Osteoarthritis, KneeBFRNCT04865692
Effects of Low Intensity Blood Flow Restriction on Clinical Outcomes in Women With Knee Osteoarthritis
A study testing BFRT and Routine Physical Therapy in people with Osteoarthritis, Knee, run by University of Lahore at 1 site in Pakistan.
Trial summary
Objective is to compare the effects of routine physical therapy with and without low intensity blood flow restriction on pain and quadriceps muscle strength in women with knee osteoarthritis. Read more about this study
- Who is it for?
- Ages 45 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- BFRT and Routine Physical Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 sitePakistan
- Study dates
- 15 Feb 2018to 15 Sep 2020
- 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 45 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Diagnosed patients of grade II knee osteoarthritis
- Patient's age 45-65
Who cannot join
- Bilateral knee replacement
- Lower limb surgery in the last six months
- Diagnosis of inflammatory joint or muscle disease
- Chest pain during exercise or at rest; or need for supplemental oxygen
- Pregnancy
- Any systemic disease
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
University of Lahore Teaching Hospital
Lahore, Punjab Province, 54000
About this study
Official title: Effects of Blood Flow Restriction on Clinical Outcomes in Women With Knee Osteoarthritis
Objective is to compare the effects of routine physical therapy with and without low intensity blood flow restriction on pain and quadriceps muscle strength in women with knee osteoarthritis.
A single blinded randomized controlled trial conducted at Department of Physiotherapy, University of Lahore Teaching Hospital, Defense Road, Lahore.
Read more
Total 60 participants were randomly assigned in to two groups, with 30 in each group The intervention group received routine physiotherapy program combined with Low Intensity Blood Flow Restriction Technique (LI-BFR. While control group were treated with only routine physiotherapy.
Dynamometer was used to assess the knee extensor strength while Knee injury and osteoarthritis outcome score was used to record any exacerbation in pain and effects of BFR on activities of daily living. Training load determined 20% of 1RM. Data analysis had done on SPSS version 23.
Read the detailed description
nonparametric test Friedman test was for comparison within the groups and Mann Whitney U test was used for comparison between groups.
Randomization had done through the sealed envelope method. After allocation subjects had received their treatment protocals.
- Conditions
- Osteoarthritis, Knee
- Being tested
- BFRT, Routine Physical Therapy
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BFRTOther
Patients of Interventional group were treated with routine physiotherapy program combined with LI-BFR consist of 10 minutes' session 3 per week for 12 weeks. In order to determine the training load 20% of 1RM, participants had performed knee extension in full range with a challenging weight. After each test, participants rated their perceived exertion level on (RPE) scale to determine the difficulty of the resistance. The derived 1RM was used to determine the 20% 1RM load used for low-load training. Blood flow restriction proximal to the working muscles achieved through using pressure cuffs. The cuff was applied to the proximal thigh. During week 1 the inflation pressure was 100mmHg. Final exercise pressure based the week of the training. Quadriceps size was measured by tape measures thigh
Routine Physical TherapyOther
knee isometrics, resisted knee extension with chalanging weight 2 sets of 10 Reps with 5 sec hold
| Study group | Role | What they receive |
|---|---|---|
| Interventional group | Experimental | The interventional group received resisted knee extension 20% of 1RM with blood flow restriction along with routine physical therapy. Receives: Other: BFRT; Other: Routine Physical Therapy |
| Control Group | Other | The Control group received routine physical therapy alone including knee isometrics and resisted knee extension Receives: Other: Routine Physical Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quadriceps muscle strength
dynamometer was used to assess strength
Measured: 12 Weeks
thigh muscle size
measuring tape was used to measure
Measured: 12 weeks
Pain
pain was measured through NPRS
Measured: 12 weeks
Secondary outcomes (1)
Activities of daily living
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2021
- Study start15 Feb 2018
- Primary completion15 Feb 2020
- Study completion15 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
- More trials run by University of LahoreThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Lahore
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- zoya Mujahid, DPT, Study chair, University of Lahore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04865692
- Sponsor's protocol ID
- 719-II
- Acronym
- BFR
- Status last verified
- Apr 2021
- First submitted
- 26 Apr 2021
- Last updated
- 29 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Blood Flow Restriction on Clinical Outcomes in Women With Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT04865692
- Acronym / sponsor ID
- BFR / 719-II
- Conditions
- Osteoarthritis, Knee
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of LahoreUniversity, hospital or other
- Study start
- 15 Feb 2018 (actual)
- Primary completion
- 15 Feb 2020 (actual)
- Study completion
- 15 Sep 2020 (actual)
- First posted
- 29 Apr 2021 (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.
