NCT05501457

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
45

participants targeted

Target at P25-P50 for not_applicable quality-of-life

Timeline
Completed

Started Jul 2022

Shorter than P25 for not_applicable quality-of-life

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 15, 2022

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

August 9, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 15, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2022

Completed
Last Updated

August 15, 2022

Status Verified

August 1, 2022

Enrollment Period

3 months

First QC Date

August 9, 2022

Last Update Submit

August 11, 2022

Conditions

Keywords

COPDPulmonary rehabilitationNeuromuscular electrical stimulation

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Modified Borg Scale (MBS):

    4 weeks

  • St. George's Respiratory Questionnaire (SGRQ):

    4 weeks

  • Beck Depression Inventory (BDI):

    4 weeks

Study Arms (3)

The gastrocnemius group

EXPERIMENTAL

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 quadriceps femoris group

EXPERIMENTAL

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 control group

EXPERIMENTAL

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

Device: Muscle strengthening with neuromuscular electrical stimulation

Interventions

The effect of peripheral muscle strengthening training in addition to pulmonary rehabilitation in COPD patients on the patient's performance will be examined.

The control groupThe gastrocnemius groupThe quadriceps femoris group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hititi University Sungurlu Vocational School

Çorum, 19000, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Anxiety DisordersPulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Mental DisordersLung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Ahmet Payas, Dr

    HİTİT UNIVERSITY CORUM EROL OLCOK EDUCATION AND RESEARCH HOSPITAL

    STUDY DIRECTOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

August 9, 2022

First Posted

August 15, 2022

Study Start

July 15, 2022

Primary Completion

October 1, 2022

Study Completion

November 1, 2022

Last Updated

August 15, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

A short summary of the study can be shared.

Locations