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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
  Purpose

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.


Condition Intervention
Knee Osteoarthritis
Symptomatic Knee Osteoarthritis
Other: partial blood flow restriction
Other: Low intensity exercise without partial blood flow restriction

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Official Title: Determining Efficacy of a Tolerable Means of Strengthening for Older Adults With Knee Osteoarthritis: Partial Blood Flow Restriction Low Intensity Resistance Training

Resource links provided by NLM:


Further study details as provided by University of Iowa:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 50
Study Start Date: February 2011
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PBFR
Partial Blood Flow Restriction (PBFR) during Low-Intensity Exercise.
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
Active Comparator: PBFR control
Low-Intensity Exercise without partial blood flow restriction.
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.

  Eligibility

Ages Eligible for Study:   45 Years to 60 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01311206

Locations
United States, Iowa
University of Iowa
Iowa City, Iowa, United States, 52242
Sponsors and Collaborators
University of Iowa
  More Information

No publications provided

Responsible Party: Neil A. Segal, MD, MS, University of Iowa
ClinicalTrials.gov Identifier: NCT01311206     History of Changes
Other Study ID Numbers: 201101711
Study First Received: February 22, 2011
Last Updated: June 27, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by University of Iowa:
knee osteoarthritis
isokinetic knee extensor strength
quadriceps volume
symptomatic knee osteoarthritis

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on November 24, 2014