Fibromyalgia Integrative Training for Adolescents With Juvenile Fibromyalgia

NCT03268421 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 389

Last updated 2025-02-14

Study results available
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Summary

This study evaluated whether Fibromyalgia Integrative Training program for Teens (FIT Teens), a combined cognitive behavioral therapy and neuromuscular exercise training program is more effective in reducing disability in adolescents with Juvenile Fibromyalgia compared to cognitive behavioral therapy (CBT) alone or a graded aerobic exercise (GAE) program alone. One third of participants received the FIT Teens training; one third received CBT training; and one third of participants received the GAE training.

Conditions

  • Fibromyalgia
  • Myofascial Pain Syndrome
  • Muscular Diseases
  • Musculoskeletal Disease
  • Rheumatic Diseases

Interventions

BEHAVIORAL

Fibromyalgia Integrative Training for Teens

This intervention will consist of 16 in-person group-based sessions held twice per week over 8 weeks. Sessions last 90 minutes and will be led jointly by a psychologist/therapist and exercise trainer using manualized protocols.

BEHAVIORAL

Cognitive Behavioral Therapy

This intervention will consist of 16 in-person group-based sessions held twice per week over 8 weeks. Sessions last 90 minutes and will be led jointly by a psychologist/therapist and exercise trainer using manualized protocols.

BEHAVIORAL

Graded Aerobic Exercise

This intervention will consist of 16 in-person group-based sessions held twice per week over 8 weeks. Sessions last 90 minutes and will be led jointly by a psychologist/therapist and exercise trainer using manualized protocols.

Sponsors & Collaborators

  • National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

    collaborator NIH
  • Children's Hospital Medical Center, Cincinnati

    lead OTHER

Principal Investigators

  • Susmita Kashikar-Zuck, PhD · Children's Hospital Medical Center, Cincinnati

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-01-02
Primary Completion
2023-12-21
Completion
2023-12-21

Countries

  • United States
  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03268421 on ClinicalTrials.gov