The Role of Aquatic-Based Plyometric Exercises for Patients With Juvenile Idiopathic Arthritis
Primary Purpose
Juvenile Idiopathic Arthritis
Status
Completed
Phase
Not Applicable
Locations
Saudi Arabia
Study Type
Interventional
Intervention
Aqua-Plyometric Exercise
Standard physical therapy
Sponsored by
About this trial
This is an interventional treatment trial for Juvenile Idiopathic Arthritis
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.
Sites / Locations
- Ragab K. Elnaggar
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
AquaPlyo group
Control group
Arm Description
Participants in this group received the AquaPlyo training program
Participants in this group received the standard exercise program.
Outcomes
Primary Outcome Measures
Muscle strength
Indicated by the peak concentric torque of the quadriceps muscle (Nm). It was measured using an Isokinetic Dynamometer.
Areal bone mineral density
The amount of bone mineral divided by the bone scanned area (gm/cm2). It was assessed through DEXA scanining.
Volumetric bone mineral density
The mineral mass per unit volume of bone (gm/cm3). It was assessed through DEXA scanining.
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.
Secondary Outcome Measures
Physical ability
The maximum distance (m) that participants were able to cover during the 6-minute walk test.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05304832
Brief Title
The Role of Aquatic-Based Plyometric Exercises for Patients With Juvenile Idiopathic Arthritis
Official Title
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 Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
December 6, 2020 (Actual)
Primary Completion Date
January 30, 2022 (Actual)
Study Completion Date
January 30, 2022 (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 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.
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.
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
48 (Actual)
8. Arms, Groups, and Interventions
Arm Title
AquaPlyo group
Arm Type
Experimental
Arm Description
Participants in this group received the AquaPlyo training program
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
Participants in this group received the standard exercise program.
Intervention Type
Other
Intervention Name(s)
Aqua-Plyometric Exercise
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Standard physical therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Muscle strength
Description
Indicated by the peak concentric torque of the quadriceps muscle (Nm). It was measured using an Isokinetic Dynamometer.
Time Frame
2 months
Title
Areal bone mineral density
Description
The amount of bone mineral divided by the bone scanned area (gm/cm2). It was assessed through DEXA scanining.
Time Frame
2 months
Title
Volumetric bone mineral density
Description
The mineral mass per unit volume of bone (gm/cm3). It was assessed through DEXA scanining.
Time Frame
2 months
Title
Bone mineral content
Description
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.
Time Frame
2 months
Secondary Outcome Measure Information:
Title
Physical ability
Description
The maximum distance (m) that participants were able to cover during the 6-minute walk test.
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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The Role of Aquatic-Based Plyometric Exercises for Patients With Juvenile Idiopathic Arthritis
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