Effectiveness and Cost-effectiveness of the Energetic Program

November 6, 2017 updated by: Radboud University Medical Center

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
53

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
    • Gelderland
      • Nijmegen, Gelderland, Netherlands
        • Radboudumc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Energetic
Self management group program aimed at reconditioning and social participation
Behavioral: Energetic
Physiotherapy and occupational therapy aimed at reconditioning and social participation.
Other: Control group
Usual care
Other: Control group
Usual care

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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)
3 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Activity Card Sort (ACS)
Time Frame: 3 months
Participation measure:% retained activities.(patient)
3 months
Canadian Occupational Performance Measure (COPM-satisfaction)
Time Frame: 3 months
Perceived satisfaction with performance (patient)
3 months
Canadian Occupational Performance Measure (COPM-satisfaction)
Time Frame: 6 months
Perceived satisfaction with performance (patient)
6 months
Canadian Occupational Performance Measure (COPM-satisfaction)
Time Frame: 15 months
Perceived satisfaction with performance (patient)
15 months
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)
6 months
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)
15 months
Activity Card Sort (ACS)
Time Frame: 6 months
Participation measure:% retained activities.(patient)
6 months
Activity Card Sort (ACS)
Time Frame: 15 months
Participation measure:% retained activities.(patient)
15 months
Six Minutes Walking Test (6MWT)
Time Frame: 3 months
physical endurance, sub-max test. (patient)
3 months
Six Minutes Walking Test (6MWT)
Time Frame: 6 months
physical endurance, sub-max test. (patient)
6 months
Six Minutes Walking Test (6MWT)
Time Frame: 15 months
physical endurance, sub-max test. (patient)
15 months
Health care cost
Time Frame: 3 months
Evaluation health care cost (patient)
3 months
Health care cost
Time Frame: 6 months
Evaluation health care cost (patient)
6 months
Health care cost
Time Frame: 15 months
Evaluation health care cost (patient)
15 months
Checklist Individual Strength subscale fatigue (CIS-fatigue)
Time Frame: 3 months
Impact of fatigue (patient)
3 months
Checklist Individual Strength subscale fatigue (CIS-fatigue)
Time Frame: 6 months
Impact of fatigue (patient)
6 months
Checklist Individual Strength subscale fatigue (CIS-fatigue)
Time Frame: 15 months
Impact of fatigue (patient)
15 months
Health-related Quality of Life: Short Form 36 (SF-36)
Time Frame: 3 months
Quality of life, used for evaluation of cost effectiveness (patient)
3 months
Health-related Quality of Life: Short Form 36 (SF-36)
Time Frame: 6 months
Quality of life, used for evaluation of cost effectiveness (patient)
6 months
Health-related Quality of Life: Short Form 36 (SF-36)
Time Frame: 15 months
Quality of life, used for evaluation of cost effectiveness (patient)
15 months
General Self-Efficacy Scale
Time Frame: 3 months
Evaluation of the perceived self-efficacy (patient)
3 months
General Self-Efficacy Scale
Time Frame: 6 months
Evaluation of the perceived self-efficacy (patient)
6 months
General Self-Efficacy Scale
Time Frame: 15 months
Evaluation of the perceived self-efficacy (patient)
15 months
Hospital Anxiety and Depression Scale (HADS)
Time Frame: 3 months
Anxiety and depression (patient)
3 months
Hospital Anxiety and Depression Scale (HADS)
Time Frame: 6 months
Anxiety and depression (patient)
6 months
Hospital Anxiety and Depression Scale (HADS)
Time Frame: 15 months
Anxiety and depression (patient)
15 months
Zarit Burden Inventory (ZBI)
Time Frame: 3 months
Perceived caregiver burden (caregiver)
3 months
Zarit Burden Inventory (ZBI)
Time Frame: 6 months
Perceived caregiver burden (caregiver)
6 months
Zarit Burden Inventory (ZBI)
Time Frame: 15 months
Perceived caregiver burden (caregiver)
15 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Radboud University Medical Center

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
ZonMw: The Netherlands Organisation for Health Research and Development
Revalidatiefonds Nederland
Center of expertise Sneller herstel

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Edith Cup, dr., Radboudumc, department Rehabilitation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 4, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 4, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 5, 2014

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 7, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 6, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2014/077

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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