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CompletedNCT02208687Updated Nov 7, 2017

Effectiveness and Cost-effectiveness of the Energetic Program

An interventional study of Energetic and Control group in Neuromuscular Diseases, sponsored by Radboud University Medical Center. Completed at 1 site in Netherlands. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2017-11-07.

Sponsored by Radboud University Medical Center · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
53
Allocation
Randomized
Ages
18 Years to 85 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Neuromuscular Diseases

Keywords

  • Social Participation
  • Fatigue
  • Self-Management
  • Rehabilitation
  • Physical therapy
  • Occupational therapy
  • Group intervention
  • Exercise
03

In context

Neuromuscular Diseases

300 studies on the registry are indexed under Neuromuscular Diseases; 87 are open to participants now.

This study's enrollment of 53 is above the median of 32 across 168 interventional studies indexed under Neuromuscular Diseases.

Browse Neuromuscular Diseases studies →

Lead sponsor

Radboud University Medical Center is the lead sponsor of 959 studies on the registry; 134 are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
53 participants (actual)

Study arms

  • Experimental
    Energetic

    Self management group program aimed at reconditioning and social participation

    Behavioral: Energetic

  • Other
    Control group

    Usual care

    Other: Control group

Interventions

  • BehavioralEnergetic

    Physiotherapy and occupational therapy aimed at reconditioning and social participation.

  • OtherControl group

    Usual care

06

What researchers measure

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)

    Time frame: 3 months

Secondary outcomes

  1. Canadian Occupational Performance Measure (COPM-satisfaction)

    Perceived satisfaction with performance (patient)

    Time frame: 3 months

  2. Canadian Occupational Performance Measure (COPM-satisfaction)

    Perceived satisfaction with performance (patient)

    Time frame: 6 months

  3. Canadian Occupational Performance Measure (COPM-satisfaction)

    Perceived satisfaction with performance (patient)

    Time frame: 15 months

  4. 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

  5. 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

  6. Activity Card Sort (ACS)

    Participation measure:% retained activities.(patient)

    Time frame: 3 months

  7. Activity Card Sort (ACS)

    Participation measure:% retained activities.(patient)

    Time frame: 6 months

  8. Activity Card Sort (ACS)

    Participation measure:% retained activities.(patient)

    Time frame: 15 months

  9. Six Minutes Walking Test (6MWT)

    physical endurance, sub-max test. (patient)

    Time frame: 3 months

  10. Six Minutes Walking Test (6MWT)

    physical endurance, sub-max test. (patient)

    Time frame: 6 months

  11. Six Minutes Walking Test (6MWT)

    physical endurance, sub-max test. (patient)

    Time frame: 15 months

  12. Health care cost

    Evaluation health care cost (patient)

    Time frame: 3 months

  13. Health care cost

    Evaluation health care cost (patient)

    Time frame: 6 months

  14. Health care cost

    Evaluation health care cost (patient)

    Time frame: 15 months

  15. Checklist Individual Strength subscale fatigue (CIS-fatigue)

    Impact of fatigue (patient)

    Time frame: 3 months

  16. Checklist Individual Strength subscale fatigue (CIS-fatigue)

    Impact of fatigue (patient)

    Time frame: 6 months

  17. Checklist Individual Strength subscale fatigue (CIS-fatigue)

    Impact of fatigue (patient)

    Time frame: 15 months

  18. Health-related Quality of Life: Short Form 36 (SF-36)

    Quality of life, used for evaluation of cost effectiveness (patient)

    Time frame: 3 months

  19. Health-related Quality of Life: Short Form 36 (SF-36)

    Quality of life, used for evaluation of cost effectiveness (patient)

    Time frame: 6 months

  20. Health-related Quality of Life: Short Form 36 (SF-36)

    Quality of life, used for evaluation of cost effectiveness (patient)

    Time frame: 15 months

  21. General Self-Efficacy Scale

    Evaluation of the perceived self-efficacy (patient)

    Time frame: 3 months

  22. General Self-Efficacy Scale

    Evaluation of the perceived self-efficacy (patient)

    Time frame: 6 months

  23. General Self-Efficacy Scale

    Evaluation of the perceived self-efficacy (patient)

    Time frame: 15 months

  24. Hospital Anxiety and Depression Scale (HADS)

    Anxiety and depression (patient)

    Time frame: 3 months

  25. Hospital Anxiety and Depression Scale (HADS)

    Anxiety and depression (patient)

    Time frame: 6 months

  26. Hospital Anxiety and Depression Scale (HADS)

    Anxiety and depression (patient)

    Time frame: 15 months

  27. Zarit Burden Inventory (ZBI)

    Perceived caregiver burden (caregiver)

    Time frame: 3 months

  28. Zarit Burden Inventory (ZBI)

    Perceived caregiver burden (caregiver)

    Time frame: 6 months

  29. Zarit Burden Inventory (ZBI)

    Perceived caregiver burden (caregiver)

    Time frame: 15 months

07

Study locations

1 site
  • Radboudumc
    Nijmegen, Gelderland, Netherlands
08

References and documents

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. PubMed 34433601 ↗
  • 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. doi: 10.1212/WNL.0000000000008713. PubMed 31570565 ↗
  • 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. PubMed 25913823 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 7, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02208687
Lead sponsor
Radboud University Medical Center
Collaborators
ZonMw: The Netherlands Organisation for Health Research and Development, Revalidatiefonds Nederland, Center of expertise Sneller herstel
Responsible party
Sponsor
First posted
Aug 5, 2014
Start date
Aug 2014
Primary completion
Nov 2016
Completion
May 2017
Last update
Nov 7, 2017

Study contacts

Edith Cup, dr.
principal investigator · Radboudumc, department Rehabilitation

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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