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Effects of a community-based multicomponent rehabilitation programme for patients with fibromyalgia: protocol for a randomised controlled trial.

BMJ open
January 1, 1970
Trond Haugmark et al. (5 authors)
Clinical Trial ProtocolJournal ArticleResearch Support, Non-U.S. Gov'tHuman StudyClinical
Study Details

Study Goal

The researchers aimed to investigate the effects of a community-based multicomponent rehabilitation program, including mindfulness-based intervention, on fibromyalgia patients' symptoms and quality of life.

Results Summary

The study design suggests potential benefits of mindfulness combined with physical activity counseling for fibromyalgia patients, but specific results are not yet reported as the trial is ongoing.

Population

Adults aged 20-50 with fibromyalgia, who have been working part-time or full-time in the last 2 years.

Effective Dosage

10 weekly 4-hour group sessions plus a booster session after 6 months.

Duration

10 weeks of intervention plus 12 weeks of physical activity counseling, with follow-up at 12 months.

Interactions

None mentioned

Extracted Claims (10)
InterventionDirectionEndpointPopulationDosageImpactClaim #
community-based multicomponent rehabilitation programme comprising an acceptance-based and mindfulness-based group intervention, the Vitality Training Programme (VTP), followed by tailored physical activity counselling
neutral
Patient Global Impression of Change
People with fibromyalgia (FM)
-
investigate the effects of
#1
community-based multicomponent rehabilitation programme comprising an acceptance-based and mindfulness-based group intervention, the Vitality Training Programme (VTP), followed by tailored physical activity counselling
neutral
self-reported pain
People with fibromyalgia (FM)
-
investigate the effects of
#2
community-based multicomponent rehabilitation programme comprising an acceptance-based and mindfulness-based group intervention, the Vitality Training Programme (VTP), followed by tailored physical activity counselling
neutral
fatigue
People with fibromyalgia (FM)
-
investigate the effects of
#3
community-based multicomponent rehabilitation programme comprising an acceptance-based and mindfulness-based group intervention, the Vitality Training Programme (VTP), followed by tailored physical activity counselling
neutral
sleep quality
People with fibromyalgia (FM)
-
investigate the effects of
#4
community-based multicomponent rehabilitation programme comprising an acceptance-based and mindfulness-based group intervention, the Vitality Training Programme (VTP), followed by tailored physical activity counselling
neutral
psychological distress
People with fibromyalgia (FM)
-
investigate the effects of
#5
community-based multicomponent rehabilitation programme comprising an acceptance-based and mindfulness-based group intervention, the Vitality Training Programme (VTP), followed by tailored physical activity counselling
neutral
mindfulness
People with fibromyalgia (FM)
-
investigate the effects of
#6
community-based multicomponent rehabilitation programme comprising an acceptance-based and mindfulness-based group intervention, the Vitality Training Programme (VTP), followed by tailored physical activity counselling
neutral
health-related quality of life
People with fibromyalgia (FM)
-
investigate the effects of
#7
community-based multicomponent rehabilitation programme comprising an acceptance-based and mindfulness-based group intervention, the Vitality Training Programme (VTP), followed by tailored physical activity counselling
neutral
physical activity
People with fibromyalgia (FM)
-
investigate the effects of
#8
community-based multicomponent rehabilitation programme comprising an acceptance-based and mindfulness-based group intervention, the Vitality Training Programme (VTP), followed by tailored physical activity counselling
neutral
work ability
People with fibromyalgia (FM)
-
investigate the effects of
#9
community-based multicomponent rehabilitation programme comprising an acceptance-based and mindfulness-based group intervention, the Vitality Training Programme (VTP), followed by tailored physical activity counselling
neutral
exercise beliefs and habits
People with fibromyalgia (FM)
-
investigate the effects of
#10
Abstract

INTRODUCTION: People with fibromyalgia (FM) suffer from symptoms such as widespread pain, non-refreshing sleep, fatigue and reduced quality of life. Effects of pharmacological treatment are questionable and non-pharmacological treatments are recommended as first-line therapy. To date the majority of patients with FM in Norway are not offered any targeted treatment. The aim of this randomised controlled trial is to investigate the effects of a community-based multicomponent rehabilitation programme comprising an acceptance-based and mindfulness-based group intervention, the Vitality Training Programme (VTP), followed by tailored physical activity counselling. MATERIALS AND METHODS: General practitioners refer potential participants to a rheumatologist in specialist healthcare for diagnostic clarification and assessment of comorbidities. Inclusion criteria are widespread pain/FM ≥3 months, age 20-50 and work participation (minimum part-time) within the last 2 years. The intervention group attends the VTP comprising 10 weekly 4 hour group sessions plus a booster session after 6 months. Thereafter, they receive 12 weeks of individually tailored physical exercise counselled by physiotherapists at community-based Healthy Life Centers. The control group follows treatment as usual. The primary outcome is Patient Global Impression of Change. Secondary outcomes include self-reported pain, fatigue and sleep quality, psychological distress, mindfulness, health-related quality of life, physical activity, work ability and exercise beliefs and habits. To achieve a power of 80% and allow for 10% dropout, 70 participants are needed in each arm. All analyses will be conducted on intention-to-treat bases and measured as differences between groups at 12 months follow-up. ETHICS AND DISSEMINATION: The study is approved and granted by the Norwegian South-Eastern Regional Health Authority (reference 2016015). Ethics approval was obtained from Regional Committee for Medical and Health Research Ethics (reference 2015/2447/REK sør-øst A). Results will be submitted to appropriate journals and presented in relevant conferences and social media. TRIAL REGISTRATION: ISRCTN 96836577.

Medical Subject Headings (MeSH)
Adaptation, PsychologicalAdultExercise TherapyFemaleFibromyalgiaHumansLogistic ModelsMaleMiddle AgedMindfulnessNorwayPatient Education as TopicProspective StudiesQuality of LifeRandomized Controlled Trials as TopicYoung Adult
Study Links
Quality Scores
SafetyNot Assessed
Efficacy75/10
Quality85/10
Citation Metrics
Total Citations9
Citations/Year1.3
Relative Citation Ratio0.74
NIH Percentile39.3%
Research Impact Scores
APT Score0.50
Weight Score1.71
Normalized Score0.67
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