The Senior Step Study How Elderly Help Themselves Maximally Forward (SSS)
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|ClinicalTrials.gov Identifier: NCT01792180|
Recruitment Status : Completed
First Posted : February 15, 2013
Last Update Posted : August 29, 2018
|Condition or disease||Intervention/treatment||Phase|
|Self-management for Mobility Improvement in the Elderly||Behavioral: Mobility feedback device with use of instruction book||Not Applicable|
Falling is an important problem among community-dwelling elderly. The number of falls and concomitant health costs will rise within an aging population. Fall related injuries and fear of falling decrease mobility and have a negative impact on social functioning, mood, wellbeing and autonomy. Research from a medical perspective has concentrated on case finding and fall prevention. Currently, insufficient possibilities are available for elderly and caregiver to asses and improve their own mobility and fall risk. The Senior Step Study aims to provide a tool for elderly to improve their self-management abilities in monitoring and improving mobility and fall risk.
The researchers expect that elderly in the intervention group will be more aware of their own mobility and fall risk, and will therefore experience more autonomy, better mental wellbeing, and better quality of life. We expect this to reflect in less demands made on healthcare by the elderly.
150 elderly living at home, in a home for the elderly, and elderly who regularly attend activities in a community home, are asked to participate in the study. During the six months of the study, subjects will receive weekly telephone calls from the computerized falls telephone. The intervention group will measure their normal gait speed measured over 4 meters, using the mobility feedback device once a week, and use the feedback given by this mobility feedback device to perform exercises from the instruction book. Activity diaries allow them to register the type and duration of the exercises.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||150 participants|
|Intervention Model:||Parallel Assignment|
|Primary Purpose:||Supportive Care|
|Official Title:||The Senior Step Study: How Elderly Help Themselves Maximally Forward|
|Actual Study Start Date :||January 2013|
|Actual Primary Completion Date :||April 1, 2017|
|Actual Study Completion Date :||April 1, 2017|
No Intervention: Control group
No intervention besides weekly telephone calls from the computerized falls telephone system
Experimental: Intervention group
Weekly use of the mobility feedback device, use of instruction book with every day exercises, use of activity diary in intervention group.
Behavioral: Mobility feedback device with use of instruction book
Weekly use of the mobility feedback device to measure gait speed. Two infrared sensors will be placed in the line of walking, a photo frame containing a display, symbols and lights will tell the participant when and how to perform the test. Gait speed is shown on the display and will serve as feedback to the participant. Participant can use their gait speed to decide which exercises from the instruction book he performs. Participants will be asked to keep an activity diary.
- Mental wellbeing [ Time Frame: Baseline to 3 months ]Medical Outcomes Study (MOS-20)
- Number of falls [ Time Frame: Baseline to 6 months ]Computerized falls telephone system
- Self-management [ Time Frame: Baseline to 3 months, baseline to 6 months ]Self-Management Ability Scale (SMAS-30)
- Physical activity [ Time Frame: Baseline to 3 months, baseline to 6 months ]LASA Physical Activity Questionnaire (LAPAQ)
- Fear of falling [ Time Frame: Baseline to 3 months, baseline to 6 months ]Falls Efficacy Scale (FES-I)
- Balance and mobility [ Time Frame: Baseline to 3 months, baseline to 6 months ]Short Physical Perfomance Battery, Timed Up and Go
- Mental Wellbeing [ Time Frame: Baseline to 6 months ]Medical Outcomes Study (MOS-20)
- Compliance and motivation using the intervention [ Time Frame: Baseline to 6 months ]Qualitative research using semi-structured interviews
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01792180
|Radboud University Nijmegen Medical Centre|
|Nijmegen, Gelderland, Netherlands, 6500 HB|
|Principal Investigator:||Marcel GM Olde Rikkert, Prof PhD MD||Radboud University|