Activity monitoring and patient-reported outcome measures in ME/CFS patients
A small Norwegian study from the team led by Prof Olav Mella and Dr Oystein Fluge trialled wearable activity trackers and questionnaires to monitor heart rate and activity to aid pacing for people with ME/CFS:
In this study we have observed the course of 27 ME/CFS patients during 6 months’ follow-up without any intervention. It is feasible to use activity trackers for the continuous registration of steps and resting heart rate in a study with ME/CFS patients.
According to feedback from patients, the Fitbit trackers were easy to use, and gave a fair reflection of their physical activity levels…
PROMs – self-report questionnaires which measure the severity or impact of symptoms [MEpedia]
After exploring different combinations of PROMs, activity measures and clinical assessment, we found that the combination of lower SF36-PF and higher DSQ-SF defined patients with more stable symptoms during follow-up in this study with no intervention.
The knowledge from this study could be useful for the design of study protocols and assessments of outcome measures in future interventional studies. We propose including a run-in period with activity tracking and PROMs pre-intervention to evaluate normal fluctuations of the disease in individual patients.
Due to the complexity of symptoms, it is necessary to combine the activity measures with patient-reported outcome measures to assess different aspects of disease.
Research article:
Activity monitoring and patient-reported outcome measures in Myalgic Encephalomyelitis/ Chronic Fatigue Syndrome patients, by Ingrid G Rekeland, Kari Sorland, Ove Bruland, Kristin Risa, Kine Alme, Olav Dahl, Karl J Tronstad, Olav Mella, Oystein Fluge in PLoS One Vol 17, #9, Sep 19, 2022
Research abstract:
Introduction
Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) is a disease with no validated specific and sensitive biomarker, and no standard approved treatment. In this observational study with no intervention, participants used a Fitbit activity tracker. The aims were to explore natural symptom variation, feasibility of continuous activity monitoring, and to compare activity data with patient reported outcome measures (PROMs).
Materials and methods
In this pilot study, 27 patients with mild to severe ME/CFS, of mean age 42.3 years, used the Fitbit Charge 3 continuously for six months.
Patients wore a SenseWear activity bracelet for 7 days at baseline, at 3 and 6 months. At baseline and follow-up they completed the Short Form 36 Health Survey (SF-36) and the DePaul Symptom Questionnaire-Short Form (DSQ-SF).
Results
The mean number of steps per day decreased with increasing ME/CFS severity; mild 5566, moderate 4991 and severe 1998. The day-by-day variation was mean 47% (range 25%-79%). Mean steps per day increased from the first to the second three-month period, 4341 vs 4781 steps, p=0.022.
The maximum differences in outcome measures between 4-week periods (highest vs lowest), were more evident in a group of eight patients with milder disease (baseline SF-36 PF>50 or DSQ-SF<55) as compared to 19 patients with higher symptom burden (SF-36 PF<50 and DSQ-SF>55), for SF-36 PF raw scores: 16.9 vs 3.4 points, and for steps per day: 958 versus 479 steps.
The correlations between steps per day and self-reported SF-36 Physical function, SF-36 Social function, and DSQ-SF were significant. Fitbit recorded significantly higher number of steps than SenseWear. Resting heart rates were stable during six months.
Conclusion
Continuous activity registration with Fitbit Charge 3 trackers is feasible and useful in studies with ME/CFS patients to monitor steps and resting heart rate, in addition to self-reported outcome measures.
