Low-load Blood Flow Restriction Training in COPD (LL-BFRT COPD)

• ClinicalTrials.gov Identifier: NCT04151771
• Recruitment Status: Recruiting
• First Posted: November 5, 2019
• Last Update Posted: February 23, 2021
• Sponsor: University of Zurich
• Information provided by (Responsible Party): University of Zurich

Tracking Information

• First Submitted Date: October 31, 2019
• First Posted Date: November 5, 2019
• Last Update Posted Date: February 23, 2021
• Actual Study Start Date: December 27, 2019
• Estimated Primary Completion Date: December 2021 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: November 4, 2019)

Knee extensor strength [ Time Frame: during 12 weeks (24 exercise sessions) ]

Between-group difference in total change in isometric muscle strength of the knee extensor muscles, measured by handheld dynamometry in newtonmeter

• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Low-load Blood Flow Restriction Training in COPD
• Official Title: Low-load Blood Flow Restriction Training in COPD

Brief Summary

Peripheral muscle weakness is a predominant problem in patients with COPD and treated using exercise training in pulmonary rehabilitation. Despite pulmonary rehabilitation being an effective intervention, muscle strength impairment is a persisting problem in COPD patients. Patients have problems to tolerate the high training loads, which are necessary to develop strength. Low-load blood flow restriction training (LL-BFRT) might therefore be an option to enhance muscular response of patients with COPD to strength training. Up to now, no studies investigating LL-BFRT in respiratory diseases are available.

The primary outcome of this randomized pilot study is knee extensor muscle strength. Secondary, the study will evaluate if LL-BFRT is well tolerated and feasible in COPD patients attending outpatient pulmonary rehabilitation.

• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Outcomes Assessor); Primary Purpose: Treatment

Condition

• COPD
• Muscle Weakness

Intervention

• Other: Low-load blood flow restriction training
  The intervention group will perform the exercises of the lower limbs using LL-BFRT with an occlusion pressure of 70% of arterial occlusion pressure with low training loads (30% of the 1 repetition maximum).
  Other Name: LL-BFRT
• Other: Usual outpatient pulmonary rehabilitation
  The control group will perform outpatient pulmonary rehabilitation as established.

Study Arms

• Experimental: LL-BFRT group
  Participants randomised into intervention group are attending pulmonary rehabilitation in which strengthening exercises of the lower limb are performed using LL-BFRT.
  Intervention: Other: Low-load blood flow restriction training
• Active Comparator: Usual pulmonary rehabilitation group
  Participants randomised into control group are attending usual pulmonary rehabilitation as established.
  Intervention: Other: Usual outpatient pulmonary rehabilitation

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: November 4, 2019): 30
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: December 2021
• Estimated Primary Completion Date: December 2021 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Diagnosed COPD according to GOLD-guidelines
• Assigned to outpatient pulmonary rehabilitation by the treating physician

Exclusion Criteria:

• Physical or intellectual impairment precluding informed consent or protocol adherence
• Non-German speaking (precluding informed consent)
• Acute or recent (within the last 6 weeks) exacerbation of COPD
• Attending a pulmonary rehabilitation program within the last 3 months
• Pregnant patients
• History of thromboembolic event in the lower extremity
• Diagnosis of polyneuropathy
• Resting systolic blood pressure <100 mmHg

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 40 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Christian F Clarenbach, MD; +41 44 255 17 12; christian.clarenbach@usz.ch

• Listed Location Countries: Switzerland

Administrative Information

• NCT Number: NCT04151771
• Other Study ID Numbers: 2019-01641; SNCTP000003509 ( Other Identifier: kofam ); 2019-01641 ( Other Identifier: KEK-ZH )
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: Undecided

• Responsible Party: University of Zurich
• Study Sponsor: University of Zurich
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: University of Zurich
• Verification Date: February 2021