- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05805969
Accommodating Variable-Resistance Training in Patients With Juvenile Idiopathic Arthritis
Efficacy of Accommodating Variable-Resistance Training on Muscle Architecture, Strength, and Functional Performance in Patients With Juvenile Idiopathic Arthritis: A Randomized Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Fifty-eight patients with juvenile idiopathic arthritis participated in the study. They were recruited from King Khalid Hospital and two other referral hospitals, in Riyadh, Saudi Arabia. They were between 12 and 18 years old, had poly-articular onset and bilateral knee involvement, were on stable doses of medications, and were not engaging in regular exercise regimens. Patients were excluded if they had fixed deformities, a history of joint surgery, or whose radiological investigations revealed erosive changes of bone, ankylosing, or fractures.
Outcome measures
- Muscle architecture: the fascicle length, pennation angle, and thickness of the vastus lateralis muscle were assessed using a standard high-resolution ultrasound imaging system.
- Muscle strength: The peak concentric torque of the right and left knee extensors was measured through an isokinetic dynamometer.
- Functional capacity: Three tests were used; the 6-minute walk test, the timed up and down stairs test, and the 4x10 meter Shuttle Run test.
The experimental group received a 6-week accommodating variable-resistance training, two times a week for six consecutive weeks, in conformity with the National Strength and Conditioning Association guidelines and American Academy of Pediatrics safety standards. The training protocol included maximum voluntary concentric knee flexor/extensor actions through a motion range between 10 and 90 degrees. Three sets of five to 10 repetitions at angular speeds of 240, 180, and 120 degrees/second were performed. The training started with a warm-up for 10 minutes and ended with a cool-down for 5 minutes.
The control group received the standard exercise program, 45 minutes per session, two times a week for six consecutive weeks. The program consisted of flexibility exercise, strength training, weight-bearing, proprioceptive training, and free treadmill walking or cycle ergometry.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
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Riyadh
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Al Kharj, Riyadh, Saudi Arabia
- Ragab K. Elnaggar
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Confirmed diagnosis of JIA
- Polyarticular onset of JIA with bilateral involvement of the knee joint
- Age between 12 and 18 years
- Stable conditions (i.e., receive stable doses of medications in the past three months)
- Not participating in a regular exercise program in the past six months
Exclusion Criteria:
- Fixed deformities
- History of joint surgery
- Ankylosing or fractures
- Bone destruction (erosive changes of the knee joint)
- Cardiopulmonary comorbidities
- Recommendation against engaging in potentially explosive physical activities by the attending Rheumatologist.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Accommodating variable-resistance training
Participants in this group received the Accommodating variable-resistance program in addition to the standard physical therapy.
|
The training was conducted twice weekly for six successive weeks under the close supervision of a licensed pediatric physical therapist in accordance with the safety performance guidelines defined by the American Academy of Pediatrics and the US National Strength and Conditioning Association. The training protocol included maximum voluntary concentric knee flexor/extensor actions. Three sets of five to 10 repetitions of maximum-effort concentric action at angular speeds of 240, 180, and 120 degrees/second. The training started with a 10-minute warm-up exercise and ended up with a 5-minute cool-down exercise. |
|
Active Comparator: Standard Physical Therapy
Participants in this group received the standard exercise program.
|
The program encompassed the standard exercises for patients with juvenile idiopathic arthritis (aerobic, weight-bearing, proprioceptive, flexibility, and strengthening exercises).
The training was conducted for 45 minutes, two times a week for six successive weeks.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Fascicle length
Time Frame: 2 months
|
The linear distance (mm) between the insertion into the deep and superficial aponeurosis.
|
2 months
|
|
Pennation angle
Time Frame: 2 months
|
The angle (in degrees) between the fascicle and the deep aponeurosis.
|
2 months
|
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Muscle thickness
Time Frame: 2 months
|
The perpendicular distance (mm) between the deep and superficial aponeurosis.
|
2 months
|
|
Muscle strength
Time Frame: 2 months
|
Indicated by the peak concentric torque of the knee extensors (Nm).
It was measured using an Isokinetic Dynamometer.
|
2 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Six-minute walk test
Time Frame: 2 months
|
This test identified the maximum distance (m) that each patient was able to cover over six minutes on a straight flat 30-m walkway, without running or jogging.
Walking is regarded as more efficient in line with a longer distance coverage.
|
2 months
|
|
Timed up and down stairs test
Time Frame: 2 months
|
This test measured the time (seconds) that each patient took to climb up and down a 14-step stair flight (each 20 cm in height).
Better performance is indicated by a shorter time.
|
2 months
|
|
4x10 meter Shuttle Run test
Time Frame: 2 months
|
This test measured the time (seconds) that each patient took to run forth and back a 10-meter track.
Better performance is indicated by a shorter time.
|
2 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Ragab K. Elnaggar, PhD, Prince Sattam bin Abdulaziz University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RHPT/0021/0036
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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