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

Texas Woman's University

Status: Unknown

Conditions: Pulmonary Disease, Chronic Obstructive

Treatments: Other: Breathing and Stretching Exercises; Other: Balance Training

Study type: Interventional

Funder types: Other

Identifiers

NCT05173532

IRB-FY2021-1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 88 patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

88 participants in 2 patient groups

Balance Training

Experimental group

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.

Treatment:

Other: Balance Training

Breathing and Stretching Exercises

Active Comparator group

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.

Treatment:

Other: Breathing and Stretching Exercises