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Clinical Trials/NCT02497144
NCT02497144CompletedNot Applicable

Effects of Neuromuscular Electrical Stimulation on Functional Exercise Capacity and Quality of Life in Patients With Interstitial Lung Disease

Gazi University1 site in 1 country30 target enrollmentStarted: July 15, 2015Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
30
Locations
1
Primary Endpoint
Functional exercise capacity

Study Overview

Brief Summary

Decreased exercise capacity and quality of life, increased dyspnea and fatigue perception and hypoxemia during exercise is seen in patients with interstitial lung disease. Impaired ventilatory response, increased lung compliance, ventilation-perfusion mismatching and inadequate peripheral circulation causes decreased exercise capacity. Another important factor that induce decreased exercise capacity is peripheral muscle weakness. In literature, there is no study investigated effects of neuromuscular electrical stimulation on functional exercise capacity, respiratory and peripheral muscle strength, pulmonary functions, physical activity level, dyspnea and fatigue perception in patients with interstitial lung disease.

Detailed Description

In literature, there was increased quantity of study investigated effects of neuromuscular electrical stimulation in chronic lung disease patients. It was used as a pulmonary rehabilitation component especially in patients with decreased exercise capacity and peripheral muscle strength, intensely increased dyspnea inhibits exercise. It was demonstrated that neuromuscular electrical stimulation improved functional exercise capacity, peripheral muscle strength and quality of life.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Supportive Care
Masking
Triple (Participant, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to 65 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Diagnosed with interstitial lung disease
  • •Clinically stable
  • •Under standard medication
  • •Having no exacerbation or infection

Exclusion Criteria

  • •Cognitive disorders
  • •Orthopedic and neurological problems
  • •Contraindications to apply the neuromuscular electrical stimulation (pace maker, sensory defects, etc...)

Arms & Interventions

NMES Group

Active Comparator

Intervention: NMES group will receive neuromuscular electrical stimulation using high frequency galvanic stimulation and breathing exercises.

Neuromuscular electrical stimulation will be applied bilaterally to quadriceps femoris muscle for 3days/6 weeks by a physiotherapist.

NMES group will also perform breathing exercises 120 times/day, 7 days/week, for 6 weeks.

Intervention: NMES Group (Other)

Control Group

Sham Comparator

Sham: Control group will receive breathing exercises. Control group will perform breathing exercises 120 times/day, 7 days/week, for 6 weeks.

Control group will be followed-up by telephone once a week.

Intervention: Control Group (Other)

Outcomes

Primary Outcomes

Functional exercise capacity

Time Frame: 6 weeks

Six minute walk test

Secondary Outcomes

  • Depression(6 weeks)
  • Generic quality of life(6 weeks)
  • Disease specific quality of life(6 weeks)
  • Pulmonary functions(6 weeks)
  • Inspiratory and expiratory muscle strength (MIP,MEP)(6 weeks)
  • Dyspnea(6 weeks)
  • Peripheral muscle strength(6 weeks)
  • Fatigue(6 weeks)
  • Physical activity(6 weeks)
  • Cough related quality of life(6 weeks)
  • Maximal exercise capacity(6 weeks)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Meral Boşnak Güçlü

Assoc. Prof

Gazi University

Study Sites (1)

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