Myalgic Encephalomyelitis (ME)NCT07363655
Effects of a Rehabilitation Programme Focused on Energy Management in People With Myalgic Encephalomyelitis / Chronic Fatigue Syndrome
A study testing Intervention Group in people with Myalgic Encephalomyelitis (ME) and Chronic Fatigue Syndrome (CFS), run by Escola Superior de Saúde Norte da Cruz Vermelha Portuguesa at 1 site in Portugal.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myalgic Encephalomyelitis (ME), Chronic Fatigue Syndrome (CFS)
- What is being tested?
- Intervention Group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 sitePortugal
- Study dates
- 9 Oct 2024to 9 Mar 2025
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Portugal1 site
Escola Superior de Saúde Norte da Cruz Vermelha Portuguesa, Portugal.
Oliveira de Azeméis, Aveiro District, 3720-126
About this study
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.
Read the 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.
- Being tested
- Intervention Group
- Keywords
- Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS);, energy management;, pacing, fatigue, physical function, quality of 19 life.)
- Medical subject headings
- Fatigue Syndrome, Chronic, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention GroupBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention arm | Experimental | Not described Receives: Behavioral: Intervention Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional Assessment
Short Form Health Survey: SF 36 v2 (physical dimension)
Measured: 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
Quality-of-life measure: EuroQoL 5D-5L
Measured: Assessment at two time points: M0 - before the start of the intervention; M1 - 12 weeks after the end of the intervention.
Fatigue Assessment
Application of the Chalder Fatigue Scale
Measured: Assessment at two time points: M0 - before the start of the intervention; M1 - 12 weeks after the end of the intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2026
- Study start9 Oct 2024
- Primary completion23 Feb 2025
- Study completion9 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myalgic Encephalomyelitis (ME)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Escola Superior de Saúde Norte da Cruz Vermelha Portuguesa
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07363655
- Sponsor's protocol ID
- 2024.063
- Status last verified
- Jan 2026
- First submitted
- 6 Jan 2026
- Last updated
- 28 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Rehabilitation Programme Focused on Energy Management in People With Myalgic Encephalomyelitis / Chronic Fatigue Syndrome
- ClinicalTrials.gov ID
- NCT07363655
- Acronym / sponsor ID
- 2024.063
- Keywords
- Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS);, energy management;, pacing, fatigue, physical function, quality of 19 life.)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Escola Superior de Saúde Norte da Cruz Vermelha PortuguesaUniversity, hospital or other
- Study start
- 9 Oct 2024 (actual)
- Primary completion
- 23 Feb 2025 (actual)
- Study completion
- 9 Mar 2025 (actual)
- First posted
- 23 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention arm | Experimental | Behavioral: Intervention Group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intervention GroupAn 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. | Behavioural | Intervention arm |
Primary outcome
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)
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.
Quality-of-life measure: EuroQoL 5D-5L
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.
Application of the Chalder Fatigue Scale
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention Group in people with Myalgic Encephalomyelitis (ME) and Chronic Fatigue Syndrome (CFS), run by Escola Superior de Saúde Norte da Cruz Vermelha Portuguesa at 1 site in Portugal.
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 4 inclusion and 4 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 28 Jan 2026. 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 Portugal. 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?
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.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Jan 2026.