Chronic Obstructive Pulmonary Disease (COPD)NCT07805330
Effects of Blood Flow Restriction Rehabilitation on Functional Mobility and Balance Among Chronic Obstructive Pulmonary Disease Patients.
A study testing Resistance Exercise without tourniquet and Blood flow restriction resistance exercise in people with Chronic Obstructive Pulmonary Disease (COPD), run by Rashid Latif Medical College at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease (COPD)
- What is being tested?
- Resistance Exercise without tourniquet and Blood flow restriction resistance exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 sitePakistan
- Study dates
- 24 Jun 2026to 25 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Upper abdominal surgery
- Lung cancer
- Open fracture
- Mental disorder
- Active malignancy
- Severe hypertension
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site, 1 recruiting
- Recruiting
Arif Memorial Teaching Hospital
Lahore, 54900
Aleena Waheed, 03214883868, alwaheed28@gmail.com
Harmeen Nadeem, Doctor of Physical Therapy
About this study
Official title: Effects of Blood Flow Restriction Rehabilitation on Functional Mobility and Balance Among Chronic Obstructive Pulmonary Disease Patients
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.
- Being tested
- Resistance Exercise without tourniquet, Blood flow restriction resistance exercise
- Keywords
- chronic obstructive pulmonary disease (COPD), Blood Flow Restriction Rehabilitation, functional mobility, balance
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resistance Exercise without tourniquetOther
The control group performed the same above-mentioned resistance training without the pressure cuff under the supervision of physiotherapist.
Blood flow restriction resistance exerciseOther
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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). Receives: Other: Blood flow restriction resistance exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Pre-intervention and 4 weeks post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2026
- Study start24 Jun 2026
- Primary completion24 Sep 2026 (estimated)
- Study completion25 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Pulmonary Disease (COPD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rashid Latif Medical College
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aleena Waheed, Rashid Latif Medical College
- Investigators
- Harmeen Nadeem, Principal investigator, Arif Memorial Teaching Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07805330
- Sponsor's protocol ID
- IRB/2024/209
- Status last verified
- Jul 2026
- First submitted
- 21 Aug 2026
- Last updated
- 4 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 38129116Lamberti 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.
PubMed 32645227Clarkson 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.
PubMed 31496953
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Blood Flow Restriction Rehabilitation on Functional Mobility and Balance Among Chronic Obstructive Pulmonary Disease Patients
- ClinicalTrials.gov ID
- NCT07805330
- Acronym / sponsor ID
- IRB/2024/209
- Keywords
- chronic obstructive pulmonary disease (COPD), Blood Flow Restriction Rehabilitation, functional mobility, balance
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Rashid Latif Medical CollegeUniversity, hospital or other
- Study start
- 24 Jun 2026 (actual)
- Primary completion
- 24 Sep 2026 (estimated)
- Study completion
- 25 Oct 2026 (estimated)
- First posted
- 4 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Resistance Exercise without tourniquet | Active comparator | Other: Resistance Exercise without tourniquetThe control group performed the same above-mentioned resistance training without the pressure cuff under the supervision of physiotherapist. |
| Blood flow restriction resistance exercise | Experimental | Other: Blood flow restriction resistance exerciseBlood 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). |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- Upper abdominal surgery
- Lung cancer
- Open fracture
- Mental disorder
- Active malignancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Resistance Exercise without tourniquetThe 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 exerciseBlood 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 |
Primary outcome
Balance
Time frame: Pre intervention and 4 weeks post intervention
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.
Oxygen Saturation
Time frame: Pre intervention and 4 weeks post intervention
Oxygen saturation reflects the percentage of haemoglobin carrying oxygen, normally ranging between 95-100% in healthy individuals.
Respiratory rate
Time frame: Pre-intervention and 4 weeks post-intervention
Respiratory rate will be measured using a pulse oximeter and recorded as the number of breaths taken per minute.
Heart Rate
Time frame: Pre-intervention and 4 weeks post-intervention
Heart rate will be measured using a pulse oximeter and recorded as the number of heartbeats per minute.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2026.
- Results publication: PubMed 38129116Kohlbrenner 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.
- Results publication: PubMed 32645227Lamberti 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.
- Results publication: PubMed 31496953Clarkson 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Harmeen Nadeem principal investigator
Arif Memorial Teaching Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Resistance Exercise without tourniquet and Blood flow restriction resistance exercise in people with Chronic Obstructive Pulmonary Disease (COPD), run by Rashid Latif Medical College at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Aleena Waheed, Masters in Physical Therapy (03214883868, alwaheed28@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Balance (time frame: Pre intervention and 4 weeks post intervention). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07805330, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2026.