Knee OsteoarthritisPBFR2NCT01440972
Assessment of Efficacy of Low Intensity Resistance Training in Women at Risk for Symptomatic Knee Osteoarthritis
A study testing partial blood flow restriction (PBFR) and low intensity resistance training in people with Knee Osteoarthritis and Symptomatic Knee Osteoarthritis, run by University of Iowa at 1 site in United States.
Trial summary
The purpose of this study is to asses the efficacy of a 4 week low-intensity resistance training program with concurrent application of partial blood flow restriction (PBFR) to the exercising limbs to improve quadriceps strength and size, leg muscle power, and mobility in women at risk for developing symptomatic knee… Read more about this study
- Who is it for?
- Ages 45 to 65 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 (PBFR) and low intensity resistance training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2011to Nov 2011
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Female
- Age 45-65
- BMI 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
- 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
- Unable to walk without a cane or walker
Show all 21Show fewer
- 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
- History of 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)
- Unable to attend more than 2 days within any 1 week or unable to attend 4 or more sessions during the study
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to asses the efficacy of a 4 week low-intensity resistance training program with concurrent application of partial blood flow restriction (PBFR) to the exercising limbs to improve quadriceps strength and size, leg muscle power, and mobility in women at risk for developing symptomatic knee osteoarthritis. The primary outcome will be change in isotonic double leg-press 1 repetition maximum (1RM) strength. The investigators will test the following hypotheses. In comparison with low-intensity resistance training without use of PBFR, a four-week low-intensity resistance-training program with PBFR will:
Primary Hypothesis: Increase (a) double leg-press 1RM strength and (b) isokinetic knee extensor strength
Read more
Secondary Hypotheses:
- Increase quadriceps muscle volume assessed by MRI
- Increase lower limb muscle power on (a) double leg-press at 40% 1RM and (b) a timed stair climb
- Not adversely effect knee pain or quality of life assessed by the Knee injury and Osteoarthritis Outcome Score (KOOS) questionnaire
- Being tested
- partial blood flow restriction (PBFR), low intensity resistance training
- Keywords
- knee osteoarthritis, symptomatic knee osteoarthritis, isotonic leg-press strength, isokinetic knee extensor strength, quadriceps volume
- 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 restriction (PBFR)Other
low intensity resistance training with partial blood flow restriction 3 times/week for 4 weeks.
low intensity resistance trainingOther
low intensity resistance training without partial blood flow restriction
| Study group | Role | What they receive |
|---|---|---|
| Exercise without PBFR | Active comparator | Not described Receives: Other: low intensity resistance training |
| exercise with PBFR | Experimental | Not described Receives: Other: partial blood flow restriction (PBFR) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Isotonic Double Leg-press 1 Repetition Maximum Strength Scaled to Body Mass
Measured: 4 weeks
Secondary outcomes (4)
Change in Quadriceps Muscle Volume by Magnetic Resonance Imaging
Measured: 4 weeks
Change in Lower Limb Muscle Power by Double Leg-press at 40% 1 Repetition Maximum
Measured: 4 weeks
Change in Knee Injury and Osteoarthritis Outcome Score Pain Subscale
KOOS consists of 5 subscales; Pain, other Symptoms, Function in daily living (ADL), Function in sport and recreation (Sport/Rec) and knee related Quality of life QOL. The last week is taken into consideration when answering the questions. Standardized answer options are given (5 Likert boxes) and each question gets a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale. KOOS is patient-administered, the format is user friendly, and takes about 10 minutes to fill out. Only the pain sub scale was used for the reported study.
