euromuscular electrical stimulation (NMES) as an adjunct to pulmonary rehabilitation in patients with COPD

Not Applicable

• Conditions: Chronic lower respiratory diseases; Respiratory

• Registration Number: ISRCTN40579508
• Lead Sponsor: Royal Brompton & Harefield NHS Foundation Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-12-14
• Last Update Posted: 29 October 2019
• Study Completion: 2022-03-31

Recruitment & Eligibility

• Status: Stopped
• Sex: All
• Target Recruitment: 108

Inclusion Criteria

1. Aged =40 years
2. Confirmed diagnosis of COPD according to GOLD guidelines
3. Referred for outpatient PR
4. Quadriceps muscle weakness defined as quadriceps maximum voluntary contraction (QMVC, kg) / Body Mass Index (BMI, kg/m2) ratio =1.2
5. Able to provide written informed consent

Exclusion Criteria

1. Any condition that precludes providing informed consent e.g. cognitive impairment or inadequate English
2. Participation in an exclusively home-based pulmonary rehabilitation programme
3. Predominant neuromuscular or joint limitation to walking or cycling
4. Co-existing progressive neurological or neuromuscular condition
5. Contraindication for unsupervised use of NMES including pregnancy, implanted cardiac pacemaker, skin abrasion, metallic lower limb prosthesis
6. Formal supervised pulmonary rehabilitation in the preceding six months
7. Unstable cardiac conditions including unstable angina, unstable congestive heart failure, severe aortic stenosis, suspected aortic aneurysm
8. Active or suspected thromboembolic disease including recent pulmonary embolism
9. An acute exacerbation requiring antibiotics within the preceding four weeks

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> Cycle endurance measured using constant work rate test at 80% workload at baseline and eight-weeks.<br>

Secondary Outcome Measures

Name	Time	Method
<br> 1. Walking exercise capacity measured using incremental shuttle walk test (ISW) and endurance shuttle walk test (ESW) at baseline and eight-weeks<br> 2. Functional performance measured using short physical performance battery (SPPB), stair climb power test (SCPT) and the self-paced step test at baseline and eight weeks<br> 3. Lower limb muscle strength and mass as measured by quadriceps maximal voluntary contraction, bioelectrical impedance analysis and ultrasound at baseline and eight weeks<br> 4. Health related quality of life as measured by COPD assessment test and EQ5D5L at baseline and eight-weeks<br>