Low-load Blood Flow Restriction Training in COPD

NCT04151771 | Completed

• 2 other identifiers: 2019-01641SNCTP000003509
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

COPD; Muscle Weakness

Keywords

blood flow restriction training; pulmonary rehabilitation; COPD; muscle weakness

Outcome Measures

Primary Outcomes (1)

• Knee extensor strength

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

  during 12 weeks (24 exercise sessions)

Study Arms (2)

LL-BFRT group

EXPERIMENTAL

Participants randomised into intervention group are attending pulmonary rehabilitation in which strengthening exercises of the lower limb are performed using LL-BFRT.

Other: Low-load blood flow restriction training

Usual pulmonary rehabilitation group

ACTIVE COMPARATOR

Participants randomised into control group are attending usual pulmonary rehabilitation as established.

Other: Usual outpatient pulmonary rehabilitation

Interventions

Low-load blood flow restriction training OTHER

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).

Also known as: LL-BFRT

LL-BFRT group

Usual outpatient pulmonary rehabilitation OTHER

The control group will perform outpatient pulmonary rehabilitation as established.

Usual pulmonary rehabilitation group

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Zurich: lead

Study Sites (1)

University Hospital Zurich

Zurich, 8091, Switzerland

Location

Related Publications (1)

• Kohlbrenner D, Kuhn M, Manettas A, Aregger C, Peterer M, Greco N, Sievi NA, Clarenbach C. Low-load blood flow restriction strength training in patients with COPD: a randomised single-blind pilot study. Thorax. 2024 Mar 15;79(4):340-348. doi: 10.1136/thorax-2023-220546.

  PMID: 38129116 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Muscle Weakness

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 31, 2019
• First Posted: November 5, 2019
• Study Start: December 27, 2019
• Primary Completion: January 28, 2023
• Study Completion: January 28, 2023
• Last Updated: April 12, 2023

Record last verified: 2023-04

Locations

CH (1)