Measured: 4 weeks
Change in Isokinetic Knee Extensor Strength
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2011 (estimated)
- Study startSep 2011
- Primary completionNov 2011
- Study completionNov 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- More trials run by University of IowaThe 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Iowa
- Sponsor type
- University, hospital or other
- Collaborators
- The American Geriatrics Society
- Responsible party
- Principal investigator, Neil A Segal, University of Iowa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01440972
- Sponsor's protocol ID
- 201109738
- Acronym
- PBFR2
- Status last verified
- Oct 2016
- First submitted
- 21 Sep 2011
- Last updated
- 5 Dec 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Efficacy of Low Intensity Resistance Training in Women at Risk for Symptomatic Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT01440972
- Acronym / sponsor ID
- PBFR2 / 201109738
- Keywords
- knee osteoarthritis, symptomatic knee osteoarthritis, isotonic leg-press strength, isokinetic knee extensor strength, quadriceps volume
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- University of IowaUniversity, hospital or other
- Collaborators
- The American Geriatrics Society
- Study start
- Sep 2011
- Primary completion
- Nov 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 27 Sep 2011 (estimated)
- Results
- Posted 30 Jul 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to asses the efficacy of a 4 week low-intensity resistance training program with concurrent application of partial blood flow restriction (PBFR) to the exercising limbs to improve quadriceps strength and size, leg muscle power, and mobility in women at risk for developing symptomatic knee osteoarthritis. The primary outcome will be change in isotonic double leg-press 1 repetition maximum (1RM) strength. The investigators will test the following hypotheses. In comparison with low-intensity resistance training without use of PBFR, a four-week low-intensity resistance-training program with PBFR will:
Primary Hypothesis: Increase (a) double leg-press 1RM strength and (b) isokinetic knee extensor strength
Secondary Hypotheses:
- Increase quadriceps muscle volume assessed by MRI
- Increase lower limb muscle power on (a) double leg-press at 40% 1RM and (b) a timed stair climb
- Not adversely effect knee pain or quality of life assessed by the Knee injury and Osteoarthritis Outcome Score (KOOS) questionnaire
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise without PBFR | Active comparator | Other: low intensity resistance training |
| exercise with PBFR | Experimental | Other: partial blood flow restriction (PBFR) |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Female
- Age 45-65
- BMI 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 (21 listed)
- Resistance training at any time in the last 3 months prior to study
- 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
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 restriction (PBFR)low intensity resistance training with partial blood flow restriction 3 times/week for 4 weeks. | Other | exercise with PBFR |
| low intensity resistance traininglow intensity resistance training without partial blood flow restriction | Other | Exercise without PBFR |
Primary outcome
Change in Isotonic Double Leg-press 1 Repetition Maximum Strength Scaled to Body Mass
Time frame: 4 weeks
4 secondary outcomes
Change in Quadriceps Muscle Volume by Magnetic Resonance Imaging
Time frame: 4 weeks
Change in Lower Limb Muscle Power by Double Leg-press at 40% 1 Repetition Maximum
Time frame: 4 weeks
Change in Knee Injury and Osteoarthritis Outcome Score Pain Subscale
Time frame: 4 weeks
Change in Isokinetic Knee Extensor Strength
Time frame: 4 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Knee Osteoarthritis
Not yet recruiting
Holistic Healing for Knee Osteoarthritis
Knee Osteoarthritis (Knee OA)
Recruiting
Effect of Anti-inflammatory Diet in Osteoarthritis
Osteoarthritis, Knee
Active, not recruitingPhase 2/3
Single vs Triple Hyaluronic Acid in Knee Osteoarthritis
Osteoarthritis, Knee
Not yet recruiting
The Feasibility of a Virtual/Home-based OA Treatment Program in Older Adults With OA and Multimorbidity
Osteoarthritis of the Knee
RecruitingObservational study
Exploring Factors Linked to Worsening Over Time in People With Early-stage Knee Osteoarthritis and Those With Prior Proven Acute Knee Injury.
Knee Osteoarthritis
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 (PBFR) and low intensity resistance training 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 21 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 5 Dec 2016. 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?
Yes. Results are posted in the registry (first posted 30 Jul 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Isotonic Double Leg-press 1 Repetition Maximum Strength Scaled to Body Mass (time frame: 4 weeks). 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 5 Dec 2016.