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

Knee Osteoarthritis Clinical Trial

— PBFR2  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01440972
• Other study ID #: 201109738
• Status: Completed
• Phase: N/A
• First received: September 21, 2011
• Last updated: July 2, 2015
• Start date: September 2011
• Est. completion date: November 2011

Study information

• Verified date: July 2015
• Source: University of Iowa
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: November 2011
• Est. primary completion date: November 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 45 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor)

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee
• Symptomatic Knee Osteoarthritis

Intervention

Other:
• partial blood flow restriction (PBFR)
low intensity resistance training with partial blood flow restriction 3 times/week for 4 weeks.
• low intensity resistance training
low intensity resistance training without partial blood flow restriction

Locations

Country	Name	City	State
United States	University of Iowa	Iowa City	Iowa

Sponsors (2)

Lead Sponsor	Collaborator
University of Iowa	The American Geriatrics Society

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Isotonic Double Leg-press 1 Repetition Maximum Strength Scaled to Body Mass		4 weeks	No
Secondary	Change in Quadriceps Muscle Volume by Magnetic Resonance Imaging		4 weeks	No
Secondary	Change in Lower Limb Muscle Power by Double Leg-press at 40% 1 Repetition Maximum		4 weeks	No
Secondary	Change in Knee Injury and Osteoarthritis Outcome Score Pain Subscale	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.	4 weeks	Yes
Secondary	Change in Isokinetic Knee Extensor Strength		4 weeks	No