Knee OsteoarthritisKAATSU-OANCT02132715
KAATSU Training to Enhance Physical Function of Older Adults With Osteoarthritis
A study testing Resistance Exercise and KAATSU exercise in people with Knee Osteoarthritis, run by University of Florida at 1 site in United States.
Trial summary
As the U.S. population ages and the prevalence of osteoarthritis (OA) among older adults rises, the prevention of OA-associated disability is an important public health priority. Accordingly, efficacious interventions are needed to manage pain and maintain physical function among older adults with OA. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Resistance Exercise and KAATSU exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2014to Jul 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 60 years and older
- Radiographic evidence of osteophytes
- Moderate to severe pain score (41-90 mm) recorded on 100-mm visual analog scale after 50-ft walk
- Bilateral standing anterior-posterior radiograph demonstrating Kellgren and Lawrence grade 2 or 3
- OA of the target knee
- Score ≤ 10 on the Short Physical Performance Battery, as an indicator of physical limitation
- Sedentary lifestyle, defined as <150 min/wk of moderate physical activity as assessed by CHAMPS questionnaire
- Willingness to participate in all study procedures
Who cannot join
- Failure to provide informed consent;
- Regular participation in resistance exercise training within the past 3 months
- Current involvement in supervised rehabilitation program
- Absolute contraindication(s) to exercise training according to American College of Sports Medicine guidelines
- Diagnosed peripheral vascular disease
- Ankle-brachial index < 0.95
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- Resting office systolic blood pressure > 160 mm Hg or < 100 mm Hg
- Diastolic blood pressure > 100 mm Hg
- History or family history of thrombosis
- Resistant hypertension, defined by BP > 140/90 despite use of 3 or more antihypertensive medications
- Severe cardiac disease, including New York Heart Association Class III or IV congestive heart failure, clinically significant aortic stenosis, history of cardiac arrest or stroke, use of a cardiac defibrillator, or uncontrolled angina
- Deep venous thrombosis
- Known peripheral neuropathy
- History of rheumatoid arthritis
- Lower limb amputation
- Lives in a nursing home; (persons living in assisted or independent housing will not be excluded)
- Significant cognitive impairment, defined as a known diagnosis of dementia or a Mini-Mental State Examination exam score < 24
- Unable to communicate because of severe hearing loss or speech disorder;
- Severe visual impairment, which would preclude completion of the assessments and/or intervention
- Other significant co-morbid disease that would impair ability to participate in the exercise intervention
- Lives outside of the study site or is planning to move out of the area during the study timeframe
- Simultaneous participation in another intervention trial
Trial locations and contacts
1 site in 1 country.
About this study
As the U.S. population ages and the prevalence of osteoarthritis (OA) among older adults rises, the prevention of OA-associated disability is an important public health priority. Accordingly, efficacious interventions are needed to manage pain and maintain physical function among older adults with OA. Because skeletal muscle weakness is a primary contributory factor to the progression of pain and functional decline among persons with OA, optimal interventions are those capable of improving skeletal muscle strength. High-intensity resistance exercise is the best-known method of improving muscle strength; however high-compressive loads typically induce significant joint pain among persons with OA. Accordingly, current recommendations include the performance of low- or moderate-intensity physical exercise - despite the fact that these training paradigms are sub-optimal for enhancing muscle strength. This application proposes conduct a pilot study to investigate the potential of an innovative training paradigm with potential to stimulate improvements in skeletal muscle strength while utilizing low-intensity loads. This paradigm, known as KAATSU training, involves performing low-intensity exercise while externally-applied compression mildly restricts blood flow to the active skeletal muscle. The overarching objective of the present application is to evaluate the efficacy and feasibility of chronic KAATSU training for the improvement of skeletal muscle strength and physical function among persons aged > 60 years with symptomatic knee OA and mild to moderate physical limitations. Up to 72 participants will be recruited to participate in this three month intervention study. Participants will be randomly assigned to one of two intervention conditions: (1) a standard exercise intervention consisting of center-based, moderate-intensity resistance training, or (2) a KAATSU training program matched for overall workload. This study will provide novel information regarding the therapeutic potential of KAATSU training for improving strength and function as well as attenuating pain among these individuals. The study will also provide critical information regarding the long-term, clinical viability of the paradigm by evaluating participant safety, discomfort, and willingness to continually engage in the KAATSU training program.
