Clinical trial NCT01311206: Low Intensity Resistance Training With Partial Blood Flow Restriction for Quadriceps Strengthening
Official title: Determining Efficacy of a Tolerable Means of Strengthening for Older Adults With Knee Osteoarthritis: Partial Blood Flow Restriction Low Intensity Resistance Training
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Knee Osteoarthritis
Symptomatic Knee Osteoarthritis
Keywords: knee osteoarthritis
isokinetic knee extensor strength
quadriceps volume
symptomatic knee osteoarthritis
Lead sponsor: University of Iowa
Sponsor class: OTHER
First posted: 2011-03-09
Enrollment: 50
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in isokinetic knee extensor strength after 9-week intervention
timeFrame: Outcome will be measured at week 0 (baseline) and approximately 10 weeks later (after completion of 9-week intervention)
Secondary outcomes:
measure: Change in quadriceps volume assessed by MRI after completion of 9-week intervention
timeFrame: outcome will be measured at week 0 and at approximately week 10 (after completion of 9-week intervention)
Other outcomes:
Locations:
city: Iowa City
country: United States
facility: University of Iowa
state: Iowa
Study officials:
References: