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Progressive Collective-exercise Program on the Knee Osteoarthritis

Primary Purpose

Knee Osteoarthritis

Status

Completed

Phase

Not Applicable

Locations

Brazil

Study Type

Interventional

Intervention

Collective group exercise program in patients with KOA

Orientation (without exercise)

About this trial

This is an interventional treatment trial for Knee Osteoarthritis

Eligibility Criteria

50 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

symptomatic and moderate to severe medical diagnostic of KOA.
Subjects with normal cognitive functions and no restriction to perform physical activities were recruited from the hospital's KOA database and eligible to participate if they had presented: Lequesne questionnaire criteria (5 - 13.5), knee pain score between 3 and 7 (on a 0 -10 Visual Analogue Scale), stable doses of non-steroidal anti-inflammatory drugs (NSAIDs) and no regular physical exercise or use of canes in the months prior to the study.

Exclusion Criteria:

Symptomatic heart disease; symptomatic disease of the lower limbs (other than KOA); symptomatic lung disease; severe systemic disease; severe psychiatric illness; regular physical exercise (three or more times per week for at least 3 months); drug injection in the knee in the previous 3 months; physiotherapy on the lower limbs in the previous 3 months and absence in two consecutive training sessions or three nonconsecutive sessions

Sites / Locations

Federal University of Rio Grande do Norte

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Collective group exercise program in patients with KOA

Control group (without exercise)

Arm Description

Collective exercises program for patients with osteoarthritis and orientation about this disease

Orientation about osteoarthritis disease but without any exercise program

Outcomes

Primary Outcome Measures

Pain

pain assessed by Visual Analogue Scale

Secondary Outcome Measures

quality of life

quality of life assessed by SF-36 questionnaire

Full Information

NCT ID

NCT01850862

First Posted

May 4, 2013

Last Updated

May 15, 2013

Sponsor

Universidade Federal do Rio Grande do Norte

1. Study Identification

Unique Protocol Identification Number

NCT01850862

Brief Title

Progressive Collective-exercise Program on the Knee Osteoarthritis

Study Type

Interventional

2. Study Status

Record Verification Date

May 2013

Overall Recruitment Status

Completed

Study Start Date

June 2011 (undefined)

Primary Completion Date

October 2011 (Actual)

Study Completion Date

November 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Universidade Federal do Rio Grande do Norte

4. Oversight

5. Study Description

Brief Summary

The investigators hypothesized that an eight-week collective group exercise program would improve pain, quality of life and functional capacity in patients with knee osteoarthritis (KOA) compared with those receiving no exercise intervention.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Knee Osteoarthritis

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

30 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Collective group exercise program in patients with KOA

Arm Type

Experimental

Arm Description

Collective exercises program for patients with osteoarthritis and orientation about this disease

Arm Title

Control group (without exercise)

Arm Type

Active Comparator

Arm Description

Orientation about osteoarthritis disease but without any exercise program

Intervention Type

Other

Intervention Name(s)

Collective group exercise program in patients with KOA

Intervention Type

Other

Intervention Name(s)

Orientation (without exercise)

Intervention Description

Orientation about osteoarthritis disease but without any exercise program

Primary Outcome Measure Information:

Title

Pain

Description

pain assessed by Visual Analogue Scale

Time Frame

Eight weeks

Secondary Outcome Measure Information:

Title

quality of life

Description

quality of life assessed by SF-36 questionnaire

Time Frame

Eight weeks

Other Pre-specified Outcome Measures:

Title

functional capacity

Description

functional capacity assessed by Lequesne questionnaire and functional tests.

Time Frame

Eight weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

50 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: symptomatic and moderate to severe medical diagnostic of KOA. Subjects with normal cognitive functions and no restriction to perform physical activities were recruited from the hospital's KOA database and eligible to participate if they had presented: Lequesne questionnaire criteria (5 - 13.5), knee pain score between 3 and 7 (on a 0 -10 Visual Analogue Scale), stable doses of non-steroidal anti-inflammatory drugs (NSAIDs) and no regular physical exercise or use of canes in the months prior to the study. Exclusion Criteria: Symptomatic heart disease; symptomatic disease of the lower limbs (other than KOA); symptomatic lung disease; severe systemic disease; severe psychiatric illness; regular physical exercise (three or more times per week for at least 3 months); drug injection in the knee in the previous 3 months; physiotherapy on the lower limbs in the previous 3 months and absence in two consecutive training sessions or three nonconsecutive sessions

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Wouber Hérickson de Brito Vieira, PhD

Organizational Affiliation

Universidade Federal do Rio Grande do Norte

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Bento João Abreu, PhD

Organizational Affiliation

Universidade Federal do Rio Grande do Norte

Official's Role

Principal Investigator

Facility Information:

Facility Name

Federal University of Rio Grande do Norte

City

Natal

State/Province

ZIP/Postal Code

59072-970

Country

Brazil

12. IPD Sharing Statement

Citations:

PubMed Identifier

26237073

Citation

da Silva FS, de Melo FE, do Amaral MM, Caldas VV, Pinheiro IL, Abreu BJ, Vieira WH. Efficacy of simple integrated group rehabilitation program for patients with knee osteoarthritis: Single-blind randomized controlled trial. J Rehabil Res Dev. 2015;52(3):309-22. doi: 10.1682/JRRD.2014.08.0199.

Results Reference

derived

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Progressive Collective-exercise Program on the Knee Osteoarthritis

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