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Ambulatory feedback on physical activity to CFS patients.

Ambulatory feedback on physical activity to CFS patients.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON26523
Enrollment
30
Registered
2009-07-17
Start date
2009-09-01
Completion date
Unknown
Last updated
2025-03-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

chronische vermoeidheidssyndroom, myalgische encephalomyelitis chronic fatigue syndrome, myalgic encephalomyelitis

Interventions

The intervention will consist of the distribution of ambulatory feedback on the physical activity level by using of a microcomputer of pocket size (PDA) and an accelerometer. The intervention on the p

Sponsors

Roessingh Research and Development b.v.
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Persistent or relapsing unexplained chronic fatigue lasting 6 or more consecutive months (Fukuda et al, 1994); 2. Age between 18-65 years.

Exclusion criteria

Exclusion criteria: 1. In treatment with (pre)clinical hospitalisation for complaints of chronic fatigue during participation in the trial; 2. Wheelchair bounded patients; 3. Pathological disorder diagnosed by general practitioner or medical specialist, which could explain the complaints of chronic fatigue; 4. Insufficient control of the Dutch language.

Design outcomes

Primary

MeasureTime frame
The primary outcome measure is the physical activity level measured with an accelerometer. Firstly, it will be investigated if the average physical activity pattern through the day during the distribution of feedback will come closer to the stipulated norm. Secondly, it will be investigated if the distribution of feedback tips will lead to a changed physical activity level directly after the distributed feedback tip.

Secondary

MeasureTime frame
Secondary parameters are: 1. On the PDA the physical activity level will be scored subjectively on a visual analog scale from 0 till 10, and the questions about the experience and expectation with the feedback tips will be answered with 'yes' or 'no'; 2. The behavioral intention/motivation to follow the given feedback in order to get more balance in the physical activity pattern and determinants which are of influence on the behavioral intention/motivation will be evaluated by means of self drafted questionnaire with items scored on a 7 point scale; 3. The physical activity level will be measured subjectively by means of the Baecke questionnaire; 4. The users satisfaction and usability will be measured with an existing questionnaire containing 9 items scored on a 5 point scale; 5. The extent of fatigue will be measured with the CIS20 questionnaire; 6. Demographical data will be obtained towards age, gender, work status, length of complaints, diagnose of CFS and level of education.

Contacts

Public ContactR.M.H. Evering

Roessingh Research and Development

r.evering@rrd.nl+31 (0)53 4875768

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)