NCT01483131

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2011

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2011

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

November 29, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 1, 2011

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2013

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

February 28, 2014

Status Verified

February 1, 2014

Enrollment Period

2 years

First QC Date

November 29, 2011

Last Update Submit

February 27, 2014

Conditions

Osteoarthritis

Outcome Measures

Primary Outcomes (1)

  • muscle strength

    12 weeks

Secondary Outcomes (1)

  • Quality of Life

    12 weeks

Study Arms (3)

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

Exercise trainingOTHER

12 weeks of resistance training twice a week.

High intensity resistance trainingLow intensity resistance training
Resistance training with vascular occlusionOTHER

12 weeks of resistance training with vascular occlusion twice a week

Low intensity resistance training with vascular occlusion

Eligibility Criteria

Age50 Years - 65 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Hip osteoarthritis
  • Use of NSAID

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Sao Paulo -School of Medicine - Clinical Hospital

São Paulo, São Paulo, 05403 010, Brazil

RECRUITING

MeSH Terms

Conditions

Osteoarthritis

Interventions

ExerciseResistance Training

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaExercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPhysical Conditioning, Human

Central Study Contacts

Rodrigo Ferraz, Msc

CONTACT

55 11 8122 1203ferraz@email.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 29, 2011

First Posted

December 1, 2011

Study Start

November 1, 2011

Primary Completion

November 1, 2013

Study Completion

December 1, 2014

Last Updated

February 28, 2014

Record last verified: 2014-02

Locations

BR(1)