Osteoarthritis, KneeNCT05058794
Comparison Among the Effects of Blood Flow Restriction Training and Conventional Exercise in Knee Osteoarthritis.
A study testing Blood flow Restriction/Resistance Training and Conventional Therapy Group in people with Osteoarthritis, Knee and Hypertrophy, run by Riphah International University at 2 sites in Pakistan.
Trial summary
The main objective of the study is to compare the effects of Blood flow Restriction training vs. traditional exercises on knee pain , knee functional disability and on quadriceps strength in patient with knee osteoarthritis. Read more about this study
- Who is it for?
- Ages 40 to 60 years
- Conditions the study is for
- Osteoarthritis, Knee, Hypertrophy
- What is being tested?
- Blood flow Restriction/Resistance Training and Conventional Therapy Group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 2 sitesPakistan
- Study dates
- 10 Oct 2021to 11 Feb 2022
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Pain : Subjects having unilateral or bilateral pain
- Pain type : subjects having chronic pain
- Includes diagnosed cases of knee osteoarthritis
- grades 2-3 according to the Kellgren and Lawrence method of grading
- Includes knee osteoarthritis patients with lateral tracking of patella which will assessed through Q angle test
Who cannot join
- Any other orthopaedic or neurological condition of hip and knee
- Sign and symptoms of lower motor neuron disease
- Current use of medication
- Radiculopathy
- Fracture
- Malignancy
- Thromboembolism
- Decreased range of motion
Trial locations and contacts
2 sites in 1 country.
Pakistan2 sites
Gulberg Medical Complex
Islamabad, Federal, 44000
Medcity International Hospital
Islamabad, Federal, 44000
About this study
Official title: Effects of Blood Flow Restriction Training vs Traditional Exercise in Patients With Knee Osteoarthritis.
The main objective of the study is to compare the effects of Blood flow Restriction training vs. traditional exercises on knee pain , knee functional disability and on quadriceps strength in patient with knee osteoarthritis.
Read the detailed description
Osteoarthritis is a degenerative disease affecting the most commonly weight bearing joint.The common form of arthritis is osteoarthritis (OA) causing structural changes in the joint. Age is a common factor affecting the strength and muscle mass.Worldwide there is a drastic increase of osteoarthritis in the older population. In the past 20 years the prevalence of knee pain increased and reached up to 50% in the older population. The most common OA affecting lower extremity is in the knee Joint.Majority of the people affected by knee OA are the older population. Knee Joints being the most weight bearing joint affected in OA causing pain , limiting function and mobility.Mobility and function may be affected in osteoarthritic population usually experience pain and stiffness.
The main objective of this study is to compare the Effects of blood Flow restriction training vs conventional treatment exercises on knee pain, functional disability and quadriceps strengthening.
The main purpose of this study is to improve the muscular strength of lower limbs which are being affected in a disease osteoarthritis in the adult population.
- Conditions
- Osteoarthritis, Knee, Hypertrophy
- Being tested
- Blood flow Restriction/Resistance Training, Conventional Therapy Group
- Keywords
- Osteoarthritis, Blood Flow Restriction, Quadriceps, Resistance Training
- Medical subject headings
- Osteoarthritis, Knee, Hypertrophy, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood flow Restriction/Resistance TrainingOther
During each exercise, only blood flow in the involved leg was restricted using an aneroid sphygmomanometer. Prior to exercise the cuff was placed on the most proximal portion of the limb and limb occlusion pressure (LOP) was calculated in the body position that the Blood flow Restriction (BFR) stimulus would be applied. Blood Flow Restriction BFR pressure was set at 50% occlusion. Resistance applied for 1 minute (60 sec) with 30 % load of 1 repetition maximum. Subjects will receive treatment bilaterally. Participants will perform exercises 2 sets with 15 repetitions through 0 to 90 degrees.
