search
Back to results

Effectiveness and Cost-effectiveness of the Energetic Program

Primary Purpose

Neuromuscular Diseases

Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Energetic
Control group
Sponsored by
Radboud University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neuromuscular Diseases focused on measuring Social Participation, Fatigue, Self-Management, Rehabilitation, Physical therapy, Occupational therapy, Group intervention, Exercise

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Radboudumc

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Energetic

Control group

Arm Description

Self management group program aimed at reconditioning and social participation

Usual care

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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

Full Information

First Posted
August 4, 2014
Last Updated
November 6, 2017
Sponsor
Radboud University Medical Center
Collaborators
ZonMw: The Netherlands Organisation for Health Research and Development, Revalidatiefonds Nederland, Center of expertise Sneller herstel
search

1. Study Identification

Unique Protocol Identification Number
NCT02208687
Brief Title
Effectiveness and Cost-effectiveness of the Energetic Program
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.
Study Type
Interventional

2. Study Status

Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
August 2014 (undefined)
Primary Completion Date
November 2016 (Actual)
Study Completion Date
May 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Radboud University Medical Center
Collaborators
ZonMw: The Netherlands Organisation for Health Research and Development, Revalidatiefonds Nederland, Center of expertise Sneller herstel

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neuromuscular Diseases
Keywords
Social Participation, Fatigue, Self-Management, Rehabilitation, Physical therapy, Occupational therapy, Group intervention, Exercise

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
53 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Energetic
Arm Type
Experimental
Arm Description
Self management group program aimed at reconditioning and social participation
Arm Title
Control group
Arm Type
Other
Arm Description
Usual care
Intervention Type
Behavioral
Intervention Name(s)
Energetic
Intervention Description
Physiotherapy and occupational therapy aimed at reconditioning and social participation.
Intervention Type
Other
Intervention Name(s)
Control group
Intervention Description
Usual care
Primary Outcome Measure Information:
Title
Canadian Occupational Performance Measure (COPM)
Description
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 Outcome Measure Information:
Title
Canadian Occupational Performance Measure (COPM-satisfaction)
Description
Perceived satisfaction with performance (patient)
Time Frame
3 months
Title
Canadian Occupational Performance Measure (COPM-satisfaction)
Description
Perceived satisfaction with performance (patient)
Time Frame
6 months
Title
Canadian Occupational Performance Measure (COPM-satisfaction)
Description
Perceived satisfaction with performance (patient)
Time Frame
15 months
Title
Canadian Occupational Performance Measure (COPM-performance)
Description
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
Title
Canadian Occupational Performance Measure (COPM-performance)
Description
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
Title
Activity Card Sort (ACS)
Description
Participation measure:% retained activities.(patient)
Time Frame
3 months
Title
Activity Card Sort (ACS)
Description
Participation measure:% retained activities.(patient)
Time Frame
6 months
Title
Activity Card Sort (ACS)
Description
Participation measure:% retained activities.(patient)
Time Frame
15 months
Title
Six Minutes Walking Test (6MWT)
Description
physical endurance, sub-max test. (patient)
Time Frame
3 months
Title
Six Minutes Walking Test (6MWT)
Description
physical endurance, sub-max test. (patient)
Time Frame
6 months
Title
Six Minutes Walking Test (6MWT)
Description
physical endurance, sub-max test. (patient)
Time Frame
15 months
Title
Health care cost
Description
Evaluation health care cost (patient)
Time Frame
3 months
Title
Health care cost
Description
Evaluation health care cost (patient)
Time Frame
6 months
Title
Health care cost
Description
Evaluation health care cost (patient)
Time Frame
15 months
Title
Checklist Individual Strength subscale fatigue (CIS-fatigue)
Description
Impact of fatigue (patient)
Time Frame
3 months
Title
Checklist Individual Strength subscale fatigue (CIS-fatigue)
Description
Impact of fatigue (patient)
Time Frame
6 months
Title
Checklist Individual Strength subscale fatigue (CIS-fatigue)
Description
Impact of fatigue (patient)
Time Frame
15 months
Title
Health-related Quality of Life: Short Form 36 (SF-36)
Description
Quality of life, used for evaluation of cost effectiveness (patient)
Time Frame
3 months
Title
Health-related Quality of Life: Short Form 36 (SF-36)
Description
Quality of life, used for evaluation of cost effectiveness (patient)
Time Frame
6 months
Title
Health-related Quality of Life: Short Form 36 (SF-36)
Description
Quality of life, used for evaluation of cost effectiveness (patient)
Time Frame
15 months
Title
General Self-Efficacy Scale
Description
Evaluation of the perceived self-efficacy (patient)
Time Frame
3 months
Title
General Self-Efficacy Scale
Description
Evaluation of the perceived self-efficacy (patient)
Time Frame
6 months
Title
General Self-Efficacy Scale
Description
Evaluation of the perceived self-efficacy (patient)
Time Frame
15 months
Title
Hospital Anxiety and Depression Scale (HADS)
Description
Anxiety and depression (patient)
Time Frame
3 months
Title
Hospital Anxiety and Depression Scale (HADS)
Description
Anxiety and depression (patient)
Time Frame
6 months
Title
Hospital Anxiety and Depression Scale (HADS)
Description
Anxiety and depression (patient)
Time Frame
15 months
Title
Zarit Burden Inventory (ZBI)
Description
Perceived caregiver burden (caregiver)
Time Frame
3 months
Title
Zarit Burden Inventory (ZBI)
Description
Perceived caregiver burden (caregiver)
Time Frame
6 months
Title
Zarit Burden Inventory (ZBI)
Description
Perceived caregiver burden (caregiver)
Time Frame
15 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Edith Cup, dr.
Organizational Affiliation
Radboudumc, department Rehabilitation
Official's Role
Principal Investigator
Facility Information:
Facility Name
Radboudumc
City
Nijmegen
State/Province
Gelderland
Country
Netherlands

12. IPD Sharing Statement

Citations:
PubMed Identifier
34433601
Citation
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.
Results Reference
derived
PubMed Identifier
31570565
Citation
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.
Results Reference
derived
PubMed Identifier
25913823
Citation
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.
Results Reference
derived

Learn more about this trial

Effectiveness and Cost-effectiveness of the Energetic Program

We'll reach out to this number within 24 hrs