COPDNCT05972239
Balance Training in Chronic Obstructive Pulmonary Disease
A study testing Standard pulmonary rehabilitation program and Balance training added on standard pulmonary rehabilitation in people with COPD, run by Istituti Clinici Scientifici Maugeri SpA at 1 site in Italy.
Trial 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). Read more about this study
- Who is it for?
- Ages 80 years and older
- Conditions the study is for
- COPD
- What is being tested?
- Standard pulmonary rehabilitation program and Balance training added on standard pulmonary rehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteItaly
- Study dates
- 1 May 2023to 19 Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 80 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Balance Training: Its Effect on Pulmonary Rehabilitation of Elderly Subjects With 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.
Read the 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
- Being tested
- Standard pulmonary rehabilitation program, Balance training added on standard pulmonary rehabilitation
- Keywords
- Exercise, Rehabilitation, Aged, postural balance
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard pulmonary rehabilitation programOther
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 rehabilitationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | Educational interventions, aerobic and strenght training, flexibility exercises. Receives: Other: Standard pulmonary rehabilitation program |
| Intervention | Experimental | Educational interventions, aerobic and strenght training, balance training. Receives: Other: Balance training added on standard pulmonary rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Balance
Berg Balance Scale (BBS). Scores range from 0 (worst) - 4 (best).
Measured: 3 weeks
Secondary outcomes (9)
Peripheral muscle strenght
Five sit to stand test (5STS). Time < 14.9 seconds (best), >14.8 seconds (worst).
Measured: 3 weeks
Gait speed
4-meter gait speed test (4MGS). Time < 4.83 seconds (best), >4.82 seconds (worst).
Measured: 3 weeks
Health status
The COPD Assessment Test (CAT) score ranges from 0 (best) to 40 (worst).
Measured: 3 weeks
Dyspnea
Medical Research Council (mMRC) score ranges from 0 (best) to 4 (worst).
Measured: 3 weeks
Dyspnea on daily life activities
Barthel Dyspnea Index (BDI) total score ranges from 0 (best) to 100 (worst).
Measured: 3 weeks
COPD Quality of life
EuroQoL-5D total score ranges from 0 (worst) to 100 (best).
Measured: 3 weeks
Exercise capacity
Six-Minute Walking Test (6MWT) measures the maximum walked distance in meters (m) in a given time (6 minutes).
Measured: 3 weeks
Confidence with balance
Activities-specific Balance Confidence short form (ABC-6) Scale. Score from 0 (worst) to 100 (best).
Measured: 3 weeks
Perceived change
Global perceived effect (GPE) scale. Score range from 1 (best) to 7 (worst).
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2023
- Study start1 May 2023
- Primary completion15 Jan 2025
- Study completion19 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituti Clinici Scientifici Maugeri SpA
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05972239
- Sponsor's protocol ID
- 2763
- Status last verified
- Apr 2026
- First submitted
- 23 May 2023
- Last updated
- 17 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Balance Training: Its Effect on Pulmonary Rehabilitation of Elderly Subjects With Chronic Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT05972239
- Acronym / sponsor ID
- 2763
- Conditions
- COPD
- Keywords
- Exercise, Rehabilitation, Aged, postural balance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Istituti Clinici Scientifici Maugeri SpAUniversity, hospital or other
- Study start
- 1 May 2023 (actual)
- Primary completion
- 15 Jan 2025 (actual)
- Study completion
- 19 Jan 2026 (actual)
- First posted
- 2 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Other: Standard pulmonary rehabilitation programEducational interventions, aerobic and strenght training, flexibility exercises. |
| Intervention | Experimental | Other: Balance training added on standard pulmonary rehabilitationEducational interventions, aerobic and strenght training, balance training. |
Who may qualify
- Ages
- 80 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard pulmonary rehabilitation programEducational 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. | Other | Control |
| Balance training added on standard pulmonary rehabilitationEducational 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. | Other | Intervention |
Primary outcome
Balance
Time frame: 3 weeks
Berg Balance Scale (BBS). Scores range from 0 (worst) - 4 (best).
9 secondary outcomes
Peripheral muscle strenght
Time frame: 3 weeks
Gait speed
Time frame: 3 weeks
Health status
Time frame: 3 weeks
Dyspnea
Time frame: 3 weeks
Dyspnea on daily life activities
Time frame: 3 weeks
COPD Quality of life
Time frame: 3 weeks
Exercise capacity
Time frame: 3 weeks
Confidence with balance
Time frame: 3 weeks
Perceived change
Time frame: 3 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard pulmonary rehabilitation program and Balance training added on standard pulmonary rehabilitation in people with COPD, run by Istituti Clinici Scientifici Maugeri SpA at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Balance (time frame: 3 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2026.