N/A N=45 Randomized Triple-blind

Assessment of Efficacy of Low Intensity Resistance Training in Women at Risk for Symptomatic Knee Osteoarthritis

Knee Osteoarthritis · Symptomatic Knee Osteoarthritis

Bottom Line

View on ClinicalTrials.gov: NCT01440972 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jul 2015

Primary outcome: Primary: Change in Isotonic Double Leg-press 1 Repetition Maximum Strength Scaled to Body Mass — 0.2; 0.4 kg per kg body mass

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: partial blood flow restriction (PBFR) (Other); low intensity resistance training (Other)
Age: Adult, Older Adult · 45+ yrs
Sex: Female
Sponsor: University of Iowa
Primary completion: Nov 2011

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Isotonic Double Leg-press 1 Repetition Maximum Strength Scaled to Body Mass	0.2; 0.4	—
SECONDARY Change in Quadriceps Muscle Volume by Magnetic Resonance Imaging	0.01; 1.3	—
SECONDARY Change in Lower Limb Muscle Power by Double Leg-press at 40% 1 Repetition Maximum	0.42; .62	—
SECONDARY Change in Knee Injury and Osteoarthritis Outcome Score Pain Subscale	1.8; 2.0	—
SECONDARY Change in Isokinetic Knee Extensor Strength	-0.05; .07	—

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 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: 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

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01440972). 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.