OsteoarthritisNCT01483131
Vascular Occlusion in Patients With Osteoarthritis
A study testing Exercise training and Resistance training with vascular occlusion in people with Osteoarthritis, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
Resistance exercise plus vascular occlusion may induce greater improvements in strength and muscle mass than resistance training alone. The investigators speculate this training strategy could be beneficial in patients with osteoarthritis. Read more about this study
- Who is it for?
- Ages 50 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- Exercise training and Resistance training with vascular occlusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteBrazil
- Study dates
- Nov 2011to Dec 2014
- 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 50 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Postmenopausal women
- BMI <39
- Knee Ostearthritis type II and III
- VAS (visual analogue scale) between 2 and 8
Who cannot join
- Hip osteoarthritis
- Use of NSAID
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
University of Sao Paulo -School of Medicine - Clinical Hospital
São Paulo, São Paulo, 05403 010
Rodrigo Ferraz, Msc, 55 11 8122 1203, ferraz@email.com
Hamilton Roschel, PhD
About this study
Official title: Effects of Strength Training Associated With Vascular Occlusion in Patients With Knee Osteoarthritis
Resistance exercise plus vascular occlusion may induce greater improvements in strength and muscle mass than resistance training alone. The investigators speculate this training strategy could be beneficial in patients with osteoarthritis.
- Conditions
- Osteoarthritis
- Being tested
- Exercise training, Resistance training with vascular occlusion
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise trainingOther
12 weeks of resistance training twice a week.
Resistance training with vascular occlusionOther
12 weeks of resistance training with vascular occlusion twice a week
| Study group | Role | What they receive |
|---|---|---|
| Low intensity resistance training | Experimental | Not described Receives: Other: Exercise training |
| High intensity resistance training | Experimental | Not described Receives: Other: Exercise training |
| Low intensity resistance training with vascular occlusion | Experimental | Not described Receives: Other: Resistance training with vascular occlusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
muscle strength
Measured: 12 weeks
Secondary outcomes (1)
Quality of Life
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2011 (estimated)
- Study startNov 2011
- Primary completionNov 2013
- Study completionDec 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe 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
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bruno Gualano, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01483131
- Sponsor's protocol ID
- vascular occlusion and OA
- Status last verified
- Feb 2014
- First submitted
- 29 Nov 2011
- Last updated
- 28 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Strength Training Associated With Vascular Occlusion in Patients With Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT01483131
- Acronym / sponsor ID
- vascular occlusion and OA
- Conditions
- Osteoarthritis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- Nov 2011
- Primary completion
- Nov 2013 (actual)
- Study completion
- Dec 2014 (estimated)
- First posted
- 1 Dec 2011 (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.
Resistance exercise plus vascular occlusion may induce greater improvements in strength and muscle mass than resistance training alone. The investigators speculate this training strategy could be beneficial in patients with osteoarthritis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Low intensity resistance training | Experimental | Other: Exercise training |
| High intensity resistance training | Experimental | Other: Exercise training |
| Low intensity resistance training with vascular occlusion | Experimental | Other: Resistance training with vascular occlusion |
Who may qualify
- Ages
- 50 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Postmenopausal women
- BMI <39
- Knee Ostearthritis type II and III
- VAS (visual analogue scale) between 2 and 8
Key exclusion criteria (2 listed)
- Hip osteoarthritis
- Use of NSAID
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 |
|---|---|---|
| Exercise training12 weeks of resistance training twice a week. | Other | High intensity resistance training, Low intensity resistance training |
| Resistance training with vascular occlusion12 weeks of resistance training with vascular occlusion twice a week | Other | Low intensity resistance training with vascular occlusion |
Primary outcome
muscle strength
Time frame: 12 weeks
1 secondary outcome
Quality of Life
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2014.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise training and Resistance training with vascular occlusion in people with Osteoarthritis, run by University of Sao Paulo at 1 site in Brazil.
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 4 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 28 Feb 2014. 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 Brazil. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rodrigo Ferraz, Msc (55 11 8122 1203, ferraz@email.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
muscle strength (time frame: 12 weeks). 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 28 Feb 2014.