Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01792180
Recruitment Status : Completed
First Posted : February 15, 2013
Last Update Posted : August 29, 2018
Sponsor:
Collaborator:
ZonMw: The Netherlands Organisation for Health Research and Development
Information provided by (Responsible Party):
Marcel Olde Rikkert, Radboud University

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.

Condition or disease Intervention/treatment Phase
Self-management for Mobility Improvement in the Elderly Behavioral: Mobility feedback device with use of instruction book Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Supportive Care
Official Title: The Senior Step Study: How Elderly Help Themselves Maximally Forward
Actual Study Start Date : January 2013
Actual Primary Completion Date : April 1, 2017
Actual Study Completion Date : April 1, 2017

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.




Primary Outcome Measures :
  1. Mental wellbeing [ Time Frame: Baseline to 3 months ]
    Medical Outcomes Study (MOS-20)


Secondary Outcome Measures :
  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 Outcome Measures:
  1. Compliance and motivation using the intervention [ Time Frame: Baseline to 6 months ]
    Qualitative research using semi-structured interviews



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   70 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01792180


Locations
Layout table for location information
Netherlands
Radboud University Nijmegen Medical Centre
Nijmegen, Gelderland, Netherlands, 6500 HB
Sponsors and Collaborators
Radboud University
ZonMw: The Netherlands Organisation for Health Research and Development
Investigators
Layout table for investigator information
Principal Investigator: Marcel GM Olde Rikkert, Prof PhD MD Radboud University

Layout table for additonal information
Responsible Party: Marcel Olde Rikkert, Prof dr, Radboud University
ClinicalTrials.gov Identifier: NCT01792180    
Other Study ID Numbers: Nr. 60-61900-98-449
First Posted: February 15, 2013    Key Record Dates
Last Update Posted: August 29, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: raw data can be shared
Keywords provided by Marcel Olde Rikkert, Radboud University:
Gait speed
Mobility
Falls
Fall risk
Self-management
Mental wellbeing
Elderly