Balance Training in Chronic Obstructive Pulmonary Disease

Istituti Clinici Scientifici Maugeri SpA

Status: Enrolling

Conditions: COPD

Treatments: Other: Standard pulmonary rehabilitation program; Other: Balance training added on standard pulmonary rehabilitation

Study type: Interventional

Funder types: Other

Identifiers

NCT05972239

2763

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 80+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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50 participants in 2 patient groups

Control

Active Comparator group

Description:

Educational interventions, aerobic and strenght training, flexibility exercises.

Treatment:

Other: Standard pulmonary rehabilitation program

Intervention

Experimental group

Description:

Educational interventions, aerobic and strenght training, balance training.

Treatment:

Other: Balance training added on standard pulmonary rehabilitation