Juvenile Idiopathic ArthritisNCT05304832
The Role of Aquatic-Based Plyometric Exercises for Patients With Juvenile Idiopathic Arthritis
A study testing Aqua-Plyometric Exercise and Standard physical therapy in people with Juvenile Idiopathic Arthritis, run by Cairo University at 1 site in Saudi Arabia.
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). Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Juvenile Idiopathic Arthritis
- What is being tested?
- Aqua-Plyometric Exercise and Standard physical therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 6 Dec 2020to 30 Jan 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Juvenile Idiopathic Arthritis
- Being tested
- Aqua-Plyometric Exercise, Standard physical therapy
- Medical subject headings
- Arthritis, Juvenile
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aqua-Plyometric ExerciseOther
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 therapyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| AquaPlyo group | Experimental | Participants in this group received the AquaPlyo training program Receives: Other: Aqua-Plyometric Exercise |
| Control group | Active comparator | Participants in this group received the standard exercise program. Receives: Other: Standard physical therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle strength
Indicated by the peak concentric torque of the quadriceps muscle (Nm). It was measured using an Isokinetic Dynamometer.
Measured: 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.
Measured: 2 months
Volumetric bone mineral density
The mineral mass per unit volume of bone (gm/cm3). It was assessed through DEXA scanining.
Measured: 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.
Measured: 2 months
Secondary outcomes (1)
Physical ability
The maximum distance (m) that participants were able to cover during the 6-minute walk test.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2022
- Study start6 Dec 2020
- Primary completion30 Jan 2022
- Study completion30 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Juvenile Idiopathic ArthritisStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A prospective, dual-arm, randomized controlled trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ragab Kamal Elnaggar, Cairo University
- Investigators
- Ragab K Elnaggar, PhD, Principal investigator, Prince Sattam Bin Abdulaziz University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05304832
- Sponsor's protocol ID
- RHPT/0020/0045
- Status last verified
- Dec 2022
- First submitted
- 22 Mar 2022
- Last updated
- 28 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 36535274
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05304832
- Acronym / sponsor ID
- RHPT/0020/0045
- Conditions
- Juvenile Idiopathic Arthritis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 6 Dec 2020 (actual)
- Primary completion
- 30 Jan 2022 (actual)
- Study completion
- 30 Jan 2022 (actual)
- First posted
- 31 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- A prospective, dual-arm, randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| AquaPlyo group | Experimental | Other: Aqua-Plyometric ExerciseParticipants in this group received the AquaPlyo training program |
| Control group | Active comparator | Other: Standard physical therapyParticipants in this group received the standard exercise program. |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- Fixed deformities
- History of joint surgery
- Ankylosing or fractures
- Bone destruction (erosive changes of the knee joint)
- Cardiopulmonary comorbidities
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aqua-Plyometric ExerciseThe 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. | Other | AquaPlyo group |
| Standard physical therapyThe 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. | Other | Control group |
Primary outcome
Muscle strength
Time frame: 2 months
Indicated by the peak concentric torque of the quadriceps muscle (Nm). It was measured using an Isokinetic Dynamometer.
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.
Volumetric bone mineral density
Time frame: 2 months
The mineral mass per unit volume of bone (gm/cm3). It was assessed through DEXA scanining.
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.
1 secondary outcome
Physical ability
Time frame: 2 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Dec 2022.
- Derived from this study: PubMed 36535274Elnaggar 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ragab K Elnaggar, PhD principal investigator
Prince Sattam Bin Abdulaziz University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aqua-Plyometric Exercise and Standard physical therapy in people with Juvenile Idiopathic Arthritis, run by Cairo University at 1 site in Saudi Arabia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Muscle strength (time frame: 2 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05304832, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Dec 2022.