Objective is to compare the effects of routine physical therapy with and without low intensity blood flow restriction on pain and quadriceps muscle strength in women with knee osteoarthritis.
A single blinded randomized controlled trial conducted at Department of Physiotherapy, University of Lahore Teaching Hospital, Defense Road, Lahore.
Total 60 participants were randomly assigned in to two groups, with 30 in each group The intervention group received routine physiotherapy program combined with Low Intensity Blood Flow Restriction Technique (LI-BFR. While control group were treated with only routine physiotherapy.
Dynamometer was used to assess the knee extensor strength while Knee injury and osteoarthritis outcome score was used to record any exacerbation in pain and effects of BFR on activities of daily living. Training load determined 20% of 1RM. Data analysis had done on SPSS version 23.
Detailed description
nonparametric test Friedman test was for comparison within the groups and Mann Whitney U test was used for comparison between groups.
Randomization had done through the sealed envelope method. After allocation subjects had received their treatment protocals.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interventional group | Experimental | Other: BFRT, Other: Routine Physical TherapyThe interventional group received resisted knee extension 20% of 1RM with blood flow restriction along with routine physical therapy. |
| Control Group | Other | Other: Routine Physical TherapyThe Control group received routine physical therapy alone including knee isometrics and resisted knee extension |
Who may qualify
- Ages
- 45 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Diagnosed patients of grade II knee osteoarthritis
- Patient's age 45-65
Key exclusion criteria (6 listed)
- Bilateral knee replacement
- Lower limb surgery in the last six months
- Diagnosis of inflammatory joint or muscle disease
- Chest pain during exercise or at rest; or need for supplemental oxygen
- Pregnancy
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 |
|---|---|---|
| BFRTPatients of Interventional group were treated with routine physiotherapy program combined with LI-BFR consist of 10 minutes' session 3 per week for 12 weeks. In order to determine the training load 20% of 1RM, participants had performed knee extension in full range with a challenging weight. After each test, participants rated their perceived exertion level on (RPE) scale to determine the difficulty of the resistance. The derived 1RM was used to determine the 20% 1RM load used for low-load training. Blood flow restriction proximal to the working muscles achieved through using pressure cuffs. The cuff was applied to the proximal thigh. During week 1 the inflation pressure was 100mmHg. Final exercise pressure based the week of the training. Quadriceps size was measured by tape measures thigh | Other | Interventional group |
| Routine Physical Therapyknee isometrics, resisted knee extension with chalanging weight 2 sets of 10 Reps with 5 sec hold | Other | Control Group, Interventional group |
Primary outcome
Quadriceps muscle strength
Time frame: 12 Weeks
dynamometer was used to assess strength
thigh muscle size
Time frame: 12 weeks
measuring tape was used to measure
Pain
Time frame: 12 weeks
pain was measured through NPRS
1 secondary outcome
Activities of daily living
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2021.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
zoya Mujahid, DPT study chair
University of Lahore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BFRT and Routine Physical Therapy in people with Osteoarthritis, Knee, run by University of Lahore 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 2 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: finished, as of the sponsor's last update on 29 Apr 2021. 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?
Quadriceps muscle strength (time frame: 12 Weeks). 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?
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 29 Apr 2021.