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CompletedNCT01311206PBFRUpdated Jun 28, 2011

Low Intensity Resistance Training With Partial Blood Flow Restriction for Quadriceps Strengthening

An interventional study of partial blood flow restriction and Low intensity exercise without partial blood flow restriction in Knee Osteoarthritis and Symptomatic Knee Osteoarthritis, sponsored by University of Iowa. Completed at 1 site in United States. Open to female participants aged 45 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2011-06-28.

Sponsored by University of Iowa · Not applicable and Interventional

Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
45 Years to 60 Years
Sex
Female
01

Study 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.

02

Conditions studied

  • Knee Osteoarthritis
  • Symptomatic Knee Osteoarthritis

Keywords

  • knee osteoarthritis
  • isokinetic knee extensor strength
  • quadriceps volume
  • symptomatic knee osteoarthritis
03

In context

Osteoarthritis

4,398 studies on the registry are indexed under Osteoarthritis; 582 are open to participants now.

This study's enrollment of 50 is below the median of 70 across 3,440 interventional studies indexed under Osteoarthritis.

Browse Osteoarthritis studies →

Lead sponsor

University of Iowa is the lead sponsor of 276 studies on the registry; 35 are open to participants now.

Of its 44 completed or terminated interventional studies of FDA-regulated products, 39 (89%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
45 Years to 60 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Not applicable
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
50 participants (actual)

Study arms

  • Experimental
    PBFR

    Partial Blood Flow Restriction (PBFR) during Low-Intensity Exercise.

    Other: partial blood flow restriction

  • Active comparator
    PBFR control

    Low-Intensity Exercise without partial blood flow restriction.

    Other: Low intensity exercise without partial blood flow restriction

Interventions

  • Otherpartial 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

  • OtherLow 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.

06

What researchers measure

Primary outcomes

  1. Change in isokinetic knee extensor strength after 9-week intervention

    This outcome will measure efficacy of 9-week intervention.

    Time frame: Outcome will be measured at week 0 (baseline) and approximately 10 weeks later (after completion of 9-week intervention)

Secondary outcomes

  1. Change in quadriceps volume assessed by MRI after completion of 9-week intervention

    This outcome will measure efficacy of the 9-week intervention.

    Time frame: outcome will be measured at week 0 and at approximately week 10 (after completion of 9-week intervention)

07

Study locations

1 site
  • University of Iowa
    Iowa City, Iowa 52242, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 28, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01311206
Lead sponsor
University of Iowa
First posted
Mar 9, 2011
Start date
Feb 2011
Primary completion
Jun 2011
Completion
Jun 2011
Last update
Jun 28, 2011

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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