Juvenile Idiopathic ArthritisNCT05805969
Accommodating Variable-Resistance Training in Patients With Juvenile Idiopathic Arthritis
A study testing Accommodating variable-resistance training 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 investigate the effect of six weeks of accommodating variable-resistance training on muscle architecture, muscle strength, and functional performance in patients with juvenile idiopathic arthritis. 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?
- Accommodating variable-resistance training and Standard physical therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 28 Nov 2021to 19 Jan 2023
- 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: Efficacy of Accommodating Variable-Resistance Training on Muscle Architecture, Strength, and Functional Performance in Patients With Juvenile Idiopathic Arthritis: A Randomized Controlled Trial
This study was designed to investigate the effect of six weeks of accommodating variable-resistance training on muscle architecture, muscle strength, and functional performance in patients with juvenile idiopathic arthritis. Fifty-eight children with juvenile idiopathic arthritis were randomly allocated to the experimental group (n = 29, received the accommodating variable-resistance training) or the Control group (n = 29, received usual physical rehabilitation alone). Both groups were assessed for muscle architecture, muscle strength, and functional performance before and after treatment.
Read the detailed description
Fifty-eight patients with juvenile idiopathic arthritis participated in the study. They were recruited from King Khalid Hospital and two other referral hospitals, in Riyadh, Saudi Arabia. They were between 12 and 18 years old, had poly-articular onset and bilateral knee involvement, were on stable doses of medications, and were not engaging in regular exercise regimens. Patients were excluded if they had fixed deformities, a history of joint surgery, or whose radiological investigations revealed erosive changes of bone, ankylosing, or fractures.
Outcome measures
- Muscle architecture: the fascicle length, pennation angle, and thickness of the vastus lateralis muscle were assessed using a standard high-resolution ultrasound imaging system.
- Muscle strength: The peak concentric torque of the right and left knee extensors was measured through an isokinetic dynamometer.
- Functional capacity: Three tests were used; the 6-minute walk test, the timed up and down stairs test, and the 4x10 meter Shuttle Run test.
The experimental group received a 6-week accommodating variable-resistance training, two times a week for six consecutive weeks, in conformity with the National Strength and Conditioning Association guidelines and American Academy of Pediatrics safety standards. The training protocol included maximum voluntary concentric knee flexor/extensor actions through a motion range between 10 and 90 degrees. Three sets of five to 10 repetitions at angular speeds of 240, 180, and 120 degrees/second were performed. The training started with a warm-up for 10 minutes and ended with a cool-down for 5 minutes.
The control group received the standard exercise program, 45 minutes per session, two times a week for six 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
- Accommodating variable-resistance training, 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.
Accommodating variable-resistance trainingOther
The training was conducted twice weekly for six successive weeks under the 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.
The training protocol included maximum voluntary concentric knee flexor/extensor actions. Three sets of five to 10 repetitions of maximum-effort concentric action at angular speeds of 240, 180, and 120 degrees/second.
The training started with a 10-minute warm-up exercise and ended up with a 5-minute cool-down exercise.
Standard physical therapyOther
The program encompassed the standard exercises for patients with juvenile idiopathic arthritis (aerobic, weight-bearing, proprioceptive, flexibility, and strengthening exercises). The training was conducted for 45 minutes, two times a week for six successive weeks.
| Study group | Role | What they receive |
|---|---|---|
| Accommodating variable-resistance training | Experimental | Participants in this group received the Accommodating variable-resistance program in addition to the standard physical therapy. Receives: Other: Accommodating variable-resistance training |
| Standard Physical Therapy | 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.
Fascicle length
The linear distance (mm) between the insertion into the deep and superficial aponeurosis.
Measured: 2 months
Pennation angle
The angle (in degrees) between the fascicle and the deep aponeurosis.
Measured: 2 months
Muscle thickness
The perpendicular distance (mm) between the deep and superficial aponeurosis.
Measured: 2 months
Muscle strength
Indicated by the peak concentric torque of the knee extensors (Nm). It was measured using an Isokinetic Dynamometer.
Measured: 2 months
Secondary outcomes (3)
Six-minute walk test
This test identified the maximum distance (m) that each patient was able to cover over six minutes on a straight flat 30-m walkway, without running or jogging. Walking is regarded as more efficient in line with a longer distance coverage.
Measured: 2 months
Timed up and down stairs test
This test measured the time (seconds) that each patient took to climb up and down a 14-step stair flight (each 20 cm in height). Better performance is indicated by a shorter time.
Measured: 2 months
4x10 meter Shuttle Run test
This test measured the time (seconds) that each patient took to run forth and back a 10-meter track. Better performance is indicated by a shorter time.
