Self-management for Mobility Improvement in the ElderlySSSNCT01792180
The Senior Step Study How Elderly Help Themselves Maximally Forward
A study testing Mobility feedback device with use of instruction book in people with Self-management for Mobility Improvement in the Elderly, run by Radboud University Medical Center at 1 site in Netherlands.
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. Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Self-management for Mobility Improvement in the Elderly
- What is being tested?
- Mobility feedback device with use of instruction book
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteNetherlands
- Study dates
- Jan 2013to 1 Apr 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Radboud University Nijmegen Medical Centre
Nijmegen, Gelderland, 6500 HB
About this study
Official title: 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.
Read the 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.
- Being tested
- Mobility feedback device with use of instruction book
- Keywords
- Gait speed, Mobility, Falls, Fall risk, Self-management, Mental wellbeing, Elderly
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobility feedback device with use of instruction bookBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | No intervention besides weekly telephone calls from the computerized falls telephone system |
| Intervention group | Experimental | Weekly use of the mobility feedback device, use of instruction book with every day exercises, use of activity diary in intervention group. Receives: Behavioral: Mobility feedback device with use of instruction book |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mental wellbeing
Medical Outcomes Study (MOS-20)
Measured: Baseline to 3 months
Secondary outcomes (6)
Number of falls
Computerized falls telephone system
Measured: Baseline to 6 months
Self-management
Self-Management Ability Scale (SMAS-30)
Measured: Baseline to 3 months, baseline to 6 months
Physical activity
LASA Physical Activity Questionnaire (LAPAQ)
Measured: Baseline to 3 months, baseline to 6 months
Fear of falling
Falls Efficacy Scale (FES-I)
Measured: Baseline to 3 months, baseline to 6 months
Balance and mobility
Short Physical Perfomance Battery, Timed Up and Go
Measured: Baseline to 3 months, baseline to 6 months
Mental Wellbeing
Medical Outcomes Study (MOS-20)
Measured: Baseline to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2013 (estimated)
- Study startJan 2013
- Primary completion1 Apr 2017
- Study completion1 Apr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Self-management for Mobility Improvement in the ElderlyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development
- Responsible party
- Principal investigator, Marcel Olde Rikkert, Radboud University Medical Center
- Investigators
- Marcel GM Olde Rikkert, Prof PhD MD, Principal investigator, Radboud University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01792180
- Sponsor's protocol ID
- Nr. 60-61900-98-449
- Acronym
- SSS
- Status last verified
- Aug 2018
- First submitted
- 11 Feb 2013
- Last updated
- 29 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: raw data can be shared
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Senior Step Study: How Elderly Help Themselves Maximally Forward
- ClinicalTrials.gov ID
- NCT01792180
- Acronym / sponsor ID
- SSS / Nr. 60-61900-98-449
- Keywords
- Gait speed, Mobility, Falls, Fall risk, Self-management, Mental wellbeing, Elderly
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development
- Study start
- Jan 2013 (actual)
- Primary completion
- 1 Apr 2017 (actual)
- Study completion
- 1 Apr 2017 (actual)
- First posted
- 15 Feb 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –No intervention besides weekly telephone calls from the computerized falls telephone system |
| Intervention group | Experimental | Behavioral: Mobility feedback device with use of instruction bookWeekly use of the mobility feedback device, use of instruction book with every day exercises, use of activity diary in intervention group. |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mobility feedback device with use of instruction bookWeekly 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. | Behavioural | Intervention group |
Primary outcome
Mental wellbeing
Time frame: Baseline to 3 months
Medical Outcomes Study (MOS-20)
6 secondary outcomes
Number of falls
Time frame: Baseline to 6 months
Self-management
Time frame: Baseline to 3 months, baseline to 6 months
Physical activity
Time frame: Baseline to 3 months, baseline to 6 months
Fear of falling
Time frame: Baseline to 3 months, baseline to 6 months
Balance and mobility
Time frame: Baseline to 3 months, baseline to 6 months
Mental Wellbeing
Time frame: Baseline to 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2018.
- Individual participant dataSharing planned: No. raw