Skip to content

WHeelchair ExercisE and Lifestyle Study

WHeelchair ExercisE and Lifestyle Study - WHEELS

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON46713
Enrollment
30
Registered
2017-12-15
Start date
2019-01-07
Completion date
Unknown
Last updated
2024-04-15

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

Conditions

'leg amputation' 'lower limb amputation' paraplegia 'spinal cord injury' tetraplegia

Interventions

The participants will use the app to set individual lifestyle goals (aimed at healthy physical activity, eating and relaxation/sleep behaviour) that they then try to achieve. Half of participants wi

Sponsors

Hogeschool van Amsterdam
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Spinal cord injury or lower limb amputation - At least partly wheelchair dependent - Time since clinical rehabilitation * 1 year (chronic phase) - Age * 18 years - Access to a smartphone or tablet with internet connection and able to control it. - Inactivity as defined by a reference score of

Exclusion criteria

Exclusion criteria: - Cognitive impairments that impede use of the mobile lifestyle app. - Physical impairments that impede use of the mobile lifestyle app. - Progressive disease - Psychiatric disorders that impede participation.

Design outcomes

Primary

MeasureTime frame
- Process factors: usability, ease of use and satisfaction with the app. These factors are measured using semi-structured interviews. The app to be developed will consist of 3 modules that focus on: 1) healthy physical behaviour (physical activity); 2) healthy eating habits; and 3) healthy relaxation and sleep habits. For evaluation of these 3 modules the primary study parameters are as follows: Module 1 - Physical activity will be measured using an activity monitor (acceleromete). The participants will wear this monitor as a watch around the wrist for five consecutive days (24 hours a day). The accelerometer data will be collected before, halfway and after the intervention. In addition, physical activity will be measured with an exercise diary that the participants can complete in the app. Module 2 - Total daily energy intake is measured with a 3-day food diary that will be completed before and after the intervention. - Body composition (bio-impedance analysis), body-mass index and waist circumference are measured before and after the intervention. Module 3 - The sleep-wake rhythm will be measured with the same accelerometer with which physical activity is measured. From the accelerometer data the following parameters will be distilled: total sleep time (time in bed), sleep period (actual minutes of sleep), nocturnal awakening and sleep efficiency (ratio between the total sleep time and the sleep period).

Secondary

MeasureTime frame
Secondary study parameters: - Physical activity will be measured with the Physical Activity Scale for Individuals with Physical Disabilities (PASIPD). - Multidimensional fatigue will be measured with the 20 items of the Individual Strength Checklist (CIS20R) - Self-efficacy will be measured with the Dutch version of the General Self Efficacy Scale (10 items) and the Spinal Cord Injury Exercise Self Efficacy Scale (10 items). - Health-related quality of life will be measured with the SF-36E. In this enabled version of the SF-36 the items of the physical functioning scale are adapted for use in wheelchair users.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)