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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05304832
Other study ID # RHPT/0020/0045
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 6, 2020
Est. completion date January 30, 2022

Study information

Verified date December 2022
Source Cairo University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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 1. Muscle strength: The peak concentric torque of the right and left quadriceps muscle was measured through an Isokinetic Dynamometer. 2. 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. 3. 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.


Recruitment information / eligibility

Status Completed
Enrollment 48
Est. completion date January 30, 2022
Est. primary completion date January 30, 2022
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.

Study Design


Intervention

Other:
Aqua-Plyometric Exercise
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.
Standard physical therapy
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.

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 Muscle strength Indicated by the peak concentric torque of the quadriceps muscle (Nm). It was measured using an Isokinetic Dynamometer. 2 months
Primary 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
Primary Volumetric bone mineral density The mineral mass per unit volume of bone (gm/cm3). It was assessed through DEXA scanining. 2 months
Primary 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 Physical ability The maximum distance (m) that participants were able to cover during the 6-minute walk test. 2 months
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