Clinical trial NCT05972239: Balance Training in Chronic Obstructive Pulmonary Disease
Official title: Balance Training: Its Effect on Pulmonary Rehabilitation of Elderly Subjects With Chronic Obstructive Pulmonary Disease
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: COPD
Keywords: Exercise
Rehabilitation
Aged
postural balance
Lead sponsor: Istituti Clinici Scientifici Maugeri SpA
Sponsor class: OTHER
First posted: 2023-08-02
Enrollment: 50
Sex: ALL
Minimum age (years): 80
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Balance
timeFrame: 3 weeks
Secondary outcomes:
measure: Peripheral muscle strenght
timeFrame: 3 weeks
measure: Gait speed
timeFrame: 3 weeks
measure: Health status
timeFrame: 3 weeks
measure: Dyspnea
timeFrame: 3 weeks
measure: Dyspnea on daily life activities
timeFrame: 3 weeks
measure: COPD Quality of life
timeFrame: 3 weeks
measure: Exercise capacity
timeFrame: 3 weeks
measure: Confidence with balance
timeFrame: 3 weeks
measure: Perceived change
timeFrame: 3 weeks
Other outcomes:
Locations:
city: Tradate
country: Italy
facility: Department of pulmonary rehabilitation
state: Varese
Study officials:
References: