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Knee OsteoarthristisNCT07722975

Effects of Intermittent Versus Continuous Blood Flow Restriction Training on Pain, Functional Ability, Muscle Strength and Exercise Perception Among Female Patients With Grade II Knee Osteoarthritis

A study testing Intermittent blood flow training (iBFR) and Continuous blood flow training (cBFR) in people with Knee Osteoarthristis, run by Lahore University of Biological and Applied Sciences at 1 site in Pakistan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study holds significant clinical, academic, and practical importance in the field of musculoskeletal rehabilitation. Clinically, it addresses a critical need to identify an effective and tolerable strengthening strategy for females with early-stage knee osteoarthritis. Read more about this study

Who is it for?
Ages 40 to 49 years, women only
Conditions the study is for
Knee Osteoarthristis
What is being tested?
Intermittent blood flow training (iBFR) and Continuous blood flow training (cBFR)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
84 participants
Where
1 sitePakistan
Study dates
1 May 2026to 20 Jul 2026
Phase
Interventional
Are there results?
None posted in the registry

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 40 to 49 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • Female patients aged 40-49 years.
  • Diagnosed with Grade II knee osteoarthritis (radiographically confirmed).
  • Moderate to severe pain (NPRS 4-7).
  • Ability to participate in exercise programs.

Who cannot join

  • Severe cardiovascular disease.
  • Uncontrolled hypertension.
  • Recent knee surgery or intra-articular injection.
  • Active cancer or metastatic disease

Trial locations and contacts

1 site in 1 country.

Pakistan1 site
  • Social Security Hospital, Lahore

    Lahore, Punjab Province, 05450

Other trials in Pakistan

About this study

This study holds significant clinical, academic, and practical importance in the field of musculoskeletal rehabilitation. Clinically, it addresses a critical need to identify an effective and tolerable strengthening strategy for females with early-stage knee osteoarthritis. By directly comparing intermittent and continuous BFR protocols, the findings will provide physiotherapists with evidence-based guidance for optimizing exercise prescription while minimizing discomfort and improving adherence.Academically, this research contributes to the limited body of literature comparing different BFR application strategies in knee osteoarthritis. The inclusion of exercise perception outcomes adds valuable insight into patient-centered rehabilitation, which is often underrepresented in clinical trials.From a practical and societal perspective, identifying a more tolerable BFR approach may enhance long-term exercise participation, delay disease progression, and reduce healthcare burden associated with knee osteoarthritis. The findings may also support the integration of low-load BFR training into rehabilitation programs in resource-limited clinical settings.

Read the detailed description

Knee osteoarthritis (KOA) is a chronic, progressive musculoskeletal disorder characterized by joint degeneration, pain, muscle weakness, and functional limitations, with a higher prevalence among middle-aged women. Quadriceps muscle weakness is a key clinical feature associated with reduced functional capacity and progression of the disease. Although high-load resistance training is considered effective for improving muscle strength, its application is often limited in symptomatic individuals due to increased joint loading and pain, thereby affecting adherence to rehabilitation programs.In recent years, low-load resistance training combined with Blood Flow Restriction (BFR) has gained attention as a viable alternative for enhancing muscle strength while minimizing mechanical stress on the joint. BFR training can be applied using continuous or intermittent protocols. Continuous BFR maintains cuff pressure throughout both exercise and rest periods, whereas intermittent BFR involves periodic deflation during rest intervals. These variations may influence physiological responses, fatigue levels, perceived exertion, and overall exercise tolerance, which are critical factors in clinical rehabilitation.This randomized controlled trial is designed to compare the effects of intermittent and continuous BFR training on pain, functional ability, muscle strength, and exercise perception in females with Grade II knee osteoarthritis. A total of 84 participants will be randomly allocated into two intervention groups and will undergo structured low-load resistance training in conjunction with standard physiotherapy care over a period of 8-12 weeks.Outcome measures will be assessed at baseline, 4 weeks, 8 weeks, and 12 weeks, including pain intensity (Numeric Pain Rating Scale), functional status (WOMAC Index), quadriceps muscle strength, and perceived exertion (Modified Borg Scale). The findings of this study are expected to provide evidence-based insights into the comparative effectiveness and tolerability of BFR application methods, thereby supporting optimized rehabilitation strategies and improving patient-centered outcomes in knee osteoarthritis management.

Being tested
Intermittent blood flow training (iBFR), Continuous blood flow training (cBFR)
Keywords
Blood Flow Restriction (BFR), Intermittent BFR, Continuous BFR, Exercise Perception, Functional Ability

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Intermittent blood flow training (iBFR)Other

    Hamstrings stretching, 3 repetitions of 30 s, Bridge with isometric contraction of the transversus abdominis-CORE training, 3 repetitions of 30 s, Hip abduction with weights , 3 sets of 10 repetitions, Calm exercises with an elastic band, 3 sets of 10 repetitions, Calf raises with weights , 3 sets of 10 repetitions, Sensori-motor training at mini-trampoline, 3 repetitions of 30 s, Leg press, 0-60°, 4 sets of 10 repetitions, Seated knee extension , 90-0° of knee flexion, 4 sets of 10 repetitions. In the iBFR group, the cuff is deflated during each set's rest period and is quickly reinflated to the target pressure 20-30 s into the rest, ensuring the entire rest period does not exceed 45 s . Intensity: 20- 30% of 1RM with BFR cuffs, Frequency: 3 sessions per week for 12 weeks. Each session comprises a 10-min warm up with static cycling, a 30-min exercise program, and a 15-min cool down. BFR cuff from Hhccteo company will be used. pressure:130-150 mmHg, cuff width 5-7cm

  • Continuous blood flow training (cBFR)Other

    Hamstrings stretching, 3 repetitions of 30 s, Bridge with isometric contraction of the transversus abdominis-CORE training, 3 repetitions of 30 s, Hip abduction with weights (side lying), 3 sets of 10 repetitions, Calm exercises (side lying) with an elastic band, 3 sets of 10 repetitions, Calf raises with weights (standing), 3 sets of 10 repetitions, Sensori motor training (standing) at mini-trampoline, 3 repetitions of 30 s, Leg press (machine), 0-60°, 4 sets of 10 repetitions, Seated knee extension, 90-0° of knee flexion, 4 sets of 10 repetitions. In the cBFR group, the Intensity of excersise will be 20-30% of 1RM with BFR cuffs ,Frequency: 3 sessions per week for 12 weeks. Each session comprises a 10-min warmup with static cycling, a 30-min exercise program, and a 15-min cool down. BFR cuff from Hhccteo company will be used. The parameters will be pressure: 130-150 mmHg, cuff width 5-7 cm. Progressive overload will be applied by gradually increasing repetitions or load as tolerated

Study groups in NCT07722975
Study groupRoleWhat they receive
Intermittent blood flowExperimentalParticipants will perform low-load resistance exercises at 20-30% of one-repetition maximum (1RM) combined with intermittent BFR application. Cuff pressure will be applied during exercise sets and released during rest intervals. Each session will include a 10-minute warm-up , followed by a 30-minute structured exercise program and a 15-minute cool-down. Sessions will be conducted 2-3 times per week for a duration of 8-12 weeks, with progressive overload applied as tolerated.
Receives: Other: Intermittent blood flow training (iBFR)
Continuous blood flow trainingExperimentalParticipants will perform the same low-load resistance exercise protocol (20-30% 1RM) with continuous BFR application. Cuff pressure will be maintained throughout both exercise and rest periods. Exercise selection, session structure (warm-up, training, cool-down), frequency (2-3 sessions/week), and duration (8-12 weeks) will be identical to Group A to ensure comparability between groups
Receives: Other: Continuous blood flow training (cBFR)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Manual Muscle Testing (MMT)

    Quadriceps strength will be assessed using standardized isometric testing procedure. It grades muscle strength on a 0-5 scale based on the ability to move a joint against gravity and external resistance. A grade of 0 indicates no visible or palpable muscle contraction, while 1 (Trace) represents a slight contraction without actual movement. Grade 2 (Poor) describes the ability to move the joint through its full range only when gravity is eliminated, whereas Grade 3 (Fair) allows movement through the full range against gravity but without resistance. Grade 4 (Good) indicates movement against moderate resistance, and Grade 5 (Normal) reflects full range of motion against maximal resistance, representing normal muscle strength

    Measured: baseline, 6 weeks (post intervention), 12 weeks (follow up)

  2. Numeric Pain Rating Scale (NPRS)

    The NPRS is a10-point scale (0-10) used to quantify pain intensity. Pain severity will be interpreted as no pain (0), mild pain (1-3), moderate pain (4-6), and severe pain (7-10).

    Measured: baseline, 6 weeks (post intervention), 12 weeks( followup)

  3. Modified Borg Scale

    It is used to assess ratings of exercise-related perceived exertion. The scale ranges from (0 to 10), where 0 means no breathlessness at all and 10 means maximium breathlessness. According to this, 0-2 for Minimal exertion, 3-4 for Moderate (often target for rehab), 5-6 for Hard and 7-10 is for Very hard to maximal

    Measured: baseline, 6 weeks( post intervention), 12 weeks (follow up)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Jul 2026
  2. Study start1 May 2026
  3. Primary completion10 Jul 2026
  4. Study completion20 Jul 2026

Resources

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
This study will use a parallel-group randomized controlled design, with participants randomly allocated into two intervention groups. Group A (Intermittent Blood Flow Restriction - iBFR): participants will perform low-load resistance exercises (20-30% 1RM) with BFR cuffs (130-150 mmHg) applied during exercise and released during rest intervals. Group B (Continuous Blood Flow Restriction - cBFR): participants will perform the same exercise protocol with cuff pressure maintained throughout both exercise and rest periods. Both groups will receive identical exercise programs including leg press, knee extension, hip abduction, calf raises, and core exercises, along with standard physiotherapy care. Sessions will be conducted 2-3 times per week for 8-12 weeks. Participants will be randomly assigned into two parallel groups without crossover to ensure unbiased comparison of outcomes.
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
84 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07722975
Sponsor's protocol ID
UBAS/ERB/26/04/012
Status last verified
Jul 2026
First submitted
20 Jul 2026
Last updated
23 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Freitas EDS, Miller RM, Heishman AD, Aniceto RR, Silva JGC, Bemben MG. Perceptual responses to continuous versus intermittent blood flow restriction exercise: A randomized controlled trial. Physiol Behav. 2019 Dec 1;212:112717. doi: 10.1016/j.physbeh.2019.112717. Epub 2019 Oct 17.

    PubMed 31629764
  • Harper SA, Roberts LM, Layne AS, Jaeger BC, Gardner AK, Sibille KT, Wu SS, Vincent KR, Fillingim RB, Manini TM, Buford TW. Blood-Flow Restriction Resistance Exercise for Older Adults with Knee Osteoarthritis: A Pilot Randomized Clinical Trial. J Clin Med. 2019 Feb 21;8(2):265. doi: 10.3390/jcm8020265.

    PubMed 30795545
  • Sorensen B, Aagaard P, Hjortshoj MH, Hansen SK, Suetta C, Couppe C, Magnusson SP, Johannsen FE. Physiological and clinical effects of low-intensity blood-flow restricted resistance exercise compared to standard rehabilitation in adults with knee osteoarthritis-Protocol for a randomized controlled trial. PLoS One. 2023 Dec 14;18(12):e0295666. doi: 10.1371/journal.pone.0295666. eCollection 2023.

    PubMed 38096198
  • Centner C, Wiegel P, Gollhofer A, Konig D. Effects of Blood Flow Restriction Training on Muscular Strength and Hypertrophy in Older Individuals: A Systematic Review and Meta-Analysis. Sports Med. 2019 Jan;49(1):95-108. doi: 10.1007/s40279-018-0994-1.

    PubMed 30306467
  • Hughes L, Paton B, Rosenblatt B, Gissane C, Patterson SD. Blood flow restriction training in clinical musculoskeletal rehabilitation: a systematic review and meta-analysis. Br J Sports Med. 2017 Jul;51(13):1003-1011. doi: 10.1136/bjsports-2016-097071. Epub 2017 Mar 4.

    PubMed 28259850

Questions about this trial

What is this clinical trial studying?

A study testing Intermittent blood flow training (iBFR) and Continuous blood flow training (cBFR) in people with Knee Osteoarthristis, run by Lahore University of Biological and Applied Sciences 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 4 inclusion and 4 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: finished, as of the sponsor's last update on 23 Jul 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Manual Muscle Testing (MMT) (time frame: baseline, 6 weeks (post intervention), 12 weeks (follow up)). The study lists 3 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 NCT07722975, which also lists 5 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 23 Jul 2026; AzTrials last refreshed its copy on 26 Oct 2026.

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