Effectiveness and Cost-effectiveness of the Energetic Program
Energetic, a Self Management Group Program Aimed at Reconditioning and Social Participation in Persons With a Muscle Disease; a Multicentre Randomized Controlled Trial.
1 other identifier
interventional
53
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Aug 2014
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2014
CompletedFirst Submitted
Initial submission to the registry
August 4, 2014
CompletedFirst Posted
Study publicly available on registry
August 5, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2017
CompletedNovember 7, 2017
April 1, 2016
2.3 years
August 4, 2014
November 6, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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)
3 months
Secondary Outcomes (29)
Canadian Occupational Performance Measure (COPM-satisfaction)
3 months
Canadian Occupational Performance Measure (COPM-satisfaction)
6 months
Canadian Occupational Performance Measure (COPM-satisfaction)
15 months
Canadian Occupational Performance Measure (COPM-performance)
6 months
Canadian Occupational Performance Measure (COPM-performance)
15 months
- +24 more secondary outcomes
Study Arms (2)
Energetic
EXPERIMENTALSelf management group program aimed at reconditioning and social participation
Control group
OTHERUsual care
Interventions
Physiotherapy and occupational therapy aimed at reconditioning and social participation.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Radboudumc
Nijmegen, Gelderland, Netherlands
Related Publications (3)
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.
PMID: 34433601DERIVEDVeenhuizen 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.
PMID: 31570565DERIVEDVeenhuizen 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.
PMID: 25913823DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Edith Cup, dr.
Radboudumc, department Rehabilitation
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 4, 2014
First Posted
August 5, 2014
Study Start
August 1, 2014
Primary Completion
November 1, 2016
Study Completion
May 1, 2017
Last Updated
November 7, 2017
Record last verified: 2016-04