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CompletedNCT04195815Updated May 11, 2021

Physical Activity Monitoring in Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS)

An observational study in Chronic Fatigue Syndrome (CFS) and Myalgic Encephalomyelitis (ME), sponsored by Haukeland University Hospital. Completed at 1 site in Norway. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2021-05-11.

Sponsored by Haukeland University Hospital · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
27
Ages
18 Years to 65 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 25 studies in Fatigue Syndrome, Chronic with a site in Norway — 2 open to participants now, 2 under way, none of them phase 3. Fatigue Syndrome, Chronic · Norway.

Started
2020
the only one that year
Observational
5 of 25
1 open now
Registered
22nd of 25
by date
Lead sponsor
7 of 25
Haukeland University Hospital

Among the 25 studies in Fatigue Syndrome, Chronic with a site in Norway, this one is the only one that started in 2020, is one of 5 observational ones, and was the 22nd registered.

Fatigue Syndrome, Chronic

263 studies on the registry are indexed under Fatigue Syndrome, Chronic; 61 are open to participants now.

Browse Fatigue Syndrome, Chronic studies →

Open to participants now

2 of the 25 studies in Fatigue Syndrome, Chronic with a site in Norway are open now. Recruiting first, the newest first:

All 2 open studies →

A study can be open while its sites in Norway have not opened yet or have stopped. Only those recruiting at a site in Norway →

Who these studies take

Of the 43 Fatigue Syndrome, Chronic studies recruiting now, 18 (42%) set no upper age limit and 20 (47%) stop at 75 or younger; 5 take children under 18; 10 take healthy volunteers.

This study: 18 Years to 65 Years · all sexes · no healthy volunteers.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 25 studies in Fatigue Syndrome, Chronic with a site in Norway, or all of them as a file.
02

Study summary

The investigators will assess the feasibility of activity monitoring armbands for continuous measurement of physical activity level in ME/CFS patients, during 6 months follow-up. The main purpose is to assess if continuous measurement of activity level may be incorporated in outcome measures in future clinical interventional trials.

Read the detailed description

The purpose is to assess feasibility of activity monitoring armbands for continuous measurement of physical activity level in patents with Myalgic Encephalopathy/ Chronic Fatigue Syndrome (ME/CFS), during 6 months follow-up.

The investigators will assess which physical activity parameters that best seem to reflect the participant's own perception of activity level, such as mean number of steps per 24 hours.

The investigators will assess the agreement between continuous activity measurements by activity armbands, and self-reported questionnaires for health-related quality of life (SF-36 ver.2) and for ME/CFS symptoms (DSQ-SF).

The investigators will assess the agreement between activity monitoring by armbands, and previously validated activity monitoring bracelets for 5-7 consecutive days, at baseline, at 3 months and at 6 months follow-up.

03

Conditions studied

  • Chronic Fatigue Syndrome (CFS)
  • Myalgic Encephalomyelitis (ME)

Keywords

  • Chronic Fatigue Syndrome
  • Myalgic Encephalomyelitis
  • ME/CFS
  • Physical activity
  • Activity armband
04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Approximately 30 patients with ME/CFS according to Canadian Consensus Criteria (2003) with disease duration at least 2 years, of age 18-65 years

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients wit ME/CFS according to Canadian Consensus Criteria (2003)
  • ME/CFS disease duration at least 2 years
  • Mild, Mild/moderate, Moderate, Moderate/Severe and Severe ME/CFS may be included
  • Signed

Exclusion criteria

Exclusion Criteria:

  • Patients with fatigue, who do not meet the diagnostic "Canadian" criteria (2003) for ME/CFS
  • ME/CFS disease duration \< 24 months
  • Patients where the diagnostic workup uncovers other pathology as possible cause of symptoms
  • Serious endogenous depression
  • Lack of ability to complete the study including follow-up
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
27 participants (actual)
Patient registry
No
Biospecimen retention
Samples with dna
06

What researchers measure

Primary outcomes

  1. Feasibility of activity monitoring armband to assess physical activity in ME/CFS patients

    Feasibility of activity monitoring armbands to assess level of physical activity in ME/CFS patients, with comparison of activity data to self-reported questionnaires for quality of life (SF-36 ver.2) and for ME/CFS symptoms (DSQ-SF)

    Time frame: 6 months

07

Study locations

1 site
  • Haukeland University Hospital
    Bergen, N-5020, Norway
08

References and documents

Publications

  • Rekeland IG, Sorland K, Bruland O, Risa K, Alme K, Dahl O, Tronstad KJ, Mella O, Fluge O. Activity monitoring and patient-reported outcome measures in Myalgic Encephalomyelitis/Chronic Fatigue Syndrome patients. PLoS One. 2022 Sep 19;17(9):e0274472. doi: 10.1371/journal.pone.0274472. eCollection 2022. PubMed 36121803 ↗
09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Mar 2020 to primary completion in Nov 2020, 8 months.

Of 39 non-industry observational studies under Fatigue Syndrome, Chronic, half reached primary completion within 44 months of starting (the median), counting those still running; a quarter within 27 and three quarters within 79. This study's 8 months is below that.

Counting every sponsor, half of 41 studies reached it within 44 months; a quarter within 25 and three quarters within 79.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 10, 2019
First posted
Dec 12, 2019
StartActual
Mar 11, 2020
Primary completionActual
Nov 20, 2020
CompletionActual
Nov 20, 2020
Last update
May 11, 2021
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 11, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04195815
Responsible party
Sponsor
First posted
Dec 12, 2019
Start date
Mar 11, 2020
Primary completion
Nov 20, 2020
Completion
Nov 20, 2020
Last update
May 11, 2021

Study contacts

Olav Mella, MD, Prof
study director · Haukeland University Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2019. You cannot join it, but the record below documents what was studied.

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Discussion

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