Low Intensity Resistance Training With Partial Blood Flow Restriction for Quadriceps Strengthening (PBFR)

This study has been completed.

Sponsor:

Information provided by:

University of Iowa

ClinicalTrials.gov Identifier:

NCT01311206

First received: February 22, 2011

Last updated: June 27, 2011

Last verified: June 2011

History of Changes

Tracking Information
First Received Date ^ICMJE	February 22, 2011
Last Updated Date	June 27, 2011
Start Date ^ICMJE	February 2011
Primary Completion Date	June 2011 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: March 7, 2011)	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) ] [ Designated as safety issue: No ] This outcome will measure efficacy of 9-week intervention.
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01311206 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: March 7, 2011)	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) ] [ Designated as safety issue: No ] This outcome will measure efficacy of the 9-week intervention.
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Low Intensity Resistance Training With Partial Blood Flow Restriction for Quadriceps Strengthening
Official Title ^ICMJE	Determining Efficacy of a Tolerable Means of Strengthening for Older Adults With Knee Osteoarthritis: Partial Blood Flow Restriction Low Intensity Resistance Training
Brief 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 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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Outcomes Assessor)
Condition ^ICMJE	Knee Osteoarthritis Symptomatic Knee Osteoarthritis
Intervention ^ICMJE	Other: partial blood flow restriction 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 Other: Low intensity exercise without partial blood flow restriction 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 Arm (s)	Experimental: PBFR Partial Blood Flow Restriction (PBFR) during Low-Intensity Exercise. Intervention: Other: partial blood flow restriction Active Comparator: PBFR control Low-Intensity Exercise without partial blood flow restriction. Intervention: Other: Low intensity exercise without partial blood flow restriction
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	50
Completion Date	June 2011
Primary Completion Date	June 2011 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: 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 Exclusion Criteria: 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 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
Gender	Female
Ages	45 Years to 60 Years
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT01311206
Other Study ID Numbers ^ICMJE	201101711
Has Data Monitoring Committee	No
Responsible Party	Neil A. Segal, MD, MS, University of Iowa
Study Sponsor ^ICMJE	University of Iowa
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	University of Iowa
Verification Date	June 2011
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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