NCT04834050

Brief Summary

Quadriceps femoris (QF) atrophy is seen in rheumatoid arthritis and knee osteoarthritis (OA) patients. Exercise therapy is mile stone in knee OA patients also it can help thicken QF muscle of RA patients. We primarily aimed to demonstrate the influence of 4 weeks of knee isometric home-based training on QF muscle parts thickness and pennation angle measurements of RA patients with ultrasonography (USG). This study included 12 patients with RA, 12 patients with knee OA as positive control group and 13 volunteers as healthy control group. All participants were given 4 weeks of quadriceps-hamstring isometric home-based training. At baseline and at the end of the program, WOMAC and Lequesne algofunctional index scores of knee OA patients and DAS28-CRP scores of RA patients were recorded. Dominant knee thickness and pennation angle measurements of QF muscle parts were evaluated by ultrasonography.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
37

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2018

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2018

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 12, 2019

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 20, 2020

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

March 31, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 6, 2021

Completed
Last Updated

April 6, 2021

Status Verified

April 1, 2021

Enrollment Period

8 months

First QC Date

March 31, 2021

Last Update Submit

April 5, 2021

Conditions

Arthritis, RheumatoidKnee OsteoarthritisQuadriceps Muscle AtrophyUltrasonographyExercise

Outcome Measures

Primary Outcomes (2)

  • Change of quadriceps femoris parts thickness measures

    Dominant knee vastus lateralis, medialis, intermedius and rectus femoris thicknesses of 3 groups were calculated at baseline and at the end of intervention.

    At baseline and after 4 weeks of intervention

  • Change of quadriceps femoris parts pennation angles

    Pennation angles of vastus lateralis, medialis and intermedius were calculated at baseline and at the end of exercise program.

    At baseline and after 4 weeks of intervention

Secondary Outcomes (3)

  • Change of The Western Ontario and McMaster Universities Arthritis Index (WOMAC) score of knee OA

    At baseline and after 4 weeks of intervention

  • Change of Disease activity score 28-C reactive protein (DAS28-CRP)

    At baseline and after 4 weeks of intervention

  • Change of Lequesne scores of knee OA patients

    At baseline and after 4 weeks of intervention

Study Arms (3)

Rheumatoid arthritis patients

EXPERIMENTAL
Procedure: Quadriceps femoris isometric home-based exercise

Knee Osteoarthritis patients

EXPERIMENTAL
Procedure: Quadriceps femoris isometric home-based exercise

Healthy patients

EXPERIMENTAL
Procedure: Quadriceps femoris isometric home-based exercise

Interventions

Quadriceps femoris isometric home-based exercisePROCEDURE

All 3 groups of participants were given 4-week (5 days/week) quadriceps-hamstring isometric home-based exercise training for their both knees. Exercises were performed (with maximal effort for 10 seconds) at a rate of 20 repetitions per day. Training was performed at outpatient clinic for 30 minutes.

Healthy patientsKnee Osteoarthritis patientsRheumatoid arthritis patients

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Volunteers who did not have any knee pain, no clinical degenerative or inflammatory signs were included in the healthy control group.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gazi University Faculty of Medicine

Ankara, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Arthritis, RheumatoidOsteoarthritis, KneeMotor Activity

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System DiseasesOsteoarthritisBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR INVESTIGATOR
PI Title
OB

Study Record Dates

First Submitted

March 31, 2021

First Posted

April 6, 2021

Study Start

October 1, 2018

Primary Completion

June 12, 2019

Study Completion

February 20, 2020

Last Updated

April 6, 2021

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)