Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| ZonMw: The Netherlands Organisation for Health Research and Development | OTHER |
| Revalidatiefonds Nederland | UNKNOWN |
| Center of expertise Sneller herstel | UNKNOWN |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Energetic | Experimental | Self management group program aimed at reconditioning and social participation |
|
| Control group | Other | Usual care |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Energetic | Behavioral | Physiotherapy and occupational therapy aimed at reconditioning and social participation. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Canadian Occupational Performance Measure (COPM-satisfaction) | Perceived satisfaction with performance (patient) | 3 months |
| Canadian Occupational Performance Measure (COPM-satisfaction) | Perceived satisfaction with performance (patient) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Edith Cup, dr. | Radboudumc, department Rehabilitation | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Radboudumc | Nijmegen | Gelderland | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34433601 | Derived | 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. | |
| 31570565 | Derived |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D009468 | Neuromuscular Diseases |
| D005221 | Fatigue |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001519 | Behavior |
Not provided
Not provided
| ID | Term |
|---|---|
| D035061 | Control Groups |
| ID | Term |
|---|---|
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D012107 | Research Design |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Control group | Other | Usual care |
|
| 6 months |
| Canadian Occupational Performance Measure (COPM-satisfaction) | Perceived satisfaction with performance (patient) | 15 months |
| 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) | 6 months |
| 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) | 15 months |
| Activity Card Sort (ACS) | Participation measure:% retained activities.(patient) | 3 months |
| Activity Card Sort (ACS) | Participation measure:% retained activities.(patient) | 6 months |
| Activity Card Sort (ACS) | Participation measure:% retained activities.(patient) | 15 months |
| Six Minutes Walking Test (6MWT) | physical endurance, sub-max test. (patient) | 3 months |
| Six Minutes Walking Test (6MWT) | physical endurance, sub-max test. (patient) | 6 months |
| Six Minutes Walking Test (6MWT) | physical endurance, sub-max test. (patient) | 15 months |
| Health care cost | Evaluation health care cost (patient) | 3 months |
| Health care cost | Evaluation health care cost (patient) | 6 months |
| Health care cost | Evaluation health care cost (patient) | 15 months |
| Checklist Individual Strength subscale fatigue (CIS-fatigue) | Impact of fatigue (patient) | 3 months |
| Checklist Individual Strength subscale fatigue (CIS-fatigue) | Impact of fatigue (patient) | 6 months |
| Checklist Individual Strength subscale fatigue (CIS-fatigue) | Impact of fatigue (patient) | 15 months |
| Health-related Quality of Life: Short Form 36 (SF-36) | Quality of life, used for evaluation of cost effectiveness (patient) | 3 months |
| Health-related Quality of Life: Short Form 36 (SF-36) | Quality of life, used for evaluation of cost effectiveness (patient) | 6 months |
| Health-related Quality of Life: Short Form 36 (SF-36) | Quality of life, used for evaluation of cost effectiveness (patient) | 15 months |
| General Self-Efficacy Scale | Evaluation of the perceived self-efficacy (patient) | 3 months |
| General Self-Efficacy Scale | Evaluation of the perceived self-efficacy (patient) | 6 months |
| General Self-Efficacy Scale | Evaluation of the perceived self-efficacy (patient) | 15 months |
| Hospital Anxiety and Depression Scale (HADS) | Anxiety and depression (patient) | 3 months |
| Hospital Anxiety and Depression Scale (HADS) | Anxiety and depression (patient) | 6 months |
| Hospital Anxiety and Depression Scale (HADS) | Anxiety and depression (patient) | 15 months |
| Zarit Burden Inventory (ZBI) | Perceived caregiver burden (caregiver) | 3 months |
| Zarit Burden Inventory (ZBI) | Perceived caregiver burden (caregiver) | 6 months |
| Zarit Burden Inventory (ZBI) | Perceived caregiver burden (caregiver) | 15 months |
| 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. |
| 25913823 | Derived | 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. |
| D008722 | Methods |