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Neuromuscular DiseasesNCT02208687

Effectiveness and Cost-effectiveness of the Energetic Program

A study testing Energetic in people with Neuromuscular Diseases, run by Radboud University Medical Center at 1 site in Netherlands.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 85 years
Conditions the study is for
Neuromuscular Diseases
What is being tested?
Energetic
Could I receive a placebo?
No, everyone receives an active treatment
How many people
53 participants
Where
1 siteNetherlands
Study dates
Aug 2014to May 2017
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Netherlands1 site

  • Radboudumc

    Nijmegen, Gelderland

Other trials in Netherlands

About this study

Official title: 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.

Being tested
Energetic, Control group
Keywords
Social Participation, Fatigue, Self-Management, Rehabilitation, Physical therapy, Occupational therapy, Group intervention, Exercise
Medical subject headings
Neuromuscular Diseases, Fatigue, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EnergeticBehavioural

    Physiotherapy and occupational therapy aimed at reconditioning and social participation.

  • Control groupOther

    Usual care

Study groups in NCT02208687
Study groupRoleWhat they receive
EnergeticExperimentalSelf management group program aimed at reconditioning and social participation
Receives: Behavioral: Energetic
Control groupOtherUsual care
Receives: Other: Control group

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)

    Measured: 3 months

Secondary outcomes (29)

  1. Canadian Occupational Performance Measure (COPM-satisfaction)

    Perceived satisfaction with performance (patient)

    Measured: 3 months

  2. Canadian Occupational Performance Measure (COPM-satisfaction)

    Perceived satisfaction with performance (patient)

    Measured: 6 months

  3. Canadian Occupational Performance Measure (COPM-satisfaction)

    Perceived satisfaction with performance (patient)

    Measured: 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)

    Measured: 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)

    Measured: 15 months

  6. Activity Card Sort (ACS)

    Participation measure:% retained activities.(patient)

    Measured: 3 months

  7. Activity Card Sort (ACS)

    Participation measure:% retained activities.(patient)

    Measured: 6 months

  8. Activity Card Sort (ACS)

    Participation measure:% retained activities.(patient)

    Measured: 15 months

  9. Six Minutes Walking Test (6MWT)

    physical endurance, sub-max test. (patient)

    Measured: 3 months

  10. Six Minutes Walking Test (6MWT)

    physical endurance, sub-max test. (patient)

    Measured: 6 months

  11. Six Minutes Walking Test (6MWT)

    physical endurance, sub-max test. (patient)

    Measured: 15 months

  12. Health care cost

    Evaluation health care cost (patient)

    Measured: 3 months

  13. Health care cost

    Evaluation health care cost (patient)

    Measured: 6 months

  14. Health care cost

    Evaluation health care cost (patient)

    Measured: 15 months

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

    Impact of fatigue (patient)

    Measured: 3 months

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

    Impact of fatigue (patient)

    Measured: 6 months

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

    Impact of fatigue (patient)

    Measured: 15 months

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

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

    Measured: 3 months

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

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

    Measured: 6 months

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

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

    Measured: 15 months

  21. General Self-Efficacy Scale

    Evaluation of the perceived self-efficacy (patient)

    Measured: 3 months

  22. General Self-Efficacy Scale

    Evaluation of the perceived self-efficacy (patient)

    Measured: 6 months

  23. General Self-Efficacy Scale

    Evaluation of the perceived self-efficacy (patient)

    Measured: 15 months

  24. Hospital Anxiety and Depression Scale (HADS)

    Anxiety and depression (patient)

    Measured: 3 months

  25. Hospital Anxiety and Depression Scale (HADS)

    Anxiety and depression (patient)

    Measured: 6 months

  26. Hospital Anxiety and Depression Scale (HADS)

    Anxiety and depression (patient)

    Measured: 15 months

  27. Zarit Burden Inventory (ZBI)

    Perceived caregiver burden (caregiver)

    Measured: 3 months

  28. Zarit Burden Inventory (ZBI)

    Perceived caregiver burden (caregiver)

    Measured: 6 months

  29. Zarit Burden Inventory (ZBI)

    Perceived caregiver burden (caregiver)

    Measured: 15 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Aug 2014 (estimated)
  2. Study startAug 2014
  3. Primary completionNov 2016
  4. Study completionMay 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
53 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02208687
Sponsor's protocol ID
2014/077
Status last verified
Apr 2016
First submitted
4 Aug 2014
Last updated
7 Nov 2017
Results posted
No
Data monitoring committee
No

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.

    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

Questions about this trial

What is this clinical trial studying?

A study testing Energetic in people with Neuromuscular Diseases, run by Radboud University Medical Center at 1 site in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Canadian Occupational Performance Measure (COPM) (time frame: 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02208687, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2017; AzTrials last refreshed its copy on 30 Oct 2026.

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