Vascular Occlusion in Patients With Osteoarthritis | NCT01483131

Studies
Vascular Occlusion in Patients With Osteoarthritis

NCT01483131

Sponsor

University of Sao Paulo

Status

Unknown status

Last Update Posted

Feb 28, 2014Estimated

Enrollment

45Estimated

Phase

Not Applicable

Conditions

Osteoarthritis

Interventions

Exercise training
Resistance training with vascular occlusion

Countries

Brazil

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2014

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2011

Primary Completion Date

Nov 2013Actual

Completion Date

Dec 2014Estimated

First Submitted Date

Nov 29, 2011

First Submission Date that Met QC Criteria

Nov 30, 2011

First Posted Date

Dec 1, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 27, 2014

Last Update Posted Date

Feb 28, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

45Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Exercise training	Other	12 weeks of resistance training twice a week.	High intensity resistance training Low intensity resistance training

Measure	Description	Time Frame
muscle strength		12 weeks

Measure	Description	Time Frame
Quality of Life		12 weeks

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Postmenopausal women
BMI <39
Knee Ostearthritis type II and III
VAS (visual analogue scale) between 2 and 8

Exclusion Criteria:

Hip osteoarthritis
Use of NSAID

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

50 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Rodrigo Ferraz, Msc	Contact	55 11 8122 1203		ferraz@email.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Sao Paulo -School of Medicine - Clinical Hospital	Recruiting	São Paulo	São Paulo	05403 010	Brazil

Condition Browse Module

MeSH Terms

ID	Term
D010003	Osteoarthritis

Ancestor Terms

ID	Term
D001168	Arthritis
D007592	Joint Diseases
D009140	Musculoskeletal Diseases
D012216	Rheumatic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D015444	Exercise
D055070	Resistance Training

Ancestor Terms

ID	Term
D009043	Motor Activity
D009068	Movement
D009142	Musculoskeletal Physiological Phenomena
D055687	Musculoskeletal and Neural Physiological Phenomena

Browse Leaves

Not provided

Browse Branches

Not provided