Clinical trial NCT01792180: The Senior Step Study How Elderly Help Themselves Maximally Forward
Official title: The Senior Step Study: How Elderly Help Themselves Maximally Forward
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Self-management for Mobility Improvement in the Elderly
Keywords: Gait speed
Mobility
Falls
Fall risk
Self-management
Mental wellbeing
Elderly
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
Collaborators: name: ZonMw: The Netherlands Organisation for Health Research and Development
First posted: 2013-02-15
Enrollment: 150
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The Senior Step Study investigates whether feedback given by a mobility feedback device in combination with an instruction book containing every day exercises, motivates elderly to exercise more. By exercising more participants take charge of their own mobility and fall risk. Senior Step Study studies whether this 'exercising more' positively affects their mobility, fall risk, mental wellbeing, self-management, and quality of life.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Subjects of 70 years and over
* Subjects who experienced at least 1 fall in the previous 12 months
* Subjects who can walk independently or with a walking aid
* Informed consent on the basis of Dutch legislation (WMO)
* During the study subjects cannot participate in a falls prevention course

Exclusion Criteria:

* Subjects not able to speak Dutch
* Subjects not able to understand and remember simple Dutch instructions
* Subjects not capable of using the falls telephone, and do not have an informal caregiver who can answer the falls telephone for them

Primary outcomes:
measure: Mental wellbeing
timeFrame: Baseline to 3 months
Secondary outcomes:
measure: Number of falls
timeFrame: Baseline to 6 months
measure: Self-management
timeFrame: Baseline to 3 months, baseline to 6 months
measure: Physical activity
timeFrame: Baseline to 3 months, baseline to 6 months
measure: Fear of falling
timeFrame: Baseline to 3 months, baseline to 6 months
measure: Balance and mobility
timeFrame: Baseline to 3 months, baseline to 6 months
measure: Mental Wellbeing
timeFrame: Baseline to 6 months
Other outcomes:
measure: Compliance and motivation using the intervention
timeFrame: Baseline to 6 months
Locations:
city: Nijmegen
country: Netherlands
facility: Radboud University Nijmegen Medical Centre
state: Gelderland
Study officials:
affiliation: Radboud University Medical Center
name: Marcel GM Olde Rikkert, Prof PhD MD
role: PRINCIPAL_INVESTIGATOR
References: