Fitness Training for Juvenile Arthritis

(FIT Teens 2 Trial)

Overseen By Megan Pfeiffer

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Children's Hospital Medical Center, Cincinnati

Disqualifiers: Major psychiatric diagnoses, Developmental delay, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 16

Duration: 8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate the effectiveness of a new program called FIT Teens for young people with specific joint conditions. FIT Teens combines pain and stress management skills, such as deep breathing, with exercises to build strength and improve balance. The trial seeks participants diagnosed with pediatric rheumatic diseases or joint hypermobility for at least three months who continue to experience muscle or joint pain and/or fatigue. As an unphased trial, this study provides a unique opportunity for participants to contribute to innovative research that could enhance management strategies for joint conditions.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the FIT Teens program is safe for teens with pediatric rheumatic diseases?

Research has shown that exercise programs like FIT Teens are safe for kids with juvenile arthritis. Studies have found that these exercises do not worsen the condition and might even improve it. FIT Teens combines exercises to strengthen muscles and improve balance with lessons on managing pain. Previous trials of similar programs showed good results, with participants feeling better and not experiencing major side effects. Overall, current evidence suggests the treatment is well-tolerated. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard treatments for juvenile arthritis, which often include medication and physical therapy, FIT Teens combines cognitive behavioral therapy (CBT) with specialized neuromuscular exercise. This dual approach not only targets the physical symptoms by improving core strength, gait, and balance but also equips teens with pain coping skills like breathing, relaxation, and distraction techniques. Researchers are excited because this integrated method could offer a holistic way to manage both the mental and physical challenges of juvenile arthritis, potentially reducing reliance on medications.

What evidence suggests that the FIT Teens program is effective for juvenile arthritis?

The FIT Teens program, provided to participants in this trial, combines cognitive behavioral therapy (CBT) with specific exercises. Studies have shown that this program can aid young people with conditions like juvenile arthritis. Previous participants experienced better pain control and improved movement. Research indicates that exercise therapy is safe and may enhance the health of children with juvenile arthritis without worsening their condition. Additionally, the FIT Teens program successfully reduced disability and pain in similar conditions like juvenile fibromyalgia. These findings suggest that FIT Teens could effectively manage symptoms in children with rheumatic conditions. ^{3 5 6 7 8}

Who Is on the Research Team?

Susmita Kashikar-Zuck, PhD

Principal Investigator

Children's Hospital Medical Center, Cincinnati

Are You a Good Fit for This Trial?

This trial is for young people with pediatric rheumatic diseases like Juvenile Idiopathic Arthritis, Dermatomyositis, or Lupus. It's also open to those with joint issues such as instability or hypermobility. Participants should be interested in a program combining mental and physical exercises.

Inclusion Criteria

I have at least moderate disability.

My initial diagnosis was made over 3 months ago.

I have been diagnosed with a pediatric rheumatic disease or joint hypermobility.

Exclusion Criteria

Untreated major psychiatric diagnoses (e.g., major depression, bipolar disorder, psychoses) or documented developmental delay

Any other medical condition determined by their physician to be a contraindication for exercise

Childhood Myositis Assessment Scale (CMAS) ≤ 30

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo a combined cognitive behavioral therapy and neuromuscular exercise training program

8 weeks

16 sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 years

What Are the Treatments Tested in This Trial?

Interventions

• FIT Teens

Trial Overview The study is testing the FIT Teens program, which blends cognitive behavioral therapy (a type of talk therapy) with neuromuscular exercise training designed to help manage symptoms and improve quality of life for these patients.

How Is the Trial Designed?

Group I: FIT Teens Experimental Treatment 1 Intervention

Fitness Integrative Training for Teens (FIT Teens) is a combined coping skills training and physical exercise program. Pain coping skills training, also called cognitive behavioral therapy (CBT) teaches a number of behavioral skills (e.g. breathing, relaxation, activity pacing, distraction, and calming statements). Participants also receive a specialized type of neuromuscular exercise training which focuses on core strength, gait and balance.

Who Is Running the Clinical Trial?

