The Senior Step Study How Elderly Help Themselves Maximally Forward (SSS)

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.

Study Overview

• Status: Completed
• Conditions: Self-management for Mobility Improvement in the Elderly
• Intervention / Treatment: Behavioral: Mobility feedback device with use of instruction book

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 Type: Interventional
• Enrollment (Actual): 150
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Gelderland
    • Nijmegen, Gelderland, Netherlands, 6500 HB
      • Radboud University Nijmegen Medical Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 70 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mental wellbeing	Medical Outcomes Study (MOS-20)	Baseline to 3 months

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Compliance and motivation using the intervention	Qualitative research using semi-structured interviews	Baseline to 6 months

Collaborators and Investigators

• Sponsor: Radboud University Medical Center
• Collaborators: ZonMw: The Netherlands Organisation for Health Research and Development
• Investigators: Principal Investigator: Marcel GM Olde Rikkert, Prof PhD MD, Radboud University Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2013
• Primary Completion (Actual): April 1, 2017
• Study Completion (Actual): April 1, 2017

Study Registration Dates

• First Submitted: February 11, 2013
• First Submitted That Met QC Criteria: February 12, 2013
• First Posted (Estimate): February 15, 2013

Study Record Updates

• Last Update Posted (Actual): August 29, 2018
• Last Update Submitted That Met QC Criteria: August 27, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Keywords: Elderly; Mobility; Self-management; Falls; Fall risk; Mental wellbeing; Gait speed
• Other Study ID Numbers: Nr. 60-61900-98-449

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: raw data can be shared