Knee OsteoarthritisPBFRNCT01311206
Low Intensity Resistance Training With Partial Blood Flow Restriction for Quadriceps Strengthening
A study testing partial blood flow restriction and Low intensity exercise without partial blood flow restriction in people with Knee Osteoarthritis and Symptomatic Knee Osteoarthritis, run by University of Iowa at 1 site in United States.
Trial summary
The objective of the proposed research is to assess the efficacy of an eight-week, efficient and tolerable, low-intensity resistance-training program with concurrent application of partial blood flow restriction (PBFR) for improving quadriceps strength and volume in women with risk factors for incident symptomatic or… 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
- Knee Osteoarthritis, Symptomatic Knee Osteoarthritis
- What is being tested?
- partial blood flow restriction and Low intensity exercise without partial blood flow restriction
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2011to Jun 2011
- 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
- Female
- Age 45-60
- BMI less than 37 and greater than or equal to 25 kg/m2, or a history of a knee joint injury or surgery, or knee symptoms (pain, aching, or stiffness) on most of the last 30 days, or knee osteoarthritis
Who cannot join
- Resistance training at any time in the last 3 months prior to study
- 5° malalignment of a knee
- Bilateral knee replacement
- Lower limb amputation
- Lower limb surgery in the last 6 months that affects walking ability or ability to exercise
- Back, hip or knee problems that affect walking ability or ability to exercise
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- Unable to walk without a cane or walker
- Unable to ascend at least 2 stairs (to enter our building)
- Inflammatory joint or muscle disease such as rheumatoid or psoriatic arthritis or polymyalgia rheumatica
- Multiple sclerosis
- Known neuropathy
- Self-report of Diabetes
- Currently being treated for cancer or having untreated cancer
- Terminal illness (cannot be cured or adequately treated and there is a reasonable expectation of death in the near future)
- Peripheral Vascular Disease
- History of myocardial infarction or stroke in the last year
- Deep Venous Thrombosis
- Chest pain during exercise or at rest
- Use of supplemental oxygen
- Inability to follow protocol (e.g. lack of ability to attend visits or understand instructions)
- Staff concern for subject health (such as history of dizziness/faintness or current restrictions on activity)
- Concurrent study participation (such as the MOST study)
- Planning to be away for more than one week during the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Determining Efficacy of a Tolerable Means of Strengthening for Older Adults With Knee Osteoarthritis: Partial Blood Flow Restriction Low Intensity Resistance Training
The objective of the proposed research is to assess the efficacy of an eight-week, efficient and tolerable, low-intensity resistance-training program with concurrent application of partial blood flow restriction (PBFR) for improving quadriceps strength and volume in women with risk factors for incident symptomatic or progressive knee OA. This specific aim will be achieved through a randomized, controlled trial, comparing low intensity training with and without PBFR. There have been numerous reports of exercise interventions in people with knee osteoarthritis. However, this research is novel in that it will be the first to use a low intensity regimen that will minimize forces on the knee while still having the potential to lead to clinically meaningful strength gains in older adults with risk factors for incident symptomatic or progressive knee OA.
- Being tested
- partial blood flow restriction, Low intensity exercise without partial blood flow restriction
- Keywords
- knee osteoarthritis, isokinetic knee extensor strength, quadriceps volume, symptomatic knee osteoarthritis
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
partial blood flow restrictionOther
Partial Blood Flow Restriction (PBFR) Low-Intensity Exercise: using the Biodex 3 Dynamometer in isotonic mode at 10% (first 3 weeks), 15% (following 3 weeks) and 20% (final 3 weeks) of their 1RM for each side, while receiving PBFR in each exercising limb. The padded belts (65 mm in width and 650 mm in length) of the Kaatsu Master™ PBFR device (Sato Sports Plaza, Tokyo, Japan) will be applied to the proximal thigh as near to the hip joint as is comfortable. Before training each leg, subjects will be seated in a chair where an initial belt pressure of 37-40 mmHg will be applied. The belt then will be iteratively pressurized for 30 seconds and then relaxed for 10 seconds in increments of 20 mmHg from 100 mmHg to the final pressure of 160 mmHg. During exercise, the cuff pressure will be continuously controlled and monitored by the PBFR apparatus
Low intensity exercise without partial blood flow restrictionOther
Low-Intensity Exercise: using the Biodex 3 Dynamometer in isotonic mode at 10% (first 3 weeks), 15% (following 3 weeks) and 20% (final 3 weeks) of their 1RM for each side in each exercising limb without partial blood flow restriction.
| Study group | Role | What they receive |
|---|---|---|
| PBFR | Experimental | Partial Blood Flow Restriction (PBFR) during Low-Intensity Exercise. Receives: Other: partial blood flow restriction |
| PBFR control | Active comparator | Low-Intensity Exercise without partial blood flow restriction. Receives: Other: Low intensity exercise without partial blood flow restriction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in isokinetic knee extensor strength after 9-week intervention
This outcome will measure efficacy of 9-week intervention.
