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Table 1 Outcome measures

From: A protocol for a randomised double-blind placebo-controlled feasibility study to determine whether the daily consumption of flavonoid-rich pure cocoa has the potential to reduce fatigue in people with relapsing and remitting multiple sclerosis (RRMS)

Domain to be measured

Outcome measure(s)

Time required

When

Measures of overall health and questionnaires

 1. Health questionnaire and health assessment

General medicine use/health problems, etc.

10 min

1

 2. Global fatigue

Neuro quality of life

5 min

1, 2, 3

 3. Limitations in daily activity

Barthel Activities in Daily Living Index

5 min

1

 4. Quality of life measure

EuroQOL 5D5L and Problem Based Multiple Sclerosis Index

5 min

1, 2, 3

 5. Dietary recall

Monitor diet patterns

10 min

1, 2, 3

 6. Consent

Verbal followed by written

10 min

1

 8. Speed of information processing

The Adult Memory and Information Processing Battery

5 min

1, 2, 3

 9. Depression

Hospital Anxiety and Depression Scale

5 min

1, 2, 3

 10. Physical activity

Physical Activity Survey for the Elderly

10 min

1

 11. Fatigue

Fatigue Severity Scale

5 min

1

Measures of activity and fatigue

 11. 6-min walk

Fatigue

6 min

1, 3

 12. Accelerometer

Activity

2 weeks and 3 days throughout intervention

–

 13. Numerical Rating Scale for fatigue

Fatigue

3 times daily for 6 weeks

–

Measures of plasma markers

 14. Venous blood samples

Inflammation, oxidative stress, antioxidant capacity of plasma

5 min

1, 2, 3

  1. 1 = baseline assessment; 2 = assessment 2 (3 weeks); 3 = assessment 3 (6 weeks)