Please select the eligibility criteria that correspond to the clinical trial below.
Title: Observational Prolonged Trial in Myotonic Dystrophy Type 1 to Improve Quality of Life Standards, a Target Identification Collaboration
Brief Summary: Myotonic dystrophy type1 (DM1) is a rare, inherited, chronic progressive disease as well as an autosomal dominant multisystemic disorder. It is the most common adult form 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 are DM1 patients in Europe.

The aim of OPTIMISTIC is to improve clinical practice in the management of patients with this rare disease for which no dedicated treatment is currently available. OPTIMISTIC is a multi-centre, randomised controlled trial designed to compare a two component tailored behavioural change intervention to increase physical activity against standard patient management regimes, with particular attention given to the definition of appropriate outcome measures and new clinical guidelines for DM1 management. The two components of the intervention are 1) cognitive behavioural therapy (CBT) and 2) graded physical activity and we will evaluate the intervention's effectiveness and safety against standard patient management.

Participants will be recruited from myotonic dystrophy clinics and neuromuscular centres in France, Germany, the Netherlands and the UK. A total of 286 male and female patients aged 18 years and older with genetically proven classical or adult DM1 suffering from severe fatigue (only DM1 patients with a CIS subscale fatigue score \> 35 are likely to benefit from the intervention), able to walk independently and able to complete the trial interventions will be included.

A key objective of OPTIMISTIC is to provide outcome measures that are relevant for the patients and have a rate of change that is appropriate for a clinical trial timeframe. In addition, OPTIMISTIC will identify genetic factors that predict outcome and potential biomarkers as surrogate outcome measures that best explain the observed clinical variation.


Options:
A: Inclusion Criteria:

* Able to provide informed consent
* Genetically proven DM1
* Suffering from severe fatigue (CIS fatigue \>35
* Able to walk independently

Exclusion Criteria:

* Neurological or orthopaedic co-morbidity interfering with the interventions or possibly influencing outcomes.
* Use of psychotropic drugs (except Modafinil, Ritalin and antidepressants where the dosing regimen has been stable for at least 12 months prior to screening). If the doses of Modafinil or Ritalin increase during the 10 months of the intervention then the participant will be excluded.
* Severe depression as screening (judged as meeting DSM-IV criteria for a depressive episode).
* Participation in another clinical trial of an investigational medicinal product (CTIMP) or other interventional study considered to influence outcomes being evaluated in OPTIMISTIC.
* Unable to complete study questionnaires.
* Subject participating in another clinical trial (other than observational trials and registries) concurrently or within 30 days prior to screening for entry into this study.
B: Inclusion Criteria:

* Patients with chronic, stable polymyositis or dermatomyositis with diagnosis of definite or probable polymyositis or dermatomyositis (Bohan and Peter 1975)
* Age 18-80 years
* Duration since diagnosis \> 6 months
* Exercising \< once a week,
* Stable disease activity and medication for at least one month.

Ten healthy controls matched for age, gender and physical exercise level will be included.

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Exclusion Criteria:

* Severe pulmonary fibrosis
* Heart or lung conditions that contraindicate vigorous exercise
* Severe osteoporosis
* Not being able to perform the exercise program.
C: Inclusion Criteria:

* formal diagnosis of muscular disease, either FascioScapuloHumeral Dystrophy (FSHD), Inclusion Body Myositis (IBM), Mitochondrial Myopathy (MM) or any other;
* being severely fatigued
* being cardiopulmonary stable and capable of aerobic training (as determined using a submaximal cycling exercise test with ECG (electrocardiography) and advice from a consultant cardiologist and pulmonologist);
* being motivated, committed to the program, and 'ready to change' which is discussed with the patient during the screening by a rehabilitation physician and an occupational therapist; to this end, motivational interviewing will be used (including a advantages/disadvantages matrix; a visual analogue scale (VAS) to rate the importance of participation in de program; and a VAS to rate the confidence a patient has that participation in the program is feasible)
* being able to formulate at least 3 individual participation goals during the interview with the occupational therapist.

Exclusion Criteria:

* active depression or other psychiatric disorder as indicated by a consultant psychologist or by the medical history,
* pregnancy,
* severe co-morbid condition,
* having participated in the Energetic program before
* a travel distance perceived as too burdensome
D: Inclusion Criteria:

* Danish patients with gene verified congenital myopathy

Exclusion Criteria:

* Patients who are to week to train at a cycle-ergometer for 10 weeks
* Patients who have other health issues, which can disturb the interpretation of the efficacy

Answer: A