Balance Training in Chronic Obstructive Pulmonary Disease

NCT ID: NCT05972239

Last Updated: 2024-10-08

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-01
• Study Completion Date: 2026-03-30

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.

Conditions

COPD

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Control

Educational interventions, aerobic and strenght training, flexibility exercises.

Group Type: ACTIVE_COMPARATOR

Standard pulmonary rehabilitation program

Intervention Type: OTHER

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.

Intervention

Educational interventions, aerobic and strenght training, balance training.

Group Type: EXPERIMENTAL

Balance training added on standard pulmonary rehabilitation

Intervention Type: OTHER

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.

Interventions

Standard 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.

Intervention Type: OTHER

Balance 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.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Istituti Clinici Scientifici Maugeri SpA

OTHER

Sponsor Role: lead

Responsible Party

Elisabetta Zampogna

Dr

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Department of pulmonary rehabilitation

Tradate, Varese, Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Giuseppe Lo Bello, dr

Role: CONTACT

giuseppe.lobello@icsmaugeri.it

+393271623598

Antonio Spanevello, Prof

Role: CONTACT

antonio.spanevello@icsmaugeri.it

Facility Contacts

Elisabetta Zampogna, Dr

Role: primary

elisabetta.zampogna@icsmaugeri.it

+393335442246

Other Identifiers

2763

Identifier Type: -

Identifier Source: org_study_id