Effects of Neuromuscular Electrical Stimulation as an Adjunct to Exercise Training in Stable Chronic Obstructive Pulmonary Disease (COPD)

NCT01658046 | Completed DMC

• 2 other identifiers: NMES-COPDHacettepe University
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief Summary

Skeletal muscle dysfunction impairs exercise capacity, quality of life and prognosis in chronic obstructive pulmonary disease (COPD). The purpose of this prospective randomized controlled study was to evaluate effects of Neuromuscular electrical stimulation (NMES) plus quadriceps muscle training (NMES group) and sham NMES plus quadriceps muscle training (control group) on muscle function, exercise capacity, health related quality of life, activities of daily living, and self-efficacy in patients with COPD who are eligible and able to participate in endurance training.

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Keywords

COPD; exercise; neuromuscular electrical stimulation

Outcome Measures

Primary Outcomes (1)

• Incremental shuttle walk test

  The incremental shuttle walk test was performed in an enclosed corridor. Patients were required to walk back and forth, turning around two cones placed 9 meters apart making the shuttle distance 10 meters long. Patients followed the rhythm dictated by the audio signal.

  10 weeks

Secondary Outcomes (1)

• Endurance shuttle walk test

  10 weeks

Study Arms (2)

NMES group

EXPERIMENTAL

10 weeks neuromuscular electrical stimulation plus endurance training and quadriceps strength training.

Other: Neuromuscular electrical stimulation; Other: Endurance training; Other: Quadriceps strength training

Control group

SHAM COMPARATOR

10 weeks sham neuromuscular electrical stimulation plus endurance training and quadriceps strength training.

Other: Endurance training; Other: Quadriceps strength training

Interventions

Neuromuscular electrical stimulation OTHER

Bilateral quadriceps NMES using a four-channel portable electrical stimulator. Biphasic symmetric constant current impulses with a pulse width 300 µs, a frequency of 50 Hz, and duty cycle of 10 s on and 20 s off was applied for 20 min per day, 2 days per week for 10 weeks.

NMES group

Endurance training OTHER

Endurance training consists of 30 minutes of aerobic exercise (15 minutes on treadmill and 15 minutes on stationary bicycle) at 80% of maximal heart rate

Control group; NMES group

Quadriceps strength training OTHER

Quadriceps resistance training was applied using free weights for 2 days per week for 10 weeks according to 1 repetition maximum, starting at 45% for two sets.

Control group; NMES group

Eligibility Criteria

• Age: 35 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• diagnosis of chronic obstructive pulmonary disease
• being 35-75 years of age
• being eligible to participate in endurance trainin
• no acute exacerbation in last month, no change in drugs and no usage of antibiotics in last three weeks

You may not qualify if:

• medical conditions which could place patient at risk during neuromuscular electrical stimulation and exercise training (orthophedic and neuromuscular disorders, metal implants in the lower limbs, advanced heart failure, aortic stenosis, deep venous thrombosis a cardiac pacemaker, \>50 mmHg pulmonary artery pressure and/or an acute exacerbation of symtomps in the preceeding four weeks)
• being unable to understand the questionnaires and unable to cooparate.

Sponsors & Collaborators

• Hacettepe University: lead
• Atatürk Chest Diseases and Chest Surgery Training and Research Hospital: collaborator

Study Sites (1)

Ataturk Chest Diseases and Thoracic Surgery Training and Research Hospital

Ankara, 06280, Turkey (Türkiye)

Location

Related Publications (1)

• Tasdemir F, Inal-Ince D, Ergun P, Kaymaz D, Demir N, Demirci E, Egesel N. Neuromuscular electrical stimulation as an adjunct to endurance and resistance training during pulmonary rehabilitation in stable chronic obstructive pulmonary disease. Expert Rev Respir Med. 2015 Aug;9(4):493-502. doi: 10.1586/17476348.2015.1068691. Epub 2015 Jul 15.

  PMID: 26175226 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Motor Activity

Interventions

Endurance Training

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Deniz Inal-Ince, PhD, PT

  Hacettepe University

  PRINCIPAL INVESTIGATOR

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: PhD, PT, Associated Professor

Study Record Dates

• First Submitted: July 31, 2012
• First Posted: August 6, 2012
• Study Start: July 1, 2009
• Primary Completion: August 1, 2011
• Study Completion: August 1, 2011
• Last Updated: August 6, 2012

Record last verified: 2012-08

Locations

TU (1)