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Completed

NCT Number: NCT01792180

The Senior Step Study How Elderly Help Themselves Maximally Forward

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.

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Key information

Age range

70 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Radboud University Nijmegen Medical Centre

Nijmegen, Gelderland, 6500 HB, Netherlands

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mobility feedback device with use of instruction book

Behavioral

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.

Primary outcomes

  1. Mental wellbeing

    Time frame: Baseline to 3 months

    Medical Outcomes Study (MOS-20)

Secondary outcomes

  1. Number of falls

    Time frame: Baseline to 6 months

    Computerized falls telephone system

  2. Self-management

    Time frame: Baseline to 3 months, baseline to 6 months

    Self-Management Ability Scale (SMAS-30)

  3. Physical activity

    Time frame: Baseline to 3 months, baseline to 6 months

    LASA Physical Activity Questionnaire (LAPAQ)

  4. Fear of falling

    Time frame: Baseline to 3 months, baseline to 6 months

    Falls Efficacy Scale (FES-I)

  5. Balance and mobility

    Time frame: Baseline to 3 months, baseline to 6 months

    Short Physical Perfomance Battery, Timed Up and Go

  6. Mental Wellbeing

    Time frame: Baseline to 6 months

    Medical Outcomes Study (MOS-20)

Other outcomes

  1. Compliance and motivation using the intervention

    Time frame: Baseline to 6 months

    Qualitative research using semi-structured interviews

Sponsors and collaborators

Lead sponsor

Radboud University Medical Center

Other

Collaborators

  • ZonMw: The Netherlands Organisation for Health Research and Development

Registry information

Official study title

The Senior Step Study: How Elderly Help Themselves Maximally Forward

Acronym: SSS

Important dates

Study start
2013
Primary completion
2017
Study completion
2017
First posted
Feb 15, 2013
Registry last updated
Aug 29, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.