Trial reportTrials2015
Cognitive behaviour therapy plus aerobic exercise training to increase activity in patients with myotonic dystrophy type 1 (DM1) compared to usual care (OPTIMISTIC): study protocol for randomised controlled trial.
Trial report in Trials, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02118779 (Observational Prolonged Trial in Myotonic Dystrophy Type 1 to Improve Quality of Life Standards, a Target Identification Collaboration), which is not on this map. Cited by 30 papers, 3 of them syntheses that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Observational Prolonged Trial in Myotonic Dystrophy Type 1 to Improve Quality of Life Standards, a Target Identification Collaboration
Who cites it
30 citing papers in PubMed, 3 syntheses or guidelines pooled it, 57 citations in OpenAlex.
- Interventions for promoting physical activity in people with neuromuscular disease.The Cochrane database of systematic reviews · 2021Pooled it
- Strength training and aerobic exercise training for muscle disease.The Cochrane database of systematic reviews · 2019Pooled it
- Measuring Habitual Physical Activity in Neuromuscular Disorders: A Systematic Review.Journal of neuromuscular diseases · 2017Pooled it
- Clinical improvement of DM1 patients reflected by reversal of disease-induced gene expression in blood.BMC medicine · 2022Trial
- Clinical Outcome Evaluations and CBT Response Prediction in Myotonic Dystrophy.Journal of neuromuscular diseases · 2021Trial
- Genetic determinants of disease severity in the myotonic dystrophy type 1 OPTIMISTIC cohort.Neurology · 2019Trial
- Clinically Suspected Myotonic Dystrophy in Sub-Saharan Africa: A Rare Case Report Highlighting Rehabilitation Challenges.Clinical case reports · 2026Article
- Article
- Effectiveness of the capability approach in rehabilitation for persons with neuromuscular diseases: A controlled before-after study.PloS one · 2025Article
- Resistance Exercise Training Rescues Mitochondrial Dysfunction in Skeletal Muscle of Patients with Myotonic Dystrophy Type 1.Journal of neuromuscular diseases · 2023Article
- Blood Transcriptome Profiling Links Immunity to Disease Severity in Myotonic Dystrophy Type 1 (DM1).International journal of molecular sciences · 2022Article
- Unravelling the impact of frontal lobe impairment for social dysfunction in myotonic dystrophy type 1.Brain communications · 2022Article
- Associations Between Variant Repeat Interruptions and Clinical Outcomes in Myotonic Dystrophy Type 1.Neurology. Genetics · 2021Article
- Article
- Brain Pathogenesis and Potential Therapeutic Strategies in Myotonic Dystrophy Type 1.Frontiers in aging neuroscience · 2021Review
- A Practical Approach to Managing Patients With Myasthenia Gravis-Opinions and a Review of the Literature.Frontiers in neurology · 2020Review
- Analyzing walking speeds with ankle and wrist worn accelerometers in a cohort with myotonic dystrophy.Disability and rehabilitation · 2019Article
- Analysis of the functional capacity outcome measures for myotonic dystrophy.Annals of clinical and translational neurology · 2019Article
- MSH3 modifies somatic instability and disease severity in Huntington's and myotonic dystrophy type 1.Brain : a journal of neurology · 2019Article
- Lower extremity muscle pathology in myotonic dystrophy type 1 assessed by quantitative MRI.Neurology · 2019Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
2 authors at 1 institution in 1 country.
Funding
Abstract
backgroundMyotonic dystrophy type 1 (DM1) is a rare, inherited chronic progressive disease as well as an autosomal dominant multi-systemic disorder. It is probably one of the most common adult forms of muscular dystrophy, with a prevalence of approximately 10 per 100,000 people affected. With 733 million people in Europe, we estimate that 75,000 people in Europe are affected with DM1. METHODS/
designOPTIMISTIC is a multi-centre, randomised trial designed to compare an intervention comprising cognitive behavioural therapy (CBT) plus graded exercise therapy against standard care. Participants will be recruited from myotonic dystrophy clinics and neuromuscular centres in France, Germany, the Netherlands and the United Kingdom. A sample size of 208 individuals is needed. To allow for some potential loss to follow-up, a total of 296 male and female patients aged 18 years and older with genetically proven classical or adult DM1 and suffering from severe fatigue (only DM1 patients with a Checklist Individual Strength (CIS) subscale fatigue severity score ≥ 35 are likely to benefit from the intervention), able to walk independently and able to complete the trial interventions will be included. The primary outcome of the study is the score on the DM1-Activ scale, which is a measure of activity and participation for patients with DM1. Secondary outcomes include the 6-minute walk test, objective physical activity measured with an accelerometer, quality of life and cognitive measures. The trial will also collect data on potential effect modifiers of the short- and long-term clinical response, including pain, muscular impairment and cognitive-behavioural variables. In addition, OPTIMISTIC will identify genetic factors that predict outcome and potential biomarkers as surrogate outcome measures that best explain the observed clinical variation. DISCUSSION: OPTIMISTIC will not only provide effectiveness data on an intervention that could fill a treatment-gap for DM1 patients but will also improve our understanding of the relevant determinants of the prognosis of DM1.
trial registrationREGISTRATION NUMBER: Cinicaltrials.gov NCT02118779; registered 11 April 2014.
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What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.