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The Effect of Different Muscle Training on Activities of Daily Living in COPD

Primary Purpose

Quality of Life, Anxiety

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Muscle strengthening with neuromuscular electrical stimulation
Sponsored by
Hitit University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Quality of Life focused on measuring COPD, Pulmonary rehabilitation, Neuromuscular electrical stimulation

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Being between 18-75 years old,
  • Diagnosed as group B stable COPD according to GOLD criteria by a pulmonologist,
  • PaO2 >55 mm Hg, PaCO2 <45 mmHg in room air.

Exclusion Criteria:

  • Exacerbation,
  • Cor pulmonale or respiratory muscle fatigue (abdominal paradoxical breathing),
  • Cardiac instability (with acute MI, congestive heart failure, or uncontrollable arrhythmia),
  • Musculoskeletal disorder (conditions affecting exercise ability),
  • Difficulty communicating.

Sites / Locations

  • Hititi University Sungurlu Vocational SchoolRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

The gastrocnemius group

The quadriceps femoris group

The control group

Arm Description

The patients in the first group (n=15) were given a pulmonary rehabilitation program and additionally 20 minutes of Neuromuscular electrical stimulation (Group 1) to the gastrocnemius muscle,

The second group was given a pulmonary rehabilitation program and an additionally 20 minutes of neuromuscular electrical stimulation to the quadriceps femoris muscle (Group 2),

The third group, which was the control group, was given only a pulmonary rehabilitation program (Group 3).

Outcomes

Primary Outcome Measures

6 Minute Walk Test (6 MWT):
they could walk for 6 minutes, according to heart rate, blood pressure, respiratory rate, finger oxygen saturation, the walking distance at the end of walking, and dyspnea score according to the Modified Borg Scale (MBS) at the beginning and end of walking was recorded. Change from baseline 6 Minute walking performance after 4 weeks will be examined.

Secondary Outcome Measures

Modified Borg Scale (MBS):
It consists of 10 items that define the severity of dyspnea according to their degrees. Change from baseline dyspnea after 4 weeks will be examined.
St. George's Respiratory Questionnaire (SGRQ):
This questionnaire was developed specifically to determine the severity of the disease in COPD and asthma. Change from baseline severity of the disease after 4 weeks will be examined.
Beck Depression Inventory (BDI):
It measures the behavioral findings of depression in adolescents and adults. Change from baseline depression status after 4 weeks will be examined.

Full Information

First Posted
August 9, 2022
Last Updated
August 11, 2022
Sponsor
Hitit University
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1. Study Identification

Unique Protocol Identification Number
NCT05501457
Brief Title
The Effect of Different Muscle Training on Activities of Daily Living in COPD
Official Title
Comparison of the Effects of Quadriceps and Gastrocnemius Muscle Training on Activities of Daily Living in COPD
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 15, 2022 (Actual)
Primary Completion Date
October 1, 2022 (Anticipated)
Study Completion Date
November 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hitit University

4. Oversight

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

5. Study Description

Brief Summary
Chronic obstructive pulmonary disease (COPD) contributes significantly to global morbidity and mortality; It is a disease that affects an estimated 210 million people worldwide and is the third most common cause of death. COPD is identified by persistent airflow limitation and is associated with progressively worsening lung function, dyspnea, health-related quality of life (HRQOL), and impaired exercise capacity. Poor exercise capacity is a common finding of chronic obstructive pulmonary disease (COPD). Central cardiopulmonary factors, respiratory muscle dysfunction, gas exchange abnormalities, and skeletal muscle dysfunction all play a role in limiting exercise capacity The aim of this study is to investigate the effects of neuromuscular electrical stimulation applied to different muscle groups (quadriceps femoris and gastrocnemius muscles) on exercise performance and quality of life in patients with stable COPD and compare it with standard treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Quality of Life, Anxiety
Keywords
COPD, Pulmonary rehabilitation, Neuromuscular electrical stimulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
45 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
The gastrocnemius group
Arm Type
Experimental
Arm Description
The patients in the first group (n=15) were given a pulmonary rehabilitation program and additionally 20 minutes of Neuromuscular electrical stimulation (Group 1) to the gastrocnemius muscle,
Arm Title
The quadriceps femoris group
Arm Type
Experimental
Arm Description
The second group was given a pulmonary rehabilitation program and an additionally 20 minutes of neuromuscular electrical stimulation to the quadriceps femoris muscle (Group 2),
Arm Title
The control group
Arm Type
Experimental
Arm Description
The third group, which was the control group, was given only a pulmonary rehabilitation program (Group 3).
Intervention Type
Device
Intervention Name(s)
Muscle strengthening with neuromuscular electrical stimulation
Intervention Description
The effect of peripheral muscle strengthening training in addition to pulmonary rehabilitation in COPD patients on the patient's performance will be examined.
Primary Outcome Measure Information:
Title
6 Minute Walk Test (6 MWT):
Description
they could walk for 6 minutes, according to heart rate, blood pressure, respiratory rate, finger oxygen saturation, the walking distance at the end of walking, and dyspnea score according to the Modified Borg Scale (MBS) at the beginning and end of walking was recorded. Change from baseline 6 Minute walking performance after 4 weeks will be examined.
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Modified Borg Scale (MBS):
Description
It consists of 10 items that define the severity of dyspnea according to their degrees. Change from baseline dyspnea after 4 weeks will be examined.
Time Frame
4 weeks
Title
St. George's Respiratory Questionnaire (SGRQ):
Description
This questionnaire was developed specifically to determine the severity of the disease in COPD and asthma. Change from baseline severity of the disease after 4 weeks will be examined.
Time Frame
4 weeks
Title
Beck Depression Inventory (BDI):
Description
It measures the behavioral findings of depression in adolescents and adults. Change from baseline depression status after 4 weeks will be examined.
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Being between 18-75 years old, Diagnosed as group B stable COPD according to GOLD criteria by a pulmonologist, PaO2 >55 mm Hg, PaCO2 <45 mmHg in room air. Exclusion Criteria: Exacerbation, Cor pulmonale or respiratory muscle fatigue (abdominal paradoxical breathing), Cardiac instability (with acute MI, congestive heart failure, or uncontrollable arrhythmia), Musculoskeletal disorder (conditions affecting exercise ability), Difficulty communicating.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ahmet Payas, Dr
Phone
05343483399
Email
ahmetpayas@hitit.edu.tr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ahmet Payas, Dr
Organizational Affiliation
HİTİT UNIVERSITY CORUM EROL OLCOK EDUCATION AND RESEARCH HOSPITAL
Official's Role
Study Director
Facility Information:
Facility Name
Hititi University Sungurlu Vocational School
City
Corum
ZIP/Postal Code
19000
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ahmet Payas
Phone
05343483399
Email
ahmetpayas@hitit.edu.tr

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
A short summary of the study can be shared.

Learn more about this trial

The Effect of Different Muscle Training on Activities of Daily Living in COPD

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