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Effectiveness and Cost-effectiveness of the Energetic Program

NCT ID: NCT02208687

Last Updated: 2017-11-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

53 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-08-31

Study Completion Date

2017-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Neuromuscular Diseases

Keywords

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Social Participation Fatigue Self-Management Rehabilitation Physical therapy Occupational therapy Group intervention Exercise

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Energetic

Self management group program aimed at reconditioning and social participation

Group Type EXPERIMENTAL

Energetic

Intervention Type BEHAVIORAL

Physiotherapy and occupational therapy aimed at reconditioning and social participation.

Control group

Usual care

Group Type OTHER

Control group

Intervention Type OTHER

Usual care

Interventions

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Energetic

Physiotherapy and occupational therapy aimed at reconditioning and social participation.

Intervention Type BEHAVIORAL

Control group

Usual care

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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ZonMw: The Netherlands Organisation for Health Research and Development

OTHER

Sponsor Role collaborator

Revalidatiefonds Nederland

UNKNOWN

Sponsor Role collaborator

Center of expertise Sneller herstel

UNKNOWN

Sponsor Role collaborator

Radboud University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Edith Cup, dr.

Role: PRINCIPAL_INVESTIGATOR

Radboudumc, department Rehabilitation

Locations

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Radboudumc

Nijmegen, Gelderland, Netherlands

Site Status

Countries

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Netherlands

References

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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.

Reference Type DERIVED
PMID: 34433601 (View on PubMed)

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.

Reference Type DERIVED
PMID: 31570565 (View on PubMed)

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.

Reference Type DERIVED
PMID: 25913823 (View on PubMed)

Other Identifiers

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2014/077

Identifier Type: -

Identifier Source: org_study_id