Children's Hospital Medical Center, Cincinnati

Lead Sponsor

Trials

844

Recruited

6,566,000+

Published Research Related to This Trial

Youth resistance training, when appropriately prescribed and supervised, can provide significant health and fitness benefits for children and adolescents, similar to those seen in adults.

The National Strength and Conditioning Association (NSCA) emphasizes the importance of safe and effective resistance training practices to enhance health, fitness, and sports performance in young populations, based on a comprehensive review of scientific evidence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Youth resistance training: updated position statement paper from the national strength and conditioning association. Faigenbaum, AD., Kraemer, WJ., Blimkie, CJ., et al.[2022]

An Internet-based intervention significantly improved physical activity levels and maximum endurance time in children with juvenile idiopathic arthritis (JIA), particularly in those who were initially less active.

The program was found to be safe, feasible, and had good adherence among participants, indicating it could be a practical approach to enhance physical activity in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Promoting physical activity in children with juvenile idiopathic arthritis through an internet-based program: results of a pilot randomized controlled trial. Lelieveld, OT., Armbrust, W., Geertzen, JH., et al.[2013]

A systematic review of 10 studies involving children and adolescents with juvenile idiopathic arthritis (JIA) found that exercise interventions, including various types like aquatic and aerobic exercises, significantly improved pediatric activity capacity and quality of life outcomes.

Exercise therapy was well tolerated by participants, but the overall quality of evidence was moderate, indicating a need for more high-quality research to establish specific recommendations for clinical practice in managing JIA.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise Therapy in Juvenile Idiopathic Arthritis: A Systematic Review and Meta-Analysis. Kuntze, G., Nesbitt, C., Whittaker, JL., et al.[2018]

A 12-week functional strength training (FST) program significantly improved movement quality and various fitness performance measures in 144 untrained girls aged 12-13 compared to traditional strength training (TST).

While both training methods increased muscular strength, the FST group showed greater enhancements in deep squat, trunk stability, flexibility, and power, suggesting that FST may be more effective for health promotion and injury prevention in this age group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Functional Strength Training Program on Movement Quality and Fitness Performance Among Girls Aged 12-13 Years. Liao, T., Li, L., Wang, YT.[2019]

Physical fitness programs for adolescents should focus on key components like body composition, aerobic power, and strength to promote overall health.

There is a growing concern about sedentary lifestyles among young people, especially those with chronic illnesses or disabilities, highlighting the need for inclusive physical education initiatives.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adolescent Fitness. Meredith, CN., Frontera, WR.[2019]

The submaximal treadmill test demonstrated acceptable validity at the group level for estimating peak oxygen uptake (VO2peak) in patients with juvenile idiopathic arthritis (JIA), but it was not reliable for individual assessments due to large measurement errors.

The test showed good test-retest and inter-rater reliability, indicating it can be consistently used in a controlled setting, but its variability limits its effectiveness in daily clinical practice for individual patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Measurement properties and performance of an eight-minute submaximal treadmill test in patients with juvenile idiopathic arthritis: a controlled study. Risum, K., Edvardsen, E., Selvaag, AM., et al.[2023]

The study demonstrated that using wearable activity trackers is a feasible intervention for adolescents with juvenile idiopathic arthritis (JIA), as all 28 participants successfully used the device and completed the study measurements.

Participants logged activity for 72% of the intervention period, indicating good adherence, but further research is needed to assess the actual impact of the trackers on increasing physical activity levels in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A wearable activity tracker intervention for promoting physical activity in adolescents with juvenile idiopathic arthritis: a pilot study. Heale, LD., Dover, S., Goh, YI., et al.[2018]

The CrossFit Teens™ resistance training program significantly improved health-related fitness in adolescents, with notable reductions in waist circumference and BMI, as well as enhancements in flexibility and cardiorespiratory fitness over an 8-week period involving 96 students.

The program was found to be feasible, with a high retention rate of 82.3% and participant satisfaction scores averaging between 4.2 to 4.6 out of 5, indicating strong acceptance among the adolescents involved.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving health-related fitness in adolescents: the CrossFit Teens™ randomised controlled trial. Eather, N., Morgan, PJ., Lubans, DR.[2022]

Regular resistance training for children and adolescents can enhance muscular strength, improve body composition, promote bone health, and reduce the risk of sports-related injuries.

