Accommodating Variable-Resistance Training in Patients With Juvenile Idiopathic Arthritis

Juvenile Idiopathic Arthritis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05805969
• Other study ID #: RHPT/0021/0036
• Status: Completed
• Phase: N/A
• Start date: November 28, 2021
• Est. completion date: January 19, 2023

Study information

• Verified date: March 2023
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 1. Muscle architecture: the fascicle length, pennation angle, and thickness of the vastus lateralis muscle were assessed using a standard high-resolution ultrasound imaging system. 2. Muscle strength: The peak concentric torque of the right and left knee extensors was measured through an isokinetic dynamometer. 3. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: January 19, 2023
• Est. primary completion date: January 19, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Juvenile
• Juvenile Idiopathic Arthritis

Intervention

Other:
• Accommodating variable-resistance training
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.
• Standard physical therapy
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.

Locations

Country	Name	City	State
Saudi Arabia	Ragab K. Elnaggar	Al Kharj	Riyadh

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Saudi Arabia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fascicle length	The linear distance (mm) between the insertion into the deep and superficial aponeurosis.	2 months
Primary	Pennation angle	The angle (in degrees) between the fascicle and the deep aponeurosis.	2 months
Primary	Muscle thickness	The perpendicular distance (mm) between the deep and superficial aponeurosis.	2 months
Primary	Muscle strength	Indicated by the peak concentric torque of the knee extensors (Nm). It was measured using an Isokinetic Dynamometer.	2 months
Secondary	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.	2 months
Secondary	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.	2 months
Secondary	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.	2 months