NCT05805969

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
58

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2021

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

November 28, 2021

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 19, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 19, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 28, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

April 10, 2023

Completed
Last Updated

April 10, 2023

Status Verified

March 1, 2023

Enrollment Period

1.1 years

First QC Date

March 28, 2023

Last Update Submit

March 28, 2023

Conditions

Juvenile Idiopathic Arthritis

Outcome Measures

Primary Outcomes (4)

  • Fascicle length

    The linear distance (mm) between the insertion into the deep and superficial aponeurosis.

    2 months

  • Pennation angle

    The angle (in degrees) between the fascicle and the deep aponeurosis.

    2 months

  • Muscle thickness

    The perpendicular distance (mm) between the deep and superficial aponeurosis.

    2 months

  • Muscle strength

    Indicated by the peak concentric torque of the knee extensors (Nm). It was measured using an Isokinetic Dynamometer.

    2 months

Secondary Outcomes (3)

  • Six-minute walk test

    2 months

  • Timed up and down stairs test

    2 months

  • 4x10 meter Shuttle Run test

    2 months

Study Arms (2)

Accommodating variable-resistance training

EXPERIMENTAL

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

Other: Accommodating variable-resistance training

Standard Physical Therapy

ACTIVE COMPARATOR

Participants in this group received the standard exercise program.

Other: Standard physical therapy

Interventions

Accommodating variable-resistance trainingOTHER

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.

Accommodating variable-resistance training
Standard physical therapyOTHER

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.

Standard Physical Therapy

Eligibility Criteria

Age12 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ragab K. Elnaggar

Al Kharj, Riyadh Region, Saudi Arabia

Location

MeSH Terms

Conditions

Arthritis, Juvenile

Condition Hierarchy (Ancestors)

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

Study Officials

  • Ragab K. Elnaggar, PhD

    Prince Sattam Bin Abdulaziz University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
This was a single-blind protocol. The researcher who collected the data was blind to the allocation of treatment
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: A prospective, dual-arm, randomized controlled trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

March 28, 2023

First Posted

April 10, 2023

Study Start

November 28, 2021

Primary Completion

January 19, 2023

Study Completion

January 19, 2023

Last Updated

April 10, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations

SA(1)