Balance Training in Chronic Obstructive Pulmonary Disease

Not Applicable

Recruiting

• Conditions: COPD
• Interventions: Other: Balance training added on standard pulmonary rehabilitation; Other: Standard pulmonary rehabilitation program

• Registration Number: NCT05972239
• Lead Sponsor: Istituti Clinici Scientifici Maugeri SpA

Brief Summary

The aim of the study will be to verify whether the addition of an exercise program aimed to improve balance can reduce the risk of falling in subjects with COPD over 80 years of age compared to the standard rehabilitation program. Patients will be randomly assigned in two groups (intervention and control). The pulmonary rehabilitation (PR) program is organized in accordance with current guidelines.

Detailed Description

Chronic Obstructive Pulmonary Disease-COPD is the most prevalent pathology among chronic airway diseases. The average age of life has increased. Subjects over 80 years old have peculiar characteristics. Individuals with COPD have an increased risk of falling compared with healthy peers. A pulmonary rehabilitation program reduces the risk of falling as measured by gait speed. Balance training on the elderly has been shown to be effective in improving muscle strength, coordination, balance and in reducing the risk and number of falls and the fear of falling.

The enrolled subjects will complete an in-patient PR program according to enrollment.

Control: education, aerobic and strength training and callisthenic exercises. Intervention: education, aerobic and strength training as group Control and balance training. At baseline will be recorded: demographics and anthropometrics, comorbidities, drug therapy, flow/volume curve, arterial blood gases, serum hemoglobin, history of fall, exacerbations and risk of sarcopenia. Before and after the PR the following outcome measures will be assessed: balance performance, peripheral muscle strength, gait speed, health status, dyspnea, quality of life, exercise capacity, confidence with balance and perceived change. Sample size calculation was performed based on the primary endpoint of the study. We estimate a number of 50 subjects.

Study Timeline

• Study Start: 2023-05-01
• Study First Submitted: 2023-05-23
• Study First Submitted QC: 2023-07-25
• Study First Posted: 2023-08-02
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-04
• Last Update Posted: 2024-10-08
• Primary Completion: 2025-12-31
• Study Completion: 2026-03-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Age ≥ 80 years old,
• Diagnosis of COPD according to GOLD Guidelines (Tiffenau Index <70%) under optimized medical treatment,
• Able to perform and complete study procedures.

Exclusion Criteria

• Anticholinergic Cognitive Burden score ≥3,
• Mini-Mental State Examination <22,
• Acute or chronic impairment and/or medical diseases that are likely to preclude exercise testing and PR.
• Brain lesions,
• Inner ear disease
• Visual deficit,
• Lower limb surgery in the previous 6 months.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	Balance training added on standard pulmonary rehabilitation	Educational interventions, aerobic and strenght training, balance training.
Control	Standard pulmonary rehabilitation program	Educational interventions, aerobic and strenght training, flexibility exercises.

Primary Outcome Measures

Name	Time	Method
Balance	3 weeks	Berg Balance Scale (BBS). Scores range from 0 (worst) - 4 (best).

Secondary Outcome Measures

Name	Time	Method
Gait speed	3 weeks	4-meter gait speed test (4MGS). Time \< 4.83 seconds (best), \>4.82 seconds (worst).
Peripheral muscle strenght	3 weeks	Five sit to stand test (5STS). Time \< 14.9 seconds (best), \>14.8 seconds (worst).
Dyspnea on daily life activities	3 weeks	Barthel Dyspnea Index (BDI) total score ranges from 0 (best) to 100 (worst).
Confidence with balance	3 weeks	Activities-specific Balance Confidence short form (ABC-6) Scale. Score from 0 (worst) to 100 (best).
Health status	3 weeks	The COPD Assessment Test (CAT) score ranges from 0 (best) to 40 (worst).
Dyspnea	3 weeks	Medical Research Council (mMRC) score ranges from 0 (best) to 4 (worst).
COPD Quality of life	3 weeks	EuroQoL-5D total score ranges from 0 (worst) to 100 (best).
Exercise capacity	3 weeks	Six-Minute Walking Test (6MWT) measures the maximum walked distance in meters (m) in a given time (6 minutes).
Perceived change	3 weeks	Global perceived effect (GPE) scale. Score range from 1 (best) to 7 (worst).

Trial Locations

Locations (1)

Department of pulmonary rehabilitation; 🇮🇹 Tradate, Varese, Italy