- Conditions
- Knee Osteoarthritis
- Being tested
- Resistance Exercise, KAATSU exercise
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resistance ExerciseBehavioural
KAATSU exerciseBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Resistance exercise | Active comparator | Traditional isotonic lower-extremity resistance training Receives: Behavioral: Resistance Exercise |
| KAATSU exercise | Experimental | Lower-extremity exercise with blood flow mildly restricted Receives: Behavioral: KAATSU exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in isokinetic muscle strength
Measured: 6 weeks post-randomization, 12 weeks post-randomization
Secondary outcomes (4)
Change in Short Physical Performance Battery score
Measured: 12-weeks post-randomization
Change in self-paced walking speed
Measured: 6 weeks-post randomization, 12 weeks post-randomization
Change in Late Life Disability Questionnaire score
Measured: 12 weeks post-randomization
Change in Western Ontario and McMaster Osteoarthritis Index score
Measured: 12 weeks post-randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2014 (estimated)
- Study startSep 2014
- Primary completionJul 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Responsible party
- Sponsor
- Investigators
- Thomas Buford, PhD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02132715
- Sponsor's protocol ID
- IRB201400300
- Other IDs
- 1R21AR065039-01A1
- Acronym
- KAATSU-OA
- Status last verified
- Apr 2016
- First submitted
- 30 Apr 2014
- Last updated
- 23 Aug 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- KAATSU Training to Enhance Physical Function of Older Adults With Osteoarthritis
- ClinicalTrials.gov ID
- NCT02132715
- Acronym / sponsor ID
- KAATSU-OA / IRB201400300
- Conditions
- Knee Osteoarthritis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Study start
- Sep 2014
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 7 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
As the U.S. population ages and the prevalence of osteoarthritis (OA) among older adults rises, the prevention of OA-associated disability is an important public health priority. Accordingly, efficacious interventions are needed to manage pain and maintain physical function among older adults with OA. Because skeletal muscle weakness is a primary contributory factor to the progression of pain and functional decline among persons with OA, optimal interventions are those capable of improving skeletal muscle strength. High-intensity resistance exercise is the best-known method of improving muscle strength; however high-compressive loads typically induce significant joint pain among persons with OA. Accordingly, current recommendations include the performance of low- or moderate-intensity physical exercise - despite the fact that these training paradigms are sub-optimal for enhancing muscle strength. This application proposes conduct a pilot study to investigate the potential of an innovative training paradigm with potential to stimulate improvements in skeletal muscle strength while utilizing low-intensity loads. This paradigm, known as KAATSU training, involves performing low-intensity exercise while externally-applied compression mildly restricts blood flow to the active skeletal muscle. The overarching objective of the present application is to evaluate the efficacy and feasibility of chronic KAATSU training for the improvement of skeletal muscle strength and physical function among persons aged > 60 years with symptomatic knee OA and mild to moderate physical limitations. Up to 72 participants will be recruited to participate in this three month intervention study. Participants will be randomly assigned to one of two intervention conditions: (1) a standard exercise intervention consisting of center-based, moderate-intensity resistance training, or (2) a KAATSU training program matched for overall workload. This study will provide novel information regarding the therapeutic potential of KAATSU training for improving strength and function as well as attenuating pain among these individuals. The study will also provide critical information regarding the long-term, clinical viability of the paradigm by evaluating participant safety, discomfort, and willingness to continually engage in the KAATSU training program.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Resistance exercise | Active comparator | Behavioral: Resistance ExerciseTraditional isotonic lower-extremity resistance training |
| KAATSU exercise | Experimental | Behavioral: KAATSU exerciseLower-extremity exercise with blood flow mildly restricted |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age 60 years and older
- Radiographic evidence of osteophytes
- Moderate to severe pain score (41-90 mm) recorded on 100-mm visual analog scale after 50-ft walk
- Bilateral standing anterior-posterior radiograph demonstrating Kellgren and Lawrence grade 2 or 3
- OA of the target knee
Key exclusion criteria (22 listed)
- Failure to provide informed consent;
- Regular participation in resistance exercise training within the past 3 months
- Current involvement in supervised rehabilitation program
- Absolute contraindication(s) to exercise training according to American College of Sports Medicine guidelines
- Diagnosed peripheral vascular disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Resistance Exercise | Behavioural | Resistance exercise |
| KAATSU exercise | Behavioural | KAATSU exercise |
Primary outcome
Change in isokinetic muscle strength
Time frame: 6 weeks post-randomization, 12 weeks post-randomization
4 secondary outcomes
Change in Short Physical Performance Battery score
Time frame: 12-weeks post-randomization
Change in self-paced walking speed
Time frame: 6 weeks-post randomization, 12 weeks post-randomization
Change in Late Life Disability Questionnaire score
Time frame: 12 weeks post-randomization
Change in Western Ontario and McMaster Osteoarthritis Index score
Time frame: 12 weeks post-randomization
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2016.
- Individual participant dataSharing planned: Undecided
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The Feasibility of a Virtual/Home-based OA Treatment Program in Older Adults With OA and Multimorbidity
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas Buford, PhD principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Resistance Exercise and KAATSU exercise in people with Knee Osteoarthritis, run by University of Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in isokinetic muscle strength (time frame: 6 weeks post-randomization, 12 weeks post-randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Aug 2016.