The Senior Step Study How Elderly Help Themselves Maximally Forward

Self-management for Mobility Improvement in the Elderly Clinical Trial

— SSS  

Official title:

The Senior Step Study: How Elderly Help Themselves Maximally Forward

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01792180
• Other study ID #: Nr. 60-61900-98-449
• Status: Completed
• Phase: N/A
• Start date: January 2013
• Est. completion date: April 1, 2017

Study information

• Verified date: August 2018
• Source: Radboud University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: April 1, 2017
• Est. primary completion date: April 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 70 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Self-management for Mobility Improvement in the Elderly

Intervention

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.

Locations

Country	Name	City	State
Netherlands	Radboud University Nijmegen Medical Centre	Nijmegen	Gelderland

Sponsors (2)

Lead Sponsor	Collaborator
Radboud University	ZonMw: The Netherlands Organisation for Health Research and Development

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Compliance and motivation using the intervention	Qualitative research using semi-structured interviews	Baseline to 6 months
Primary	Mental wellbeing	Medical Outcomes Study (MOS-20)	Baseline to 3 months
Secondary	Number of falls	Computerized falls telephone system	Baseline to 6 months
Secondary	Self-management	Self-Management Ability Scale (SMAS-30)	Baseline to 3 months, baseline to 6 months
Secondary	Physical activity	LASA Physical Activity Questionnaire (LAPAQ)	Baseline to 3 months, baseline to 6 months
Secondary	Fear of falling	Falls Efficacy Scale (FES-I)	Baseline to 3 months, baseline to 6 months
Secondary	Balance and mobility	Short Physical Perfomance Battery, Timed Up and Go	Baseline to 3 months, baseline to 6 months
Secondary	Mental Wellbeing	Medical Outcomes Study (MOS-20)	Baseline to 6 months