Conventional Therapy GroupOther
Resistance applied for 1 minute (60 sec) with 30 % load of 1 repetition maximum. Subjects will receive treatment bilaterally.participants will perform 2 sets with 15 repetitions in (0 to 90 degree.)
| Study group | Role | What they receive |
|---|---|---|
| Resistance exercise group | Experimental | During each exercise, only blood flow in the involved leg was restricted using an aneroid sphygmomanometer. Prior to exercise the cuff was placed on the most proximal portion of the limb and LOP was calculated in the body position that the blood flow restriction (BFR) stimulus would be applied. BFR pressure was set at 50% occlusion.Resistance applied for 1 minute (60 sec) with 30 % load of 1 repetition maximum. Subjects will receive treatment bilaterally.Participants will perform exercises 2 sets with 15 repetitions through 0 to 90 degrees.
Secondly, Rest between sets (1 min) Therapist will help these positions to maintain Knee extension and Wall Squatting.
The study includes interventional protocol of 6 weeks. Total sessions will be 12 and in each week there will 2 sessions with alternative days and follow up. Receives: Other: Blood flow Restriction/Resistance Training |
| Conventional Therapy Group | Active comparator | Patients in this group will receive treatment via Knee extension,Wall squatting Each training session includes 3 minutes warm-up.First, participants will perform 2 sets with 15 repetitions in (0 to 90 degree.) Secondly, Rest between sets (1 min) Resistance applied for 1 minute (60 sec) with 30 % load of 1 repetition maximum. Subjects will receive treatment bilaterally. The study includes interventional protocol of 6 weeks. The sessions will be given on 2 alternate days making it a total of 12 sessions and then follow up. Receives: Other: Conventional Therapy Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle strength
Measurement of Quadriceps strength with portable weight machine.
Measured: 6 weeks
Thigh Girth
Participants will be supine lying and knee in extension, standing or knee at 90 degree. Proximal to the patellar pole superiorly one measurement with a non-elastic tape at the inguinal fold, then mark the mid-point at the mid-thigh level measuring in centimeters/inches.
Measured: 6 weeks
Numeric Pain Rating Scale ( NPRS)
Patient will be asked if there is any pain in knee from the scale of 0 to 10.
Measured: 6 weeks
Q angle Measurement
Subject will be in supine position with knee extension and quadriceps are relaxed, examiner will measure the q angle with flexible inch tape and goniometer. The Q- angle is measured by extending a line through the center of the patella to the anterior superior iliac spine and another line from the tibial tubercle through the center of the patella.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2021
- Study start10 Oct 2021
- Primary completion11 Feb 2022
- Study completion11 Feb 2022
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 Riphah International UniversityThe 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
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Saad Rauf, Master, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05058794
- Sponsor's protocol ID
- REC/00947 Farah Anwar
- Status last verified
- Mar 2022
- First submitted
- 17 Sep 2021
- Last updated
- 23 Mar 2022
- 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 23 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Blood Flow Restriction Training vs Traditional Exercise in Patients With Knee Osteoarthritis.
- ClinicalTrials.gov ID
- NCT05058794
- Acronym / sponsor ID
- REC/00947 Farah Anwar
- Conditions
- Osteoarthritis, Knee, Hypertrophy
- Keywords
- Osteoarthritis, Blood Flow Restriction, Quadriceps, Resistance Training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 10 Oct 2021 (actual)
- Primary completion
- 11 Feb 2022 (actual)
- Study completion
- 11 Feb 2022 (actual)
- First posted
- 28 Sep 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.
The main objective of the study is to compare the effects of Blood flow Restriction training vs. traditional exercises on knee pain , knee functional disability and on quadriceps strength in patient with knee osteoarthritis.
Detailed description
Osteoarthritis is a degenerative disease affecting the most commonly weight bearing joint.The common form of arthritis is osteoarthritis (OA) causing structural changes in the joint. Age is a common factor affecting the strength and muscle mass.Worldwide there is a drastic increase of osteoarthritis in the older population. In the past 20 years the prevalence of knee pain increased and reached up to 50% in the older population. The most common OA affecting lower extremity is in the knee Joint.Majority of the people affected by knee OA are the older population. Knee Joints being the most weight bearing joint affected in OA causing pain , limiting function and mobility.Mobility and function may be affected in osteoarthritic population usually experience pain and stiffness.
The main objective of this study is to compare the Effects of blood Flow restriction training vs conventional treatment exercises on knee pain, functional disability and quadriceps strengthening.
