Balance Training in Chronic Obstructive Pulmonary Disease

COPD Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05972239
• Other study ID #: 2763
• Status: Recruiting
• Phase: N/A
• Start date: May 1, 2023
• Est. completion date: September 30, 2024

Study information

• Verified date: July 2023
• Source: Istituti Clinici Scientifici Maugeri SpA
• Contact: Elisabetta Zampogna, dr
• Phone: 3335442246
• Email: elisabetta.zampogna[@]icsmaugeri.it
• Is FDA regulated: No
• Study type: Interventional

Clinical 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). The pulmonary rehabilitation (PR) program is organized in accordance with current guidelines.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: September 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 80 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• COPD
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Other:
• 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.
• 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.

Locations

Country	Name	City	State
Italy	Department of pulmonary rehabilitation	Tradate	Varese

Sponsors (1)

Lead Sponsor	Collaborator
Istituti Clinici Scientifici Maugeri SpA

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Balance	Berg Balance Scale (BBS). Scores range from 0 (worst) - 4 (best).	3 weeks
Secondary	Peripheral muscle strenght	Five sit to stand test (5STS). Time < 14.9 seconds (best), >14.8 seconds (worst).	3 weeks
Secondary	Gait speed	4-meter gait speed test (4MGS). Time < 4.83 seconds (best), >4.82 seconds (worst).	3 weeks
Secondary	Health status	The COPD Assessment Test (CAT) score ranges from 0 (best) to 40 (worst).	3 weeks
Secondary	Dyspnea	Medical Research Council (mMRC) score ranges from 0 (best) to 4 (worst).	3 weeks
Secondary	Dyspnea on daily life activities	Barthel Dyspnea Index (BDI) total score ranges from 0 (best) to 100 (worst).	3 weeks
Secondary	COPD Quality of life	EuroQoL-5D total score ranges from 0 (worst) to 100 (best).	3 weeks
Secondary	Exercise capacity	Six-Minute Walking Test (6MWT) measures the maximum walked distance in meters (m) in a given time (6 minutes).	3 weeks
Secondary	Confidence with balance	Activities-specific Balance Confidence short form (ABC-6) Scale. Score from 0 (worst) to 100 (best).	3 weeks
Secondary	Perceived change	Global perceived effect (GPE) scale. Score range from 1 (best) to 7 (worst).	3 weeks