- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01440972
Assessment of Efficacy of Low Intensity Resistance Training in Women at Risk for Symptomatic Knee Osteoarthritis (PBFR2)
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 Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
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Iowa
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Iowa City, Iowa, United States, 52242
- University of Iowa
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- 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
Study Plan
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Exercise without PBFR
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low intensity resistance training without partial blood flow restriction
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Experimental: exercise with PBFR
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low intensity resistance training with partial blood flow restriction 3 times/week for 4 weeks.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in Isotonic Double Leg-press 1 Repetition Maximum Strength Scaled to Body Mass
Time Frame: 4 weeks
|
4 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Quadriceps Muscle Volume by Magnetic Resonance Imaging
Time Frame: 4 weeks
|
4 weeks
|
|
Change in Lower Limb Muscle Power by Double Leg-press at 40% 1 Repetition Maximum
Time Frame: 4 weeks
|
4 weeks
|
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Change in Knee Injury and Osteoarthritis Outcome Score Pain Subscale
Time Frame: 4 weeks
|
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.
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4 weeks
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Change in Isokinetic Knee Extensor Strength
Time Frame: 4 weeks
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4 weeks
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Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 201109738
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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