Effective pediatric resistance training programs should be well-designed and supervised by qualified professionals to ensure they meet the unique physical and psychosocial needs of young athletes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pediatric resistance training: benefits, concerns, and program design considerations. Faigenbaum, AD., Myer, GD.[2022]

Exercise therapy is safe for children with arthritis and does not worsen their condition, making it a viable option for improving their health.

Engaging in exercise can enhance function, quality of life, and physical fitness in children with juvenile idiopathic arthritis, although more research is needed to determine the most effective exercise prescriptions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical activity, physical fitness, and exercise therapy in children with juvenile idiopathic arthritis. Houghton, K.[2013]

Exercise training (ET) for juvenile idiopathic arthritis (JIA) is supported by moderate-quality evidence, showing improvements in pain, functional capability, and quality of life for participants aged 4 to 21 years, based on a review of 9 studies involving 457 individuals.

No adverse effects were reported from ET, indicating it is a safe intervention, with recommended sessions lasting 30-50 minutes, 2-3 times per week over a duration of 12-24 weeks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Structured Exercise Training in Children and Adolescents With Juvenile Idiopathic Arthritis. Klepper, S., Mano Khong, TT., Klotz, R., et al.[2019]

A six-week home-based resistance training program for children with juvenile idiopathic arthritis (JIA) was found to be safe, with no increase in pain or adverse events reported during the study.

The program was feasible, with participants completing an average of 70.6% of the sessions, and it resulted in a significant increase in muscle thickness, indicating potential benefits for muscle strength and function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and feasibility of a home-based six week resistance training program in juvenile idiopathic arthritis. Van Oort, C., Tupper, SM., Rosenberg, AM., et al.[2021]

In a study involving 30 patients with juvenile idiopathic arthritis, both strengthening and proprioceptive-balance exercise programs significantly improved lower extremity function, but the proprioceptive-balance exercises were more effective overall.

The proprioceptive-balance exercises led to improvements in walking, stair climbing, and balance, highlighting their importance in managing musculoskeletal symptoms in these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of strengthening versus balance-proprioceptive exercises on lower extremity function in patients with juvenile idiopathic arthritis: a randomized, single-blind clinical trial. Baydogan, SN., Tarakci, E., Kasapcopur, O.[2022]

Citations

1. withpower.com withpower.com/trial/phase-juvenile-idiopathic-arthritis-jia-7-2024-79a0c

Fitness Training for Juvenile Arthritis (FIT Teens 2 Trial) Recent studies suggest that exercise therapy is safe for children with juvenile arthritis and does not worsen their condition. It may even improve their ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9707024/

FIT Teens RCT for juvenile fibromyalgia: Protocol adaptations ... The FIT Teens trial is a multi-site comparative effectiveness RCT that aims to establish whether a multi-component intervention (CBT + neuromuscular exercise ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT05114343?term=AREA%5BConditionSearch%5D(%22Arthritis,%20Juvenile%22)&rank=5

Effectiveness and Feasibility of a Home-based Exercise ... This study will aim to test the effectiveness and feasibility of a technology-supported home-based exercise program in adolescents with JIA.

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1551714421000574

Randomized clinical trial of Fibromyalgia Integrative ... This multi-site RCT is designed to evaluate whether the combined FIT Teens intervention will have significantly greater effects on disability and pain reduction ...

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/33618033/

Randomized clinical trial of Fibromyalgia Integrative Training ... This 3-arm multi-site RCT will examine the efficacy of the FIT Teens intervention in reducing functional disability (primary outcome) and pain intensity ( ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06556992

Fitness Integrative Training for Pediatric Rheumatology ... This study evaluates the feasibility of the Fitness Integrative Training program for Teens (FIT Teens 2), a combined cognitive behavioral therapy and ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8089039/

Randomized Clinical Trial of Fibromyalgia Integrative Training ... It is hypothesized that participants in the FIT Teens arm will show significantly greater reduction in functional disability at the primary end point (3-month ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S1526590018301445

Pilot Randomized Trial of Integrated Cognitive-Behavioral ... Results of this pilot trial of the Fibromyalgia Integrative Training for Teens (FIT Teens) program were promising. •. FIT Teens was more effective than ...