Effects of Blood Flow Restriction Rehabilitation on Functional Mobility and Balance Among Chronic Obstructive Pulmonary Disease Patients.

NCT07805330 | Recruiting

• 1 other identifier: IRB/2024/209
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Background: Chronic obstructive pulmonary disease (COPD) is a common lung disease causing restricted airflow and breathing problems. It is sometimes called emphysema or chronic bronchitis. The damage results in swelling and irritation, also called inflammation, inside the airways that limit airflow into and out of the lungs. BFR Rehabilitation is effective in improving functional mobility and balance among COPD patients. Objective: To find out the effects of Blood Flow Restriction (BFR) Rehabilitation on functional mobility and balance among COPD (Chronic Obstructive Pulmonary Disease) patients. Methods: A Randomized Controlled Trial Study was conducted at Gulab Devi Hospital, Hameed Latif Hospital and Arif Memorial Teaching Hospital Lahore. Fifty patients of age 45-60 years with COPD were randomized into two groups. Allocation of patients in two equal groups by lottery method will be through random assignment. Group A was treated with controlled physical therapy while Group B was treated with BFR rehabilitation. Controlled treatment includes low intensity resistance exercises while BFR Rehabilitation includes use of a tourniquet with low intensity resistance exercises. All this information will be collected through a pulse oximeter. Berg Balance Scale will be used for balance and timed up and go test for functional mobility.

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Keywords

chronic obstructive pulmonary disease (COPD); Blood Flow Restriction Rehabilitation; functional mobility; balance

Outcome Measures

Primary Outcomes (4)

• Balance

  Balance was assessed using the Berg Balance Scale (BBS), a widely used clinical tool that evaluated functional balance through 14 tasks of varying difficulty. Each task was scored from 0-4, with a maximum score of 56. Higher scores indicated better balance, while lower scores reflected greater fall risk.

  Pre intervention and 4 weeks post intervention

• Oxygen Saturation

  Oxygen saturation reflects the percentage of haemoglobin carrying oxygen, normally ranging between 95-100% in healthy individuals.

  Pre intervention and 4 weeks post intervention

• Respiratory rate

  Respiratory rate will be measured using a pulse oximeter and recorded as the number of breaths taken per minute.

  Pre-intervention and 4 weeks post-intervention

• Heart Rate

  Heart rate will be measured using a pulse oximeter and recorded as the number of heartbeats per minute.

  Pre-intervention and 4 weeks post-intervention

Study Arms (2)

Resistance Exercise without tourniquet

ACTIVE COMPARATOR

The control group performed the same above-mentioned resistance training without the pressure cuff under the supervision of physiotherapist.

Other: Resistance Exercise without tourniquet

Blood flow restriction resistance exercise

EXPERIMENTAL

Blood flow restriction resistance exercise (BFR-RE), or Kaatsu training, was developed by Dr. Yoshiaki Sato over 40 years ago. It uses a low load (15-30% 1-RM) to induce gains in muscle strength and mass. External pressure (\~80% limb occlusion pressure, LOP) is applied via a tourniquet cuff to the proximal limb, restricting venous return while allowing partial arterial inflow, creating blood pooling in distal muscles. Training was supervised by BFR-certified physiotherapists using medium-sized cuffs, placed at the proximal thigh for a maximum of 10 minutes. Pressure was auto-adjusted to personalized LOP, inflated before the first set, maintained during rests, and deflated post-session. Each session trained a single limb, alternated on different days, 2-3 times/week. Exercises included isotonic knee extensions from 150° to 180°: 1 set of 30 reps, then 3 sets of 15 reps, with 30-second rests, at 1-2 sec/repetition, using sandbag resistance (15-30% 1-RM).

Other: Blood flow restriction resistance exercise

Interventions

Resistance Exercise without tourniquet OTHER

The control group performed the same above-mentioned resistance training without the pressure cuff under the supervision of physiotherapist.

Resistance Exercise without tourniquet

Blood flow restriction resistance exercise OTHER

Blood flow restriction resistance exercise (BFR-RE), or Kaatsu training, was developed by Dr. Yoshiaki Sato over 40 years ago. It uses a low load (15-30% 1-RM) to induce gains in muscle strength and mass. External pressure (\~80% limb occlusion pressure, LOP) is applied via a tourniquet cuff to the proximal limb, restricting venous return while allowing partial arterial inflow, creating blood pooling in distal muscles. Training was supervised by BFR-certified physiotherapists using medium-sized cuffs, placed at the proximal thigh for a maximum of 10 minutes. Pressure was auto-adjusted to personalized LOP, inflated before the first set, maintained during rests, and deflated post-session. Each session trained a single limb, alternated on different days, 2-3 times/week. Exercises included isotonic knee extensions from 150° to 180°: 1 set of 30 reps, then 3 sets of 15 reps, with 30-second rests, at 1-2 sec/repetition, using sandbag resistance (15-30% 1-RM).

Blood flow restriction resistance exercise

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects who are clinically stable before study
• Forced expiratory volume in 1s (FEV1)/forced vital capacity (FVC)\<70% and FEV1 ≥30% but \<80% respectively
• Subjects who will be willing to take part in this study

You may not qualify if:

• Upper abdominal surgery
• Lung cancer
• Open fracture
• Mental disorder
• Active malignancy
• Severe hypertension

Sponsors & Collaborators

• Rashid Latif Medical College: lead

Study Sites (1)

Arif Memorial Teaching Hospital

Lahore, 54900, Pakistan

RECRUITING

Related Publications (3)

• 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 RESULT

• Lamberti N, Straudi S, Donadi M, Tanaka H, Basaglia N, Manfredini F. Effectiveness of blood flow-restricted slow walking on mobility in severe multiple sclerosis: A pilot randomized trial. Scand J Med Sci Sports. 2020 Oct;30(10):1999-2009. doi: 10.1111/sms.13764. Epub 2020 Jul 25.

  PMID: 32645227 RESULT

• Clarkson MJ, May AK, Warmington SA. Chronic Blood Flow Restriction Exercise Improves Objective Physical Function: A Systematic Review. Front Physiol. 2019 Aug 21;10:1058. doi: 10.3389/fphys.2019.01058. eCollection 2019.

  PMID: 31496953 RESULT

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Tourniquets

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Equipment and Supplies

Study Officials

• Harmeen Nadeem

  Arif Memorial Teaching Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Aleena Waheed, Masters in Physical Therapy

CONTACT

03214883868; alwaheed28@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Lecturer

Study Record Dates

• First Submitted: August 21, 2026
• First Posted: September 4, 2026
• Study Start: June 24, 2026
• Primary Completion: September 24, 2026
• Study Completion (Estimated): October 25, 2026
• Last Updated: September 4, 2026

Record last verified: 2026-07

Locations

PA (1)