Measured: Outcome will be measured at week 0 (baseline) and approximately 10 weeks later (after completion of 9-week intervention)
Secondary outcomes (1)
Change in quadriceps volume assessed by MRI after completion of 9-week intervention
This outcome will measure efficacy of the 9-week intervention.
Measured: outcome will be measured at week 0 and at approximately week 10 (after completion of 9-week intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2011 (estimated)
- Study startFeb 2011
- Primary completionJun 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Iowa
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01311206
- Sponsor's protocol ID
- 201101711
- Acronym
- PBFR
- Status last verified
- Jun 2011
- First submitted
- 22 Feb 2011
- Last updated
- 28 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determining Efficacy of a Tolerable Means of Strengthening for Older Adults With Knee Osteoarthritis: Partial Blood Flow Restriction Low Intensity Resistance Training
- ClinicalTrials.gov ID
- NCT01311206
- Acronym / sponsor ID
- PBFR / 201101711
- Keywords
- knee osteoarthritis, isokinetic knee extensor strength, quadriceps volume, symptomatic knee osteoarthritis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of IowaUniversity, hospital or other
- Study start
- Feb 2011
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 9 Mar 2011 (estimated)
- 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 objective of the proposed research is to assess the efficacy of an eight-week, efficient and tolerable, low-intensity resistance-training program with concurrent application of partial blood flow restriction (PBFR) for improving quadriceps strength and volume in women with risk factors for incident symptomatic or progressive knee OA. This specific aim will be achieved through a randomized, controlled trial, comparing low intensity training with and without PBFR. There have been numerous reports of exercise interventions in people with knee osteoarthritis. However, this research is novel in that it will be the first to use a low intensity regimen that will minimize forces on the knee while still having the potential to lead to clinically meaningful strength gains in older adults with risk factors for incident symptomatic or progressive knee OA.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PBFR | Experimental | Other: partial blood flow restrictionPartial Blood Flow Restriction (PBFR) during Low-Intensity Exercise. |
| PBFR control | Active comparator | Other: Low intensity exercise without partial blood flow restrictionLow-Intensity Exercise without partial blood flow restriction. |
Who may qualify
- Ages
- 45 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Female
- Age 45-60
- BMI less than 37 and greater than or equal to 25 kg/m2, or a history of a knee joint injury or surgery, or knee symptoms (pain, aching, or stiffness) on most of the last 30 days, or knee osteoarthritis
Key exclusion criteria (23 listed)
- Resistance training at any time in the last 3 months prior to study
- 5° malalignment of a knee
- Bilateral knee replacement
- Lower limb amputation
- Lower limb surgery in the last 6 months that affects walking ability or ability to exercise
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 |
|---|---|---|
| partial blood flow restrictionPartial Blood Flow Restriction (PBFR) Low-Intensity Exercise: using the Biodex 3 Dynamometer in isotonic mode at 10% (first 3 weeks), 15% (following 3 weeks) and 20% (final 3 weeks) of their 1RM for each side, while receiving PBFR in each exercising limb. The padded belts (65 mm in width and 650 mm in length) of the Kaatsu Master™ PBFR device (Sato Sports Plaza, Tokyo, Japan) will be applied to the proximal thigh as near to the hip joint as is comfortable. Before training each leg, subjects will be seated in a chair where an initial belt pressure of 37-40 mmHg will be applied. The belt then will be iteratively pressurized for 30 seconds and then relaxed for 10 seconds in increments of 20 mmHg from 100 mmHg to the final pressure of 160 mmHg. During exercise, the cuff pressure will be continuously controlled and monitored by the PBFR apparatus | Other | PBFR |
| Low intensity exercise without partial blood flow restrictionLow-Intensity Exercise: using the Biodex 3 Dynamometer in isotonic mode at 10% (first 3 weeks), 15% (following 3 weeks) and 20% (final 3 weeks) of their 1RM for each side in each exercising limb without partial blood flow restriction. | Other | PBFR control |
Primary outcome
Change in isokinetic knee extensor strength after 9-week intervention
Time frame: Outcome will be measured at week 0 (baseline) and approximately 10 weeks later (after completion of 9-week intervention)
This outcome will measure efficacy of 9-week intervention.
1 secondary outcome
Change in quadriceps volume assessed by MRI after completion of 9-week intervention
Time frame: outcome will be measured at week 0 and at approximately week 10 (after completion of 9-week intervention)
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 28 Jun 2011.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing partial blood flow restriction and Low intensity exercise without partial blood flow restriction in people with Knee Osteoarthritis and Symptomatic Knee Osteoarthritis, run by University of Iowa at 1 site in United States.
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 23 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 28 Jun 2011. 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 United States. 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?
Change in isokinetic knee extensor strength after 9-week intervention (time frame: Outcome will be measured at week 0 (baseline) and approximately 10 weeks later (after completion of 9-week intervention)). 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 28 Jun 2011.