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 posted10 Apr 2023
- Study start28 Nov 2021
- Primary completion19 Jan 2023
- Study completion19 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 58 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
- NCT05805969
- Sponsor's protocol ID
- RHPT/0021/0036
- Status last verified
- Mar 2023
- First submitted
- 28 Mar 2023
- Last updated
- 10 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Accommodating Variable-Resistance Training on Muscle Architecture, Strength, and Functional Performance in Patients With Juvenile Idiopathic Arthritis: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05805969
- Acronym / sponsor ID
- RHPT/0021/0036
- Conditions
- Juvenile Idiopathic Arthritis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 28 Nov 2021 (actual)
- Primary completion
- 19 Jan 2023 (actual)
- Study completion
- 19 Jan 2023 (actual)
- First posted
- 10 Apr 2023 (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 investigate the effect of six weeks of accommodating variable-resistance training on muscle architecture, muscle strength, and functional performance in patients with juvenile idiopathic arthritis. Fifty-eight children with juvenile idiopathic arthritis were randomly allocated to the experimental group (n = 29, received the accommodating variable-resistance training) or the Control group (n = 29, received usual physical rehabilitation alone). Both groups were assessed for muscle architecture, muscle strength, and functional performance before and after treatment.
Detailed description
Fifty-eight patients with juvenile idiopathic arthritis participated in the study. They were recruited from King Khalid Hospital and two other referral hospitals, in Riyadh, Saudi Arabia. They were between 12 and 18 years old, had poly-articular onset and bilateral knee involvement, were on stable doses of medications, and were not engaging in regular exercise regimens. Patients were excluded if they had fixed deformities, a history of joint surgery, or whose radiological investigations revealed erosive changes of bone, ankylosing, or fractures.
Outcome measures
- Muscle architecture: the fascicle length, pennation angle, and thickness of the vastus lateralis muscle were assessed using a standard high-resolution ultrasound imaging system.
- Muscle strength: The peak concentric torque of the right and left knee extensors was measured through an isokinetic dynamometer.
- Functional capacity: Three tests were used; the 6-minute walk test, the timed up and down stairs test, and the 4x10 meter Shuttle Run test.
The experimental group received a 6-week accommodating variable-resistance training, two times a week for six consecutive weeks, in conformity with the National Strength and Conditioning Association guidelines and American Academy of Pediatrics safety standards. The training protocol included maximum voluntary concentric knee flexor/extensor actions through a motion range between 10 and 90 degrees. Three sets of five to 10 repetitions at angular speeds of 240, 180, and 120 degrees/second were performed. The training started with a warm-up for 10 minutes and ended with a cool-down for 5 minutes.
The control group received the standard exercise program, 45 minutes per session, two times a week for six 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 |
|---|---|---|
| Accommodating variable-resistance training | Experimental | Other: Accommodating variable-resistance trainingParticipants in this group received the Accommodating variable-resistance program in addition to the standard physical therapy. |
| Standard Physical Therapy | 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 |
|---|---|---|
| Accommodating variable-resistance trainingThe training was conducted twice weekly for six successive weeks under the 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. The training protocol included maximum voluntary concentric knee flexor/extensor actions. Three sets of five to 10 repetitions of maximum-effort concentric action at angular speeds of 240, 180, and 120 degrees/second. The training started with a 10-minute warm-up exercise and ended up with a 5-minute cool-down exercise. | Other | Accommodating variable-resistance training |
| Standard physical therapyThe program encompassed the standard exercises for patients with juvenile idiopathic arthritis (aerobic, weight-bearing, proprioceptive, flexibility, and strengthening exercises). The training was conducted for 45 minutes, two times a week for six successive weeks. | Other | Standard Physical Therapy |
Primary outcome
Fascicle length
Time frame: 2 months
The linear distance (mm) between the insertion into the deep and superficial aponeurosis.
Pennation angle
Time frame: 2 months
The angle (in degrees) between the fascicle and the deep aponeurosis.
Muscle thickness
Time frame: 2 months
The perpendicular distance (mm) between the deep and superficial aponeurosis.
Muscle strength
Time frame: 2 months
Indicated by the peak concentric torque of the knee extensors (Nm). It was measured using an Isokinetic Dynamometer.
3 secondary outcomes
Six-minute walk test
Time frame: 2 months
Timed up and down stairs test
Time frame: 2 months
4x10 meter Shuttle Run test
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 10 Apr 2023.
- 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 Accommodating variable-resistance training 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 10 Apr 2023. 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?
Fascicle length (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?
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 10 Apr 2023.