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

Comparison of the Effects of Quadriceps and Gastrocnemius Muscle Training on Activities of Daily Living in COPD

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.

Study Overview

• Status: Recruiting
• Conditions: Quality of Life; Anxiety
• Intervention / Treatment: Device: Muscle strengthening with neuromuscular electrical stimulation

• Study Type: Interventional
• Enrollment (Anticipated): 45
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ahmet Payas, Dr; Phone Number: 05343483399; Email: ahmetpayas@hitit.edu.tr

Study Locations

• Turkey
  • Corum, Turkey, 19000
    • Recruiting
    • Hititi University Sungurlu Vocational School
    • Contact: Ahmet Payas; Phone Number: 05343483399; Email: ahmetpayas@hitit.edu.tr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: The gastrocnemius group; 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,	Device: Muscle strengthening with neuromuscular electrical stimulation; The effect of peripheral muscle strengthening training in addition to pulmonary rehabilitation in COPD patients on the patient's performance will be examined.
Experimental: The quadriceps femoris group; 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),	Device: Muscle strengthening with neuromuscular electrical stimulation; The effect of peripheral muscle strengthening training in addition to pulmonary rehabilitation in COPD patients on the patient's performance will be examined.
Experimental: The control group; The third group, which was the control group, was given only a pulmonary rehabilitation program (Group 3).	Device: Muscle strengthening with neuromuscular electrical stimulation; The effect of peripheral muscle strengthening training in addition to pulmonary rehabilitation in COPD patients on the patient's performance will be examined.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	4 weeks
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.	4 weeks
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.	4 weeks

Collaborators and Investigators

• Sponsor: Hitit University
• Investigators: Study Director: Ahmet Payas, Dr, HİTİT UNIVERSITY CORUM EROL OLCOK EDUCATION AND RESEARCH HOSPITAL

Study record dates

Study Major Dates

• Study Start (Actual): July 15, 2022
• Primary Completion (Anticipated): October 1, 2022
• Study Completion (Anticipated): November 1, 2022

Study Registration Dates

• First Submitted: August 9, 2022
• First Submitted That Met QC Criteria: August 11, 2022
• First Posted (Actual): August 15, 2022

Study Record Updates

• Last Update Posted (Actual): August 15, 2022
• Last Update Submitted That Met QC Criteria: August 11, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: COPD; Pulmonary rehabilitation; Neuromuscular electrical stimulation
• Other Study ID Numbers: HititUApayas

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: A short summary of the study can be shared.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No