The Prescriptive Validity of a Novel Fall Risk Clinical Prediction Rule for People With COPD

NCT05173532 | Unknown

• 1 other identifier: IRB-FY2021-1
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 4

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• 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"

  4 weeks

• 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"

  8 weeks

Secondary Outcomes (2)

• Global Rating of Change in Balance after 4 weeks

  4 weeks

• Global Rating of Change in Balance after 8 weeks

  8 weeks

Study Arms (2)

Balance Training

EXPERIMENTAL

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.

Other: Balance Training

Breathing and Stretching Exercises

ACTIVE COMPARATOR

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.

Other: Breathing and Stretching Exercises

Interventions

Balance Training OTHER

static and dynamic balance and gait stability exercises

Balance Training

Breathing and Stretching Exercises OTHER

static stretching while performing diaphragmatic breathing

Breathing and Stretching Exercises

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Texas Woman's University: lead

Study Sites (4)

Breathing Center of Houston

Houston, Texas, 77077, United States

Location

Breathing Center of Houston

Houston, Texas, 77081, United States

Location

Breathing Center of Houston

Sugar Land, Texas, 77479, United States

Location

Breathing Center of Houston

Webster, Texas, 77598, United States

Location

Related Publications (33)

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MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Respiration

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Respiratory Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena

Study Officials

• Christopher A Brown, PT, DPT

  Texas Woman's University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 19, 2021
• First Posted: December 30, 2021
• Study Start: February 10, 2021
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: April 27, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)