NCT05304832

Brief Summary

This study was designed to assess the effect of a 12-week aqua-plyometric (AquaPlyo) training on muscle strength, bone health, and physical ability in children with juvenile idiopathic arthritis (JIA). Forty-eight patients with JIA were randomly allocated to the AquaPlyo group (n = 24, received an aquatic-based plyometric training program, twice/week, over 12 weeks) or the control group (n = 24, received standard exercise program). Both groups were assessed for muscle strength, bone health, and physical ability pre and post-treatment.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2020

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

December 6, 2020

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 22, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 31, 2022

Completed
Last Updated

December 28, 2022

Status Verified

December 1, 2022

Enrollment Period

1.2 years

First QC Date

March 22, 2022

Last Update Submit

December 24, 2022

Conditions

Outcome Measures

Primary Outcomes (4)

  • Muscle strength

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

    2 months

  • Areal bone mineral density

    The amount of bone mineral divided by the bone scanned area (gm/cm2). It was assessed through DEXA scanining.

    2 months

  • Volumetric bone mineral density

    The mineral mass per unit volume of bone (gm/cm3). It was assessed through DEXA scanining.

    2 months

  • Bone mineral content

    It is the amount of bone mineral in bone tissue (g/cm). It was calculated by summing the bone mineral density values over the projected area.

    2 months

Secondary Outcomes (1)

  • Physical ability

    2 months

Study Arms (2)

AquaPlyo group

EXPERIMENTAL

Participants in this group received the AquaPlyo training program

Other: Aqua-Plyometric Exercise

Control group

ACTIVE COMPARATOR

Participants in this group received the standard exercise program.

Other: Standard physical therapy

Interventions

The aqua-plyometric training was conducted for 45 minutes, twice weekly, for 12 successive weeks. The training was geared toward the lower body and was conducted under 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.

AquaPlyo group

The program encompassed the standard exercises for patients with JIA (aerobic, weight-bearing, proprioceptive, flexibility, and strengthening exercises). The training was conducted for 40 minutes, two times a week for 12 successive weeks.

Control group

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

Related Publications (1)

  • Elnaggar RK, Elfakharany MS. Aqua-Plyometric Exercises-Induced Changes in Muscle Strength, Bone Mineral Properties, and Physical Fitness in Patients With Juvenile Idiopathic Arthritis: A 12-Week, Randomized Controlled Trial. Pediatr Exerc Sci. 2022 Dec 19;35(4):198-205. doi: 10.1123/pes.2022-0044. Print 2023 Nov 1.

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
Associate Professor

Study Record Dates

First Submitted

March 22, 2022

First Posted

March 31, 2022

Study Start

December 6, 2020

Primary Completion

January 30, 2022

Study Completion

January 30, 2022

Last Updated

December 28, 2022

Record last verified: 2022-12

Data Sharing

IPD Sharing
Will not share

Locations