N/A
N=42
Assessment of Efficacy of Low Intensity Resistance Training in Men at Risk for Symptomatic Knee Osteoarthritis
Knee Osteoarthritis
Bottom Line
View on ClinicalTrials.gov: NCT01487525 ↗Enrolled (actual)
42
Serious AEs
0.0%
Results posted
Feb 2016
Primary outcome: Primary: Change in Isotonic Leg Press 1RM — 4.7; 3.1 percent change
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Double leg press with partial blood flow restriction (Device); Double leg press without partial blood flow restriction (Other)
- Age
- Adult, Older Adult · 45+ yrs
- Sex
- Male
- Sponsor
- University of Iowa
- Primary completion
- Feb 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Isotonic Leg Press 1RM |
4.7; 3.1 | — |
| SECONDARY Isokinetic Knee Extensor Strength |
6.7; 0.4 | — |
| SECONDARY Knee Pain |
14.2; 4.9 | — |
Summary
The purpose of this research study is to determine whether low intensity resistance training with concurrent application of a peripheral blood flow restriction device to the exercising limb will elicit increased quadriceps strength, functional gains, ability to complete knee-related activities of daily living, mobility, and quality of life in individuals at risk for developing symptomatic knee osteoarthritis (OA). It is known that higher quadriceps strength is protective against developing symptomatic knee OA.1 However, people at risk for knee OA frequently do not tolerate the high intensity resistance training that is generally believed necessary to increase muscle strength. Partial blood flow restriction (PBFR) to the exercising muscle has been reported to result in strength gains, while requiring lower levels of joint loading.2 This method may be better tolerated, enabling efficacious exercise in older adults who may not tolerate high knee joint loads.
To asses the efficacy of a 4 week low-intensity resistance training program with concurrent application of PBFR to the exercising limbs to improve quadriceps strength and size, leg muscle power, and mobility in individuals at risk for developing symptomatic knee osteoarthritis,we 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:
1. Increase quadriceps muscle volume assessed by MRI
2. Increase lower limb muscle power on (a) double leg-press at 40% 1RM and (b) a timed stair climb
3. Not adversely effect knee pain or quality of life assessed by the Knee injury and Osteoarthritis Outcome Score (KOOS) questionnaire
Eligibility Criteria
Inclusion Criteria
- male
- ≥ 45 years
- has at least one of the following: BMI≥25, frequent knee symptoms on most of the last 30 days, history of knee injury which rendered individual unable to walk without assistance for at least 2 days, history of knee surgery, diagnosis of 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
- Unable to attend more than 2 days within any 1 week or unable to attend 4 or more sessions during the study
Data sourced from ClinicalTrials.gov (NCT01487525). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.