RecruitingACTRN12624001479594

FUNCAP-27 (Functional Capacity), A Repeat Measure Study (FARMS), A survey to establish the utility of the FUNCAP-27 for serial measurements in Myalgic Encephalomyelitis, Chronic Fatigue Syndrome (ME/CFS) and Long Covid

FUNCAP-27 (Functional Capacity), A Repeat Measure Study (FARMS), A validation study utilising a modified FUNCAP 27 for instantaneous serial measurements in the assessment of Myalgic Encephalomyelitis, Chronic Fatigue Syndrome (ME/CFS) and Long Covid


Sponsor

The University of Melbourne

Enrollment

1,000 participants

Start Date

Jun 26, 2025

Study Type

Observational

Conditions

Summary

This is a study to determine if the FUNCAP 27 can be used as an instantaneous measure of perceived functional capacity in those with ME/CFS and Long Covid when at baseline and in a state of PEM(Post Exertional Malaise). We are doing this to establish a measure that can detect short term fluctuations in health that will be used in later interventional clinical trials. We aim to recruit 1000 participants for 2 questionnaires and 1 enrolment survey taking 6-20 minutes at enrolment (including reading the consent forms), 15-35 minutes when well and 10 -20 minutes in PEM. The questionnaire can be completed with the aid of a carer and paused for completion at a later time.


Eligibility

Sex: Both males and femalesMin Age: 18 YearssMax Age: 70 Yearss

Plain Language Summary

Simplified for easier understanding

Myalgic Encephalomyelitis / Chronic Fatigue Syndrome (ME/CFS) and Long COVID are debilitating conditions that cause overwhelming fatigue, post-exertional malaise (feeling significantly worse after any activity), unrefreshing sleep, and brain fog. People living with these conditions experience significant variation in their symptoms day to day and can find it very difficult to track their own functional capacity in a meaningful way. The FUNCAP-27 is a questionnaire designed to measure how much a person with ME/CFS or Long COVID feels they can do on any given day — essentially a snapshot of their perceived functional capacity. This study is testing whether this questionnaire can reliably detect short-term changes, both when a person is at their baseline and when they are experiencing a 'crash' (post-exertional malaise). If reliable, FUNCAP-27 could become a valuable outcome measure in future clinical trials for these conditions. You may be eligible if you are aged 18 to 70 years with an existing diagnosis of ME/CFS and/or Long COVID that meets standard criteria, and have sufficient English proficiency to complete online questionnaires. The questionnaire can be completed with carer assistance and paused if needed. This study involves no in-person visits, medications, or physical procedures — only completing three short online surveys.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

The current FUNCAP 27 has established validation at 4 week intervals. We wish to determine if this questionnaire is useful as a reliable, instantaneous and repeatable measure of perceived functional e

The current FUNCAP 27 has established validation at 4 week intervals. We wish to determine if this questionnaire is useful as a reliable, instantaneous and repeatable measure of perceived functional energy utilisation and consequence capacity. Assessment will take place over 2 situations. The first questionnaire will be completed when experiencing PEM (post exertional malaise) while the second will be completed once returned to baseline level of health and function. This project should take between 30 minutes and 1 hour 20 minutes in total and is comprised of 16 questions at enrolment, 48 questions when in crash or PEM (post exertional malaise) state and 71 questions on the follow up recovered (when well) questionnaire. Participation in this project involves completing an enrolment questionnaire followed by a modified version of the FUNCAP 27 to reflect the measurement of perceived functional capacity, questions about your social and medical circumstances. Questionnaires will be delivered electronically via REDCap software and can be completed by smart phone, tablet or computer. We aim to recruit 1000 participants for this study and encourage the use of carers to assist in completion of the questionnaire. We are hoping to collect answers from all participants over 6 months


Locations(1)

ACT,NSW,NT,QLD,SA,TAS,WA,VIC, Australia

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ACTRN12624001479594