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.

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 Overview

• Status: Completed
• Conditions: Neuromuscular Diseases
• Intervention / Treatment: Other: Control group; Behavioral: Energetic

• Study Type: Interventional
• Enrollment (Actual): 53
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Gelderland
    • Nijmegen, Gelderland, Netherlands
      • Radboudumc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Energetic; Self management group program aimed at reconditioning and social participation	Behavioral: Energetic; Physiotherapy and occupational therapy aimed at reconditioning and social participation.
Other: Control group; Usual care	Other: Control group; Usual care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Activity Card Sort (ACS)	Participation measure:% retained activities.(patient)	3 months
Canadian Occupational Performance Measure (COPM-satisfaction)	Perceived satisfaction with performance (patient)	3 months
Canadian Occupational Performance Measure (COPM-satisfaction)	Perceived satisfaction with performance (patient)	6 months
Canadian Occupational Performance Measure (COPM-satisfaction)	Perceived satisfaction with performance (patient)	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)	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)	15 months
Activity Card Sort (ACS)	Participation measure:% retained activities.(patient)	6 months
Activity Card Sort (ACS)	Participation measure:% retained activities.(patient)	15 months
Six Minutes Walking Test (6MWT)	physical endurance, sub-max test. (patient)	3 months
Six Minutes Walking Test (6MWT)	physical endurance, sub-max test. (patient)	6 months
Six Minutes Walking Test (6MWT)	physical endurance, sub-max test. (patient)	15 months
Health care cost	Evaluation health care cost (patient)	3 months
Health care cost	Evaluation health care cost (patient)	6 months
Health care cost	Evaluation health care cost (patient)	15 months
Checklist Individual Strength subscale fatigue (CIS-fatigue)	Impact of fatigue (patient)	3 months
Checklist Individual Strength subscale fatigue (CIS-fatigue)	Impact of fatigue (patient)	6 months
Checklist Individual Strength subscale fatigue (CIS-fatigue)	Impact of fatigue (patient)	15 months
Health-related Quality of Life: Short Form 36 (SF-36)	Quality of life, used for evaluation of cost effectiveness (patient)	3 months
Health-related Quality of Life: Short Form 36 (SF-36)	Quality of life, used for evaluation of cost effectiveness (patient)	6 months
Health-related Quality of Life: Short Form 36 (SF-36)	Quality of life, used for evaluation of cost effectiveness (patient)	15 months
General Self-Efficacy Scale	Evaluation of the perceived self-efficacy (patient)	3 months
General Self-Efficacy Scale	Evaluation of the perceived self-efficacy (patient)	6 months
General Self-Efficacy Scale	Evaluation of the perceived self-efficacy (patient)	15 months
Hospital Anxiety and Depression Scale (HADS)	Anxiety and depression (patient)	3 months
Hospital Anxiety and Depression Scale (HADS)	Anxiety and depression (patient)	6 months
Hospital Anxiety and Depression Scale (HADS)	Anxiety and depression (patient)	15 months
Zarit Burden Inventory (ZBI)	Perceived caregiver burden (caregiver)	3 months
Zarit Burden Inventory (ZBI)	Perceived caregiver burden (caregiver)	6 months
Zarit Burden Inventory (ZBI)	Perceived caregiver burden (caregiver)	15 months

Collaborators and Investigators

• Sponsor: Radboud University Medical Center
• Collaborators: ZonMw: The Netherlands Organisation for Health Research and Development; Revalidatiefonds Nederland; Center of expertise Sneller herstel
• Investigators: Principal Investigator: Edith Cup, dr., Radboudumc, department Rehabilitation

Publications and helpful links

General Publications

• 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.
• 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. Erratum In: Neurology. 2020 Mar 3;94(9):414.
• 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.

Study record dates

Study Major Dates

• Study Start: August 1, 2014
• Primary Completion (Actual): November 1, 2016
• Study Completion (Actual): May 1, 2017

Study Registration Dates

• First Submitted: August 4, 2014
• First Submitted That Met QC Criteria: August 4, 2014
• First Posted (Estimate): August 5, 2014

Study Record Updates

• Last Update Posted (Actual): November 7, 2017
• Last Update Submitted That Met QC Criteria: November 6, 2017
• Last Verified: April 1, 2016

More Information

Terms related to this study

• Keywords: Rehabilitation; Exercise; Fatigue; Self-Management; Physical therapy; Occupational therapy; Group intervention; Social Participation
• Additional Relevant MeSH Terms: Nervous System Diseases; Neuromuscular Diseases
• Other Study ID Numbers: 2014/077