Effectiveness and Cost-effectiveness of the Energetic Program

N/ACompletedNCT02208687

Radboud University Medical Center53 enrolled

Overview

Fatigue is present in at least 60% of the patients with a muscle disease and can be the most disabling symptom. In combination with other impairments, this often results in low levels of physical activity and decreased social participation, leading to large societal costs. Energetic is a self-management group program aimed at improving participation and physical endurance in these patients. Our hypothesis is that Energetic results in improved participation and improved physical endurance, less experienced fatigue and better quality of life compared to usual care, without increasing health care costs.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Neuromuscular Diseases

Interventions

EnergeticBEHAVIORAL

Physiotherapy and occupational therapy aimed at reconditioning and social participation.

Control groupOTHER

Usual care

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

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

Locations (1)

Radboudumc

Nijmegen, Gelderland, Netherlands

Outcomes

Primary Outcomes

Canadian Occupational Performance Measure (COPM)

Perceived activity performance. Three months will be the primary analysis. Effects at follow up will be measured at 6 and 12 months (see secondary outcome measures) (patient)

Time frame: 3 months

Secondary Outcomes

Canadian Occupational Performance Measure (COPM-satisfaction)

Perceived satisfaction with performance (patient)

Time frame: 3 months

Canadian Occupational Performance Measure (COPM-satisfaction)

Perceived satisfaction with performance (patient)

Time frame: 6 months

Canadian Occupational Performance Measure (COPM-satisfaction)

Perceived satisfaction with performance (patient)

Time frame: 15 months

Canadian Occupational Performance Measure (COPM-performance)

Perceived performance in activities. Is primary outcome measure at 3 months, but data of 6 and 15 months follow up wil be used in a secondary analysis. (patient)

Time frame: 6 months

Canadian Occupational Performance Measure (COPM-performance)

Perceived performance in activities. Is primary outcome measure at 3 months, but data of 6 and 15 months follow up wil be used in a secondary analysis. (patient)

Time frame: 15 months

Activity Card Sort (ACS)

Participation measure:% retained activities.(patient)

Time frame: 3 months

Data from ClinicalTrials.gov

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