NCT07363655

Brief 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 impacts on functionality and fatigue.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 9, 2024

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 23, 2025

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 9, 2025

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

January 6, 2026

Completed
17 days until next milestone

First Posted

Study publicly available on registry

January 23, 2026

Completed
Last Updated

January 28, 2026

Status Verified

January 1, 2026

Enrollment Period

5 months

First QC Date

January 6, 2026

Last Update Submit

January 26, 2026

Conditions

Keywords

Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS);energy management;pacingfatiguephysical functionquality of 19 life.)

Outcome Measures

Primary Outcomes (3)

  • Functional Assessment

    Short Form Health Survey: SF 36 v2 (physical dimension)

    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

    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

    Assessment at two time points: M0 - before the start of the intervention; M1 - 12 weeks after the end of the intervention.

Study Arms (1)

Intervention arm

EXPERIMENTAL
Behavioral: Intervention Group

Interventions

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.

Intervention arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Escola Superior de Saúde Norte da Cruz Vermelha Portuguesa, Portugal.

Oliveira de Azeméis, Aveiro District, 3720-126, Portugal

Location

MeSH Terms

Conditions

Fatigue Syndrome, ChronicFatigue

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesEncephalomyelitisNeuroinflammatory DiseasesNervous System DiseasesNeuromuscular DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsSigns and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 6, 2026

First Posted

January 23, 2026

Study Start

October 9, 2024

Primary Completion

February 23, 2025

Study Completion

March 9, 2025

Last Updated

January 28, 2026

Record last verified: 2026-01

Locations