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

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This study evaluates the feasibility of the Fitness Integrative Training program for Teens (FIT Teens 2), a combined cognitive behavioral therapy and neuromuscular exercise training program in patients with pediatric rheumatic diseases and/or joint hypermobility.

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.

Is exercise training safe for children with juvenile arthritis?

Recent studies suggest that exercise therapy is safe for children with juvenile arthritis and does not worsen their condition. It may even improve their function, quality of life, and physical fitness. ^{1 2 3 4 5}

How does the FIT Teens treatment for juvenile arthritis differ from other treatments?

FIT Teens is unique because it focuses on resistance training, which is a type of exercise that uses weights or resistance to build strength. This approach is different from traditional treatments for juvenile arthritis, which often focus on medication and physical therapy. Resistance training can improve muscular strength, flexibility, and overall fitness, which may help manage symptoms and improve quality of life for teens with arthritis. ^{6 7 8 9 10}

What data supports the effectiveness of the treatment FIT Teens for juvenile arthritis?

Research shows that exercise therapy can improve physical fitness, reduce pain, and enhance quality of life in children and adolescents with juvenile arthritis. Additionally, structured exercise programs and wearable activity trackers have been found to increase physical activity levels, which is beneficial for managing juvenile arthritis. ^{1 4 11 12 13}

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

My initial diagnosis was made over 3 months ago.

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

I am between 10 and 19 years old.

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

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

Citations

1. United States pubmed.ncbi.nlm.nih.gov

Exercise Therapy in Juvenile Idiopathic Arthritis: A Systematic Review and Meta-Analysis. [2018]

2. England pubmed.ncbi.nlm.nih.gov

A wearable activity tracker intervention for promoting physical activity in adolescents with juvenile idiopathic arthritis: a pilot study. [2018]

3. United States pubmed.ncbi.nlm.nih.gov

Effects of Structured Exercise Training in Children and Adolescents With Juvenile Idiopathic Arthritis. [2019]

4. United States 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. [2013]

5. United States 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. [2022]

6. England pubmed.ncbi.nlm.nih.gov

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

7. England pubmed.ncbi.nlm.nih.gov

Safety and feasibility of a home-based six week resistance training program in juvenile idiopathic arthritis. [2021]

8. England 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. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

Youth resistance training: updated position statement paper from the national strength and conditioning association. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

Effects of Functional Strength Training Program on Movement Quality and Fitness Performance Among Girls Aged 12-13 Years. [2019]

11. England pubmed.ncbi.nlm.nih.gov

Improving health-related fitness in adolescents: the CrossFit Teens™ randomised controlled trial. [2022]

12. United States pubmed.ncbi.nlm.nih.gov

Pediatric resistance training: benefits, concerns, and program design considerations. [2022]

13. United States pubmed.ncbi.nlm.nih.gov

Adolescent Fitness. [2019]