3) 30s stable (2) 30s unstable (1) < 30s (0) Unable, (#6) TIMED "GET UP & GO"
Secondary Outcome Measures
Global Rating of Change in Balance after 4 weeks
11-point self-report outcome rating balance improvement(+) or decline(-). Ratings: (+/-5)="very large", (+/-4)="large", (+/-3)="medium", (+/-2)="small", (+/-1)="very small", (0)="none"
Global Rating of Change in Balance after 8 weeks
11-point self-report outcome rating balance improvement(+) or decline(-). Ratings: (+/-5)="very large", (+/-4)="large", (+/-3)="medium", (+/-2)="small", (+/-1)="very small", (0)="none"
Full Information
NCT ID
NCT05173532
First Posted
February 19, 2021
Last Updated
April 26, 2022
Sponsor
Texas Woman's University
1. Study Identification
Unique Protocol Identification Number
NCT05173532
Brief Title
The Prescriptive Validity of a Novel Fall Risk Clinical Prediction Rule for People With COPD
Official Title
The Prescriptive Validity of a Novel Fall Risk Clinical Prediction Rule for People With COPD
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 10, 2021 (Actual)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Texas Woman's University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Disease, Chronic Obstructive
Keywords
Balance, Falls, Fall Risk, Aerobic Exercise, Strength Training, Fall Prevention, Stretching Exercise, Breathing Exercise, Randomized Controlled Trial, Clinical Prediction Rule, Minimal Clinically Important Difference
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
The patients will be blinded to their group assignment. At the time of their group assignment, they will be told that they are in either group "A" (which is actually the experimental group receiving balance training) or "B" (which is actually the active control group receiving the breathing and stretching exercise program), and that both groups may lead to better balance, neither are expected to worsen balance, and it is uncertain which one is more effective at improving balance. After their study participation, patients will guess which group they were in, then told if they guessed correctly.
Allocation
Randomized
Enrollment
88 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Balance Training
Arm Type
Experimental
Arm Description
Static and dynamic balance and gait stability training exercises are performed with supervision by a physical therapist or physical therapist assistant for 30 minutes, 3 times per week, for 8 weeks.
Arm Title
Breathing and Stretching Exercises
Arm Type
Active Comparator
Arm Description
Patients perform static stretches for all major muscle groups while performing diaphragmatic breathing with supervision by a physical therapist or physical therapist assistant for 30 minutes, 3 times per week, for 8 weeks.
Intervention Type
Other
Intervention Name(s)
Balance Training
Intervention Description
static and dynamic balance and gait stability exercises
Intervention Type
Other
Intervention Name(s)
Breathing and Stretching Exercises
Intervention Description
static stretching while performing diaphragmatic breathing
Primary Outcome Measure Information:
Title
Change in Brief Balance Evaluation Systems Test total score baseline to 4 weeks
Description
8-item balance test battery, each item rated from 0-3 then summed for total score, items #3 and #4 are tested on both the right and left side. (#1) HIP/TRUNK LATERAL STRENGTH, (#2) FUNCTIONAL REACH FORWARD, (#3) SINGLE-LEG STANCE, (#4) COMPENSATORY STEPPING CORRECTION- LATERAL, (#5) STAND ON FOAM, EYES CLOSED: (3) 30s stable (2) 30s unstable (1) < 30s (0) Unable, (#6) TIMED "GET UP & GO"
Time Frame
4 weeks
Title
Change in Brief Balance Evaluation Systems Test total score baseline to 8 weeks
Description
8-item balance test battery, each item rated from 0-3, then summed for total score, items #3 and #4 are tested on both the right and left side. (#1) HIP/TRUNK LATERAL STRENGTH, (#2) FUNCTIONAL REACH FORWARD, (#3) SINGLE-LEG STANCE, (#4) COMPENSATORY STEPPING CORRECTION- LATERAL, (#5) STAND ON FOAM, EYES CLOSED: (3) 30s stable (2) 30s unstable (1) < 30s (0) Unable, (#6) TIMED "GET UP & GO"
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Global Rating of Change in Balance after 4 weeks
Description
11-point self-report outcome rating balance improvement(+) or decline(-). Ratings: (+/-5)="very large", (+/-4)="large", (+/-3)="medium", (+/-2)="small", (+/-1)="very small", (0)="none"
Time Frame
4 weeks
Title
Global Rating of Change in Balance after 8 weeks
Description
11-point self-report outcome rating balance improvement(+) or decline(-). Ratings: (+/-5)="very large", (+/-4)="large", (+/-3)="medium", (+/-2)="small", (+/-1)="very small", (0)="none"
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
having reported a fall in the past 5 years, or a near fall in the past year, or a score ≥ 9 on the Short Version of the Falls Efficacy Scale - International Version
age ≥ 60 years
both sexes
spirometrically-confirmed COPD of all disease severity stages
being independently ambulatory with or without a gait aid
medical clearance by a physician to participate in pulmonary rehabilitation
provision of informed consent.
Exclusion Criteria:
having suffered a recent, severe COPD exacerbation (recent is 30 days or less prior to the study baseline)
participation in a formal exercise program in the three months prior to the study baseline
an inability by the patient to complete all study testing due to physical, psychological, communication-barrier, or other unanticipated reasons.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christopher A Brown, PT, DPT
Organizational Affiliation
Texas Woman's University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Breathing Center of Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77077
Country
United States
Facility Name
Breathing Center of Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77081
Country
United States
Facility Name
Breathing Center of Houston
City
Sugar Land
State/Province
Texas
ZIP/Postal Code
77479
Country
United States
Facility Name
Breathing Center of Houston
City
Webster
State/Province
Texas
ZIP/Postal Code
77598
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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The Prescriptive Validity of a Novel Fall Risk Clinical Prediction Rule for People With COPD
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