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Completed

NCT Number: NCT05972239

Balance Training in Chronic Obstructive Pulmonary Disease

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.

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Key information

Age range

80 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of pulmonary rehabilitation

Tradate, Varese, 21049, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Standard pulmonary rehabilitation program

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.

Balance training added on standard pulmonary rehabilitation

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.

Primary outcomes

  1. Balance

    Time frame: 3 weeks

    Berg Balance Scale (BBS). Scores range from 0 (worst) - 4 (best).

Secondary outcomes

  1. Peripheral muscle strenght

    Time frame: 3 weeks

    Five sit to stand test (5STS). Time < 14.9 seconds (best), >14.8 seconds (worst).

  2. Gait speed

    Time frame: 3 weeks

    4-meter gait speed test (4MGS). Time < 4.83 seconds (best), >4.82 seconds (worst).

  3. Health status

    Time frame: 3 weeks

    The COPD Assessment Test (CAT) score ranges from 0 (best) to 40 (worst).

  4. Dyspnea

    Time frame: 3 weeks

    Medical Research Council (mMRC) score ranges from 0 (best) to 4 (worst).

  5. Dyspnea on daily life activities

    Time frame: 3 weeks

    Barthel Dyspnea Index (BDI) total score ranges from 0 (best) to 100 (worst).

  6. COPD Quality of life

    Time frame: 3 weeks

    EuroQoL-5D total score ranges from 0 (worst) to 100 (best).

  7. Exercise capacity

    Time frame: 3 weeks

    Six-Minute Walking Test (6MWT) measures the maximum walked distance in meters (m) in a given time (6 minutes).

  8. Confidence with balance

    Time frame: 3 weeks

    Activities-specific Balance Confidence short form (ABC-6) Scale. Score from 0 (worst) to 100 (best).

  9. Perceived change

    Time frame: 3 weeks

    Global perceived effect (GPE) scale. Score range from 1 (best) to 7 (worst).

Sponsors and collaborators

Lead sponsor

Istituti Clinici Scientifici Maugeri SpA

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
Aug 2, 2023
Registry last updated
Apr 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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