- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05304832
The Role of Aquatic-Based Plyometric Exercises for Patients With Juvenile Idiopathic Arthritis
The Effectiveness of Aqua-plyometric Exercises for Muscle Strength, Bone Health, and Physical Ability in Patients With Juvenile Idiopathic Arthritis. A 12-week, Randomized Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Forty-eight patients with JIA were recruited from the pediatric rheumatology clinics of three large referral hospitals in Riyadh, Saudi Arabia. The study included patients who had a confirmed diagnosis of Polyarticular JIA (according to the criteria set forth by the International League of Associations for Rheumatology), aged 12-18 years, identified being stable cases, and did not participate in a regular exercise program (in the past six months). Patients who had fixed deformities, a history of joint surgery, or whose radiological investigations revealed erosive changes of bone, ankylosing, or fractures were excluded.
Outcome measures
- Muscle strength: The peak concentric torque of the right and left quadriceps muscle was measured through an Isokinetic Dynamometer.
- Bone health: Areal bone mineral density, volumetric bone density, and bone mineral content of the lumbar spine and neck of femur were measured through Dual-Energy X-ray Absorptiometry (DEXA) scanning.
- Physical ability: The physical performance was assessed using the 6-minute walk test.
The AquaPlyo group received a 12-week AquaPlyo training, 45 minutes per session, two times a week for 12 consecutive weeks, in conformity with the National Strength and Conditioning Association guidelines and American Academy of Pediatrics safety standards. The AquaPlyo program consisted of ten unilateral and bilateral lower limb plyometrics in the form of hopping/bounding/jumping activities conducted in a water medium. The AquaPlyo training included a warm-up for 10 minutes and a cool-down for 5 minutes. The control group received the standard exercise program, 45 minutes per session, two times a week for 12 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
Genders Eligible for Study
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: AquaPlyo group
Participants in this group received the AquaPlyo training program
|
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.
|
|
Active Comparator: Control group
Participants in this group received the standard exercise program.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Muscle strength
Time Frame: 2 months
|
Indicated by the peak concentric torque of the quadriceps muscle (Nm).
It was measured using an Isokinetic Dynamometer.
|
2 months
|
|
Areal bone mineral density
Time Frame: 2 months
|
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
Time Frame: 2 months
|
The mineral mass per unit volume of bone (gm/cm3).
It was assessed through DEXA scanining.
|
2 months
|
|
Bone mineral content
Time Frame: 2 months
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Physical ability
Time Frame: 2 months
|
The maximum distance (m) that participants were able to cover during the 6-minute walk test.
|
2 months
|
Collaborators and Investigators
Sponsor
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/0020/0045
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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