search
Back to results

Balance Training in Chronic Obstructive Pulmonary Disease

Primary Purpose

COPD

Status
Recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Standard pulmonary rehabilitation program
Balance training added on standard pulmonary rehabilitation
Sponsored by
Istituti Clinici Scientifici Maugeri SpA
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for COPD focused on measuring Exercise, Rehabilitation, Aged, postural balance

Eligibility Criteria

80 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Department of pulmonary rehabilitationRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Control

Intervention

Arm Description

Educational interventions, aerobic and strenght training, flexibility exercises.

Educational interventions, aerobic and strenght training, balance training.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
May 23, 2023
Last Updated
July 25, 2023
Sponsor
Istituti Clinici Scientifici Maugeri SpA
search

1. Study Identification

Unique Protocol Identification Number
NCT05972239
Brief Title
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

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 1, 2023 (Actual)
Primary Completion Date
June 30, 2024 (Anticipated)
Study Completion Date
September 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istituti Clinici Scientifici Maugeri SpA

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COPD
Keywords
Exercise, Rehabilitation, Aged, postural balance

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
Active Comparator
Arm Description
Educational interventions, aerobic and strenght training, flexibility exercises.
Arm Title
Intervention
Arm Type
Experimental
Arm Description
Educational interventions, aerobic and strenght training, balance training.
Intervention Type
Other
Intervention Name(s)
Standard pulmonary rehabilitation program
Intervention Description
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
Intervention Name(s)
Balance training added on standard pulmonary rehabilitation
Intervention Description
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 Outcome Measure Information:
Title
Balance
Description
Berg Balance Scale (BBS). Scores range from 0 (worst) - 4 (best).
Time Frame
3 weeks
Secondary Outcome Measure Information:
Title
Peripheral muscle strenght
Description
Five sit to stand test (5STS). Time < 14.9 seconds (best), >14.8 seconds (worst).
Time Frame
3 weeks
Title
Gait speed
Description
4-meter gait speed test (4MGS). Time < 4.83 seconds (best), >4.82 seconds (worst).
Time Frame
3 weeks
Title
Health status
Description
The COPD Assessment Test (CAT) score ranges from 0 (best) to 40 (worst).
Time Frame
3 weeks
Title
Dyspnea
Description
Medical Research Council (mMRC) score ranges from 0 (best) to 4 (worst).
Time Frame
3 weeks
Title
Dyspnea on daily life activities
Description
Barthel Dyspnea Index (BDI) total score ranges from 0 (best) to 100 (worst).
Time Frame
3 weeks
Title
COPD Quality of life
Description
EuroQoL-5D total score ranges from 0 (worst) to 100 (best).
Time Frame
3 weeks
Title
Exercise capacity
Description
Six-Minute Walking Test (6MWT) measures the maximum walked distance in meters (m) in a given time (6 minutes).
Time Frame
3 weeks
Title
Confidence with balance
Description
Activities-specific Balance Confidence short form (ABC-6) Scale. Score from 0 (worst) to 100 (best).
Time Frame
3 weeks
Title
Perceived change
Description
Global perceived effect (GPE) scale. Score range from 1 (best) to 7 (worst).
Time Frame
3 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Elisabetta Zampogna, dr
Phone
3335442246
Email
elisabetta.zampogna@icsmaugeri.it
First Name & Middle Initial & Last Name or Official Title & Degree
Antonio Spanevello, Prof
Email
antonio.spanevello@icsmaugeri.it
Facility Information:
Facility Name
Department of pulmonary rehabilitation
City
Tradate
State/Province
Varese
ZIP/Postal Code
21049
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elisabetta Zampogna, Dr
Phone
+393335442246
Email
elisabetta.zampogna@icsmaugeri.it

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Balance Training in Chronic Obstructive Pulmonary Disease

We'll reach out to this number within 24 hrs