- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07363655
Effects of a Rehabilitation Programme Focused on Energy Management in People With Myalgic Encephalomyelitis / Chronic Fatigue Syndrome
January 26, 2026 updated by: Escola Superior de Saúde Norte da Cruz Vermelha Portuguesa
The study focuses on rehabilitation nursing care for adults diagnosed with Myalgic Encephalomyelitis/Chronic Fatigue Syndrome in a home setting.
The objective is to evaluate the effects of an individualised rehabilitation programme, which aims to empower participants to manage their energy effectively, observing the impacts on functionality and fatigue.
Study Overview
Status
Completed
Intervention / Treatment
Detailed Description
During the study, we collected sociodemographic data, information about the clinical evolution, patient perception of the disease.
Instruments were applied to assess quality of life, functionality, and fatigue levels.
This will allow to understand how to improve rehabilitation nursing care.
Study Type
Interventional
Enrollment (Actual)
13
Phase
- 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
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-
Aveiro District
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Oliveira de Azeméis, Aveiro District, Portugal, 3720-126
- Escola Superior de Saúde Norte da Cruz Vermelha Portuguesa, Portugal.
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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
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Portuguese-speaking individuals with age of 18 years or older;
- Individuals with official residence in Portugal;
- An official diagnosis of ME/CFS based on the NICE guidelines;
- A Chalder's Fatigue Questionnaire (CFQ) score higher than 18 points.
Exclusion Criteria:
- Individuals without official residence in Portugal;
- Patients without a diagnosis of ME/CFS;
- Patients with a diagnosis of ME/CFS whose case definitions used was not known;
- Patients without a diagnosis of ME/CFS who had previously participated in any kind of rehabilitation programme, including pacing therapy, cognitive behavioural therapy or graded-exercise therapy.
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: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention arm
|
An educational program focused on energy management and developed by the United Kingdom's NICE.
The overall aim of the intervention was the empowerment of patients with self-management strategies that could help them to maximize their autonomy, independence and daily activities without exceeding their perceived energy reservoir.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Functional Assessment
Time Frame: Assessment at two time points: M0 - before the start of the intervention; M1 - 12 weeks after the end of the intervention.
|
Short Form Health Survey: SF 36 v2 (physical dimension)
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Assessment at two time points: M0 - before the start of the intervention; M1 - 12 weeks after the end of the intervention.
|
|
Quality of Life Measure
Time Frame: Assessment at two time points: M0 - before the start of the intervention; M1 - 12 weeks after the end of the intervention.
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Quality-of-life measure: EuroQoL 5D-5L
|
Assessment at two time points: M0 - before the start of the intervention; M1 - 12 weeks after the end of the intervention.
|
|
Fatigue Assessment
Time Frame: Assessment at two time points: M0 - before the start of the intervention; M1 - 12 weeks after the end of the intervention.
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Application of the Chalder Fatigue Scale
|
Assessment at two time points: M0 - before the start of the intervention; M1 - 12 weeks after the end of the intervention.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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 (Actual)
October 9, 2024
Primary Completion (Actual)
February 23, 2025
Study Completion (Actual)
March 9, 2025
Study Registration Dates
First Submitted
January 6, 2026
First Submitted That Met QC Criteria
January 15, 2026
First Posted (Actual)
January 23, 2026
Study Record Updates
Last Update Posted (Actual)
January 28, 2026
Last Update Submitted That Met QC Criteria
January 26, 2026
Last Verified
January 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2024.063
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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