Clinical trial NCT02208687: Effectiveness and Cost-effectiveness of the Energetic Program
Official title: Energetic, a Self Management Group Program Aimed at Reconditioning and Social Participation in Persons With a Muscle Disease; a Multicentre Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neuromuscular Diseases
Keywords: Social Participation
Fatigue
Self-Management
Rehabilitation
Physical therapy
Occupational therapy
Group intervention
Exercise
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
Collaborators: name: ZonMw: The Netherlands Organisation for Health Research and Development
name: Revalidatiefonds Nederland
name: Center of expertise Sneller herstel
First posted: 2014-08-05
Enrollment: 53
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Canadian Occupational Performance Measure (COPM)
timeFrame: 3 months
Secondary outcomes:
measure: Canadian Occupational Performance Measure (COPM-satisfaction)
timeFrame: 3 months
measure: Canadian Occupational Performance Measure (COPM-satisfaction)
timeFrame: 6 months
measure: Canadian Occupational Performance Measure (COPM-satisfaction)
timeFrame: 15 months
measure: Canadian Occupational Performance Measure (COPM-performance)
timeFrame: 6 months
measure: Canadian Occupational Performance Measure (COPM-performance)
timeFrame: 15 months
measure: Activity Card Sort (ACS)
timeFrame: 3 months
measure: Activity Card Sort (ACS)
timeFrame: 6 months
measure: Activity Card Sort (ACS)
timeFrame: 15 months
measure: Six Minutes Walking Test (6MWT)
timeFrame: 3 months
measure: Six Minutes Walking Test (6MWT)
timeFrame: 6 months
measure: Six Minutes Walking Test (6MWT)
timeFrame: 15 months
measure: Health care cost
timeFrame: 3 months
measure: Health care cost
timeFrame: 6 months
measure: Health care cost
timeFrame: 15 months
measure: Checklist Individual Strength subscale fatigue (CIS-fatigue)
timeFrame: 3 months
measure: Checklist Individual Strength subscale fatigue (CIS-fatigue)
timeFrame: 6 months
measure: Checklist Individual Strength subscale fatigue (CIS-fatigue)
timeFrame: 15 months
measure: Health-related Quality of Life: Short Form 36 (SF-36)
timeFrame: 3 months
measure: Health-related Quality of Life: Short Form 36 (SF-36)
timeFrame: 6 months
measure: Health-related Quality of Life: Short Form 36 (SF-36)
timeFrame: 15 months
measure: General Self-Efficacy Scale
timeFrame: 3 months
measure: General Self-Efficacy Scale
timeFrame: 6 months
measure: General Self-Efficacy Scale
timeFrame: 15 months
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: 3 months
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: 6 months
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: 15 months
measure: Zarit Burden Inventory (ZBI)
timeFrame: 3 months
measure: Zarit Burden Inventory (ZBI)
timeFrame: 6 months
measure: Zarit Burden Inventory (ZBI)
timeFrame: 15 months
Other outcomes:
Locations:
city: Nijmegen
country: Netherlands
facility: Radboudumc
state: Gelderland
Study officials:
affiliation: Radboudumc, department Rehabilitation
name: Edith Cup, dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Veenhuizen Y, Satink T, Graff MJ, Geurts AC, Groothuis JT, van Engelen BG, Nijhuis-van der Sanden MW, Cup EH. Mixed methods evaluation of a self-management group programme for patients with neuromuscular disease and chronic fatigue. BMJ Open. 2021 Aug 25;11(8):e048890. doi: 10.1136/bmjopen-2021-048890.
citation: Veenhuizen Y, Cup EHC, Jonker MA, Voet NBM, van Keulen BJ, Maas DM, Heeren A, Groothuis JT, van Engelen BGM, Geurts ACH. Self-management program improves participation in patients with neuromuscular disease: A randomized controlled trial. Neurology. 2019 Oct 29;93(18):e1720-e1731. doi: 10.1212/WNL.0000000000008393. Epub 2019 Sep 30.
citation: Veenhuizen Y, Cup EH, Groothuis JT, Hendriks JC, Adang EM, van Engelen BG, Geurts AC. Effectiveness and cost-effectiveness of a self-management group program to improve social participation in patients with neuromuscular disease and chronic fatigue: protocol of the Energetic study. BMC Neurol. 2015 Apr 19;15:58. doi: 10.1186/s12883-015-0314-4.