Effects of aerobic exercise therapy and cognitive behavioural therapy on functioning and quality of life in amyotrophic lateral sclerosis: protocol of the FACTS-2-ALS trial

A multicentre, single-blinded, randomized controlled trial with a postponed information model will be conducted. A sample of 120 patients with ALS (1 month post diagnosis) will be recruited from 3 university hospitals and 1 rehabilitation centre. Patients will be randomized to one of three groups i.e. (1) AET + usual care, (2) CBT + usual care, (3) Usual care. AET consists of a 16-week aerobic exercise programme, on 3 days a week. CBT consists of individual psychological support of patients in 5 to 10 sessions over a 16-week period. QoL, functioning and secondary outcome measures will be assessed at baseline, immediately post intervention and at 3- and 6-months follow-up.The FACTS-2-ALS study is the first theory-based randomized controlled trial to evaluate the effects, and the maintenance of effects, of AET and CBT on functioning and QoL in patients with ALS. The results of this study are expected to generate new evidence for the effect of multidisciplinary care of persons with ALS.Dutch Trial Register NTR1616.Amyotrophic lateral sclerosis (ALS) is a fatal progressive neurodegenerative disorder affecting motor neurons in the spinal cord, brainstem, and motor cortex. Patients are afflicted by progressive wasting and weakness of limb, bulbar, and respiratory muscles, and die on average within 3 years after symptom onset, usually because of respiratory failure [1]. In the absence of an established biological marker, the diagnosis of ALS is primarily clinical, based on El Escorial criteria [2]. The median age of onset of ALS is 55 years [1]. The incidence of ALS is between 1.5 and 2.5 per 100,000 person-years of follow-up in industrialized countries [3], and life-time risk of ALS is estimated to be between 1/600 and 1/2000 [1,4], which makes it the most common motor neuron disease.ALS is familial in 5% of cases, with a Mendelian pattern of inheritance. The clinical phenotype of familial ALS (FALS) is similar to that of the sporadic form of the disease. At least 13 gene