The main purpose of this study is to improve the muscular strength of lower limbs which are being affected in a disease osteoarthritis in the adult population.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Resistance exercise group | Experimental | Other: Blood flow Restriction/Resistance TrainingDuring each exercise, only blood flow in the involved leg was restricted using an aneroid sphygmomanometer. Prior to exercise the cuff was placed on the most proximal portion of the limb and LOP was calculated in the body position that the blood flow restriction (BFR) stimulus would be applied. BFR pressure was set at 50% occlusion.Resistance applied for 1 minute (60 sec) with 30 % load of 1 repetition maximum. Subjects will receive treatment bilaterally.Participants will perform exercises 2 sets with 15 repetitions through 0 to 90 degrees. Secondly, Rest between sets (1 min) Therapist will help these positions to maintain Knee extension and Wall Squatting. The study includes interventional protocol of 6 weeks. Total sessions will be 12 and in each week there will 2 sessions with alternative days and follow up. |
| Conventional Therapy Group | Active comparator | Other: Conventional Therapy GroupPatients in this group will receive treatment via Knee extension,Wall squatting Each training session includes 3 minutes warm-up.First, participants will perform 2 sets with 15 repetitions in (0 to 90 degree.) Secondly, Rest between sets (1 min) Resistance applied for 1 minute (60 sec) with 30 % load of 1 repetition maximum. Subjects will receive treatment bilaterally. The study includes interventional protocol of 6 weeks. The sessions will be given on 2 alternate days making it a total of 12 sessions and then follow up. |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Pain : Subjects having unilateral or bilateral pain
- Pain type : subjects having chronic pain
- Includes diagnosed cases of knee osteoarthritis
- grades 2-3 according to the Kellgren and Lawrence method of grading
- Includes knee osteoarthritis patients with lateral tracking of patella which will assessed through Q angle test
Key exclusion criteria (8 listed)
- Any other orthopaedic or neurological condition of hip and knee
- Sign and symptoms of lower motor neuron disease
- Current use of medication
- Radiculopathy
- Fracture
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 |
|---|---|---|
| Blood flow Restriction/Resistance TrainingDuring each exercise, only blood flow in the involved leg was restricted using an aneroid sphygmomanometer. Prior to exercise the cuff was placed on the most proximal portion of the limb and limb occlusion pressure (LOP) was calculated in the body position that the Blood flow Restriction (BFR) stimulus would be applied. Blood Flow Restriction BFR pressure was set at 50% occlusion. Resistance applied for 1 minute (60 sec) with 30 % load of 1 repetition maximum. Subjects will receive treatment bilaterally. Participants will perform exercises 2 sets with 15 repetitions through 0 to 90 degrees. | Other | Resistance exercise group |
| Conventional Therapy GroupResistance applied for 1 minute (60 sec) with 30 % load of 1 repetition maximum. Subjects will receive treatment bilaterally.participants will perform 2 sets with 15 repetitions in (0 to 90 degree.) | Other | Conventional Therapy Group |
Primary outcome
Muscle strength
Time frame: 6 weeks
Measurement of Quadriceps strength with portable weight machine.
Thigh Girth
Time frame: 6 weeks
Participants will be supine lying and knee in extension, standing or knee at 90 degree. Proximal to the patellar pole superiorly one measurement with a non-elastic tape at the inguinal fold, then mark the mid-point at the mid-thigh level measuring in centimeters/inches.
Numeric Pain Rating Scale ( NPRS)
Time frame: 6 weeks
Patient will be asked if there is any pain in knee from the scale of 0 to 10.
Q angle Measurement
Time frame: 6 weeks
Subject will be in supine position with knee extension and quadriceps are relaxed, examiner will measure the q angle with flexible inch tape and goniometer. The Q- angle is measured by extending a line through the center of the patella to the anterior superior iliac spine and another line from the tibial tubercle through the center of the patella.
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 23 Mar 2022.
- 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.
Saad Rauf, Master principal investigator
Riphah International University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood flow Restriction/Resistance Training and Conventional Therapy Group in people with Osteoarthritis, Knee and Hypertrophy, run by Riphah International University at 2 sites 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 5 inclusion and 8 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 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Muscle strength (time frame: 6 weeks). 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?
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 Mar 2022.