Skip to main content
OpenTrials
Completed

NCT Number: NCT02208687

Effectiveness and Cost-effectiveness of the Energetic Program

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Neuromuscular Diseases Behavior Fatigue Motor Activity Nervous System Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Radboudumc

Nijmegen, Gelderland, Netherlands

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Energetic

Behavioral

Physiotherapy and occupational therapy aimed at reconditioning and social participation.

Control Group

Other

Usual care

Primary outcomes

  1. Canadian Occupational Performance Measure (COPM)

    Time frame: 3 months

    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)

Secondary outcomes

  1. Canadian Occupational Performance Measure (COPM-satisfaction)

    Time frame: 3 months

    Perceived satisfaction with performance (patient)

  2. Canadian Occupational Performance Measure (COPM-satisfaction)

    Time frame: 6 months

    Perceived satisfaction with performance (patient)

  3. Canadian Occupational Performance Measure (COPM-satisfaction)

    Time frame: 15 months

    Perceived satisfaction with performance (patient)

  4. Canadian Occupational Performance Measure (COPM-performance)

    Time frame: 6 months

    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)

  5. Canadian Occupational Performance Measure (COPM-performance)

    Time frame: 15 months

    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. Activity Card Sort (ACS)

    Time frame: 3 months

    Participation measure:% retained activities.(patient)

  7. Activity Card Sort (ACS)

    Time frame: 6 months

    Participation measure:% retained activities.(patient)

  8. Activity Card Sort (ACS)

    Time frame: 15 months

    Participation measure:% retained activities.(patient)

  9. Six Minutes Walking Test (6MWT)

    Time frame: 3 months

    physical endurance, sub-max test. (patient)

  10. Six Minutes Walking Test (6MWT)

    Time frame: 6 months

    physical endurance, sub-max test. (patient)

  11. Six Minutes Walking Test (6MWT)

    Time frame: 15 months

    physical endurance, sub-max test. (patient)

  12. Health care cost

    Time frame: 3 months

    Evaluation health care cost (patient)

  13. Health care cost

    Time frame: 6 months

    Evaluation health care cost (patient)

  14. Health care cost

    Time frame: 15 months

    Evaluation health care cost (patient)

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

    Time frame: 3 months

    Impact of fatigue (patient)

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

    Time frame: 6 months

    Impact of fatigue (patient)

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

    Time frame: 15 months

    Impact of fatigue (patient)

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

    Time frame: 3 months

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

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

    Time frame: 6 months

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

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

    Time frame: 15 months

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

  21. General Self-Efficacy Scale

    Time frame: 3 months

    Evaluation of the perceived self-efficacy (patient)

  22. General Self-Efficacy Scale

    Time frame: 6 months

    Evaluation of the perceived self-efficacy (patient)

  23. General Self-Efficacy Scale

    Time frame: 15 months

    Evaluation of the perceived self-efficacy (patient)

  24. Hospital Anxiety and Depression Scale (HADS)

    Time frame: 3 months

    Anxiety and depression (patient)

  25. Hospital Anxiety and Depression Scale (HADS)

    Time frame: 6 months

    Anxiety and depression (patient)

  26. Hospital Anxiety and Depression Scale (HADS)

    Time frame: 15 months

    Anxiety and depression (patient)

  27. Zarit Burden Inventory (ZBI)

    Time frame: 3 months

    Perceived caregiver burden (caregiver)

  28. Zarit Burden Inventory (ZBI)

    Time frame: 6 months

    Perceived caregiver burden (caregiver)

  29. Zarit Burden Inventory (ZBI)

    Time frame: 15 months

    Perceived caregiver burden (caregiver)

Sponsors and collaborators

Lead sponsor

Radboud University Medical Center

Other

Collaborators

  • Center of expertise Sneller herstel
  • Revalidatiefonds Nederland
  • ZonMw: The Netherlands Organisation for Health Research and Development

Registry information

Official study title

Energetic, a Self Management Group Program Aimed at Reconditioning and Social Participation in Persons With a Muscle Disease; a Multicentre Randomized Controlled Trial.

Important dates

Study start
2014
Primary completion
2016
Study completion
2017
First posted
Aug 5, 2014
Registry last updated
Nov 7, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.