NCT07649850

Brief Summary

This randomized controlled trial investigated the effects of combining aerobic exercise with blood flow restriction (BFR) training in patients with emphysematous chronic obstructive pulmonary disease (COPD). The study aimed to determine whether adding BFR to aerobic exercise could enhance muscle strength and functional capacity compared with conventional training alone. The findings demonstrated that aerobic exercise combined with BFR significantly improved lower-limb muscle strength, exercise tolerance, and functional performance in patients with emphysematous COPD. These results suggest that BFR-assisted aerobic training may serve as an effective and safe rehabilitation strategy to improve physical function and quality of life in this population.

Trial Health

65
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
1mo left

Started Jun 2026

Shorter than P25 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress70%
Jun 2026Aug 2026

First Submitted

Initial submission to the registry

May 14, 2026

Completed
27 days until next milestone

Study Start

First participant enrolled

June 10, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 16, 2026

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 15, 2026

Expected
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2026

Last Updated

June 16, 2026

Status Verified

June 1, 2026

Enrollment Period

2 months

First QC Date

May 14, 2026

Last Update Submit

June 11, 2026

Conditions

Keywords

emphysematous COPDlood flow restriction (BFR)aerobic exercise

Outcome Measures

Primary Outcomes (1)

  • muscle strength

    quadriceps strength by isokinetic: Quadriceps strength will be measured using an isokinetic dynamometer at an angular velocity of 60°/s. Participants will perform three to five maximal concentric knee extension efforts after familiarization. Peak torque (Nm) will be recorded, and the highest value will be used for statistical analysis

    8 weeks

Secondary Outcomes (1)

  • function capacity

    8 weeks

Study Arms (2)

experimental group

EXPERIMENTAL

aerobic exercise with blood flow restriction (BFR) training Procedure: Aerobic Exercise Training Device: Blood Flow Restriction Cuff

Other: Aerobic Exercise Combined with Blood Flow Restriction

control group

EXPERIMENTAL

aerobic exercise

Other: Aerobic exercise

Interventions

Aerobic exercise combined with blood flow restriction (BFR) is a rehabilitation technique in which patients perform low- to moderate-intensity aerobic exercise, such as treadmill or cycling training, while a specialized cuff is applied around the proximal part of the limb to partially restrict blood flow. This method aims to enhance muscle strength and functional performance using lower exercise intensity, making it suitable for patients with limited exercise tolerance, such as individuals with COPD.

experimental group

The control group performed conventional aerobic exercise training at low to moderate intensity without the application of blood flow restriction. The program included activities such as treadmill walking or cycling to improve cardiovascular endurance, functional capacity, and overall physical fitness in patients with COPD.

control group

Eligibility Criteria

Age50 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients diagnosed with emphysematous chronic obstructive pulmonary disease (COPD).
  • Clinically stable COPD patients with no acute exacerbation within the previous 4-6 weeks.
  • Mild to moderate disease severity according to GOLD criteria.
  • Ability to participate safely in aerobic exercise training.
  • Medically stable and cleared by a physician for pulmonary rehabilitation.
  • Ability to understand and follow study instructions.

You may not qualify if:

  • Acute COPD exacerbation or respiratory infection during the study period.
  • Severe cardiovascular diseases (e.g., unstable angina, uncontrolled hypertension, recent myocardial infarction).
  • Peripheral vascular disease or contraindications to blood flow restriction (BFR) training.
  • Severe musculoskeletal, neurological, or orthopedic disorders limiting exercise performance.
  • Cognitive impairment affecting cooperation or informed consent.
  • Participation in another structured rehabilitation program during the study period.
  • Severe hypoxemia requiring continuous oxygen therapy during exercise.
  • History of deep vein thrombosis or clotting disorders.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

EmphysemaPulmonary Disease, Chronic Obstructive

Interventions

Exercise

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsLung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease Attributes

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
associate professor hanan hosny M Battesha

Study Record Dates

First Submitted

May 14, 2026

First Posted

June 16, 2026

Study Start

June 10, 2026

Primary Completion (Estimated)

August 15, 2026

Study Completion (Estimated)

August 30, 2026

Last Updated

June 16, 2026

Record last verified: 2026-06