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Accommodating Variable-Resistance Training in Patients With Juvenile Idiopathic Arthritis

Primary Purpose

Juvenile Idiopathic Arthritis

Status
Completed
Phase
Not Applicable
Locations
Saudi Arabia
Study Type
Interventional
Intervention
Accommodating variable-resistance training
Standard physical therapy
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Juvenile Idiopathic Arthritis

Eligibility Criteria

12 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Ragab K. Elnaggar

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Accommodating variable-resistance training

Standard Physical Therapy

Arm Description

Participants in this group received the Accommodating variable-resistance program in addition to the standard physical therapy.

Participants in this group received the standard exercise program.

Outcomes

Primary Outcome Measures

Fascicle length
The linear distance (mm) between the insertion into the deep and superficial aponeurosis.
Pennation angle
The angle (in degrees) between the fascicle and the deep aponeurosis.
Muscle thickness
The perpendicular distance (mm) between the deep and superficial aponeurosis.
Muscle strength
Indicated by the peak concentric torque of the knee extensors (Nm). It was measured using an Isokinetic Dynamometer.

Secondary Outcome Measures

Six-minute walk test
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.
Timed up and down stairs test
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.
4x10 meter Shuttle Run test
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.

Full Information

First Posted
March 28, 2023
Last Updated
March 28, 2023
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT05805969
Brief Title
Accommodating Variable-Resistance Training in Patients With Juvenile Idiopathic Arthritis
Official Title
Efficacy of Accommodating Variable-Resistance Training on Muscle Architecture, Strength, and Functional Performance in Patients With Juvenile Idiopathic Arthritis: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
November 28, 2021 (Actual)
Primary Completion Date
January 19, 2023 (Actual)
Study Completion Date
January 19, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This study was designed to investigate the effect of six weeks of accommodating variable-resistance training on muscle architecture, muscle strength, and functional performance in patients with juvenile idiopathic arthritis. Fifty-eight children with juvenile idiopathic arthritis were randomly allocated to the experimental group (n = 29, received the accommodating variable-resistance training) or the Control group (n = 29, received usual physical rehabilitation alone). Both groups were assessed for muscle architecture, muscle strength, and functional performance before and after 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.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
A prospective, dual-arm, randomized controlled trial
Masking
Outcomes Assessor
Masking Description
This was a single-blind protocol. The researcher who collected the data was blind to the allocation of treatment
Allocation
Randomized
Enrollment
58 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Accommodating variable-resistance training
Arm Type
Experimental
Arm Description
Participants in this group received the Accommodating variable-resistance program in addition to the standard physical therapy.
Arm Title
Standard Physical Therapy
Arm Type
Active Comparator
Arm Description
Participants in this group received the standard exercise program.
Intervention Type
Other
Intervention Name(s)
Accommodating variable-resistance training
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Standard physical therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Fascicle length
Description
The linear distance (mm) between the insertion into the deep and superficial aponeurosis.
Time Frame
2 months
Title
Pennation angle
Description
The angle (in degrees) between the fascicle and the deep aponeurosis.
Time Frame
2 months
Title
Muscle thickness
Description
The perpendicular distance (mm) between the deep and superficial aponeurosis.
Time Frame
2 months
Title
Muscle strength
Description
Indicated by the peak concentric torque of the knee extensors (Nm). It was measured using an Isokinetic Dynamometer.
Time Frame
2 months
Secondary Outcome Measure Information:
Title
Six-minute walk test
Description
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.
Time Frame
2 months
Title
Timed up and down stairs test
Description
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.
Time Frame
2 months
Title
4x10 meter Shuttle Run test
Description
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.
Time Frame
2 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ragab K. Elnaggar, PhD
Organizational Affiliation
Prince Sattam Bin Abdulaziz University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ragab K. Elnaggar
City
Al Kharj
State/Province
Riyadh
Country
Saudi Arabia

12. IPD Sharing Statement

Plan to Share IPD
No

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Accommodating Variable-Resistance Training in Patients With Juvenile Idiopathic Arthritis

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