RecruitingNot ApplicableNCT05972239

Balance Training in Chronic Obstructive Pulmonary Disease

Balance Training: Its Effect on Pulmonary Rehabilitation of Elderly Subjects With Chronic Obstructive Pulmonary Disease

Sponsor

Istituti Clinici Scientifici Maugeri SpA

Enrollment

50 participants

Start Date

May 1, 2023

Study Type

INTERVENTIONAL

Conditions

COPD

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.

Eligibility

Min Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study is evaluating whether a structured balance training program improves stability, reduces fall risk, and helps with breathing and quality of life in people aged 80 and older who have chronic obstructive pulmonary disease (COPD). COPD is a lung disease that makes it hard to breathe, and older patients with COPD are at increased risk of falling. This study tests whether specific balance exercises — as part of pulmonary rehabilitation — can help. **You may be eligible if...** - You are 80 years old or older - You have a confirmed diagnosis of COPD (with a lung function test showing Tiffeneau Index below 70%) - You are receiving optimized medical treatment for your COPD - You are able to complete the study procedures, including exercise testing **You may NOT be eligible if...** - You have significant cognitive impairment (Mini-Mental State Examination score below 22) - You have a high burden of anticholinergic medications that can affect thinking and balance (score ≥ 3) - You have a brain lesion, inner ear condition, or significant visual impairment - You have had lower limb surgery in the past 6 months - You have any acute or chronic condition that would prevent safe exercise participation Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERStandard pulmonary rehabilitation program

Educational interventions, 3 individual sessions of 10-20 minutes and 1 weekly group meeting of 45-60 minutes on nutrition and on the emotional management of the disease. Supervised and incremental aerobic training, lasting at least 30 minutes, 5/6 days a week for a total of 12-14 sessions. The initial workload will be set between 50-70% of the maximum load (watts) determined starting from the 6MWT using the Hill equation and will be increased to reach a perception of moderate-intense fatigue and/or dyspnea. Supervised strength training of the lower limbs and upper limbs, lasting 30 minutes, 5/6 times a week for a total of 12-14 sessions. The workload will be calibrated to allow the execution of 12 consecutive repetitions and will be progressively increased by 0.5 kg in order to cause a moderate/intense fatigue and/or dyspnea. Group exercises aimed at improving flexibility of the trunk, lower and upper limbs, lasting at least 30 minutes, 5/6 days a week, for a total of 12-14 sessions.

OTHERBalance training added on standard pulmonary rehabilitation

Educational interventions, 3 individual sessions of 10-20 minutes and 1 weekly group meeting of 45-60 minutes on nutrition and on the emotional management of the disease. Supervised and incremental aerobic training, lasting at least 30 minutes, 5/6 days a week for a total of 12-14 sessions. The initial workload will be set between 50-70% of the maximum load determined from the 6MWT (Hill equation) and will be increased based on dyspnea. Supervised strength training of the lower limbs and upper limbs, lasting 30 minutes, 5/6 times a week for a total of 12-14 sessions. The workload will be progressively increased. Supervised balance training sessions lasting 30 minutes, 5/6 times a week for a total of 12-14 sessions. The sequence of the exercises will be personalized according to the result of the Berg Balance Scale and modified according to the progress.