The Senior Step Study How Elderly Help Themselves Maximally Forward

Not Applicable

Completed

• Conditions: Self-management for Mobility Improvement in the Elderly
• Interventions: Behavioral: Mobility feedback device with use of instruction book

• Registration Number: NCT01792180
• Lead Sponsor: Radboud University Medical Center

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.

Study Timeline

• Study Start: 2013-01
• Study First Submitted: 2013-02-11
• Study First Submitted QC: 2013-02-12
• Study First Posted: 2013-02-15
• Primary Completion: 2017-04-01
• Study Completion: 2017-04-01
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-27
• Last Update Posted: 2018-08-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention group	Mobility feedback device with use of instruction book	Weekly use of the mobility feedback device, use of instruction book with every day exercises, use of activity diary in intervention group.

Primary Outcome Measures

Name	Time	Method
Mental wellbeing	Baseline to 3 months	Medical Outcomes Study (MOS-20)

Secondary Outcome Measures

Name	Time	Method
Number of falls	Baseline to 6 months	Computerized falls telephone system
Self-management	Baseline to 3 months, baseline to 6 months	Self-Management Ability Scale (SMAS-30)
Physical activity	Baseline to 3 months, baseline to 6 months	LASA Physical Activity Questionnaire (LAPAQ)
Fear of falling	Baseline to 3 months, baseline to 6 months	Falls Efficacy Scale (FES-I)
Balance and mobility	Baseline to 3 months, baseline to 6 months	Short Physical Perfomance Battery, Timed Up and Go
Mental Wellbeing	Baseline to 6 months	Medical Outcomes Study (MOS-20)

Trial Locations

Locations (1)

Radboud University Nijmegen Medical Centre; 🇳🇱 Nijmegen, Gelderland, Netherlands