NCT02600702

Brief Summary

The purpose of this study is to compare the exercise protocol called "Siriraj home base exercise program for OA knee" to usual care and physical modalities for conservative treatment in patients with 1st OA knee.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
135

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2014

Geographic Reach
1 country

1 active site

Status
completed

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

October 1, 2014

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

November 6, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 9, 2015

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2016

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

December 2, 2016

Status Verified

December 1, 2016

Enrollment Period

1.3 years

First QC Date

November 6, 2015

Last Update Submit

December 1, 2016

Conditions

Osteoarthritis, Knee

Keywords

Home base exercise

Outcome Measures

Primary Outcomes (1)

  • WOMAC score

    3 months

Secondary Outcomes (1)

  • 6 mins walk test

    3 months

Study Arms (3)

usual care

NO INTERVENTION

quadricep exercise

Siriraj home base exercise

EXPERIMENTAL

Knee exercise protocol for 12 position for 3 months with low-impact aerobic exercise

Other: Siriraj knee exercise

Modalities and exercise

ACTIVE COMPARATOR

Physical modalities for 6 weeks and Knee exercise protocol for 12 position for 3 months with low-impact aerobic exercise

Other: Siriraj knee exerciseOther: Physical modalities

Interventions

Siriraj knee exerciseOTHER

Siriraj knee exercise, 12 position of exercise protocol

Modalities and exerciseSiriraj home base exercise
Physical modalitiesOTHER
Modalities and exercise

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • st osteoarthritis of the knee Age \>/= 50 yrs

You may not qualify if:

  • Previous knee surgery for OA knee treatment
  • Has plan or schedule for knee surgery
  • Severe degree of OA knee.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Siriraj hospital

Bangkok, Thailand

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Physical Therapy Modalities

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

TherapeuticsRehabilitation

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 6, 2015

First Posted

November 9, 2015

Study Start

October 1, 2014

Primary Completion

February 1, 2016

Study Completion

June 1, 2016

Last Updated

December 2, 2016

Record last verified: 2016-12

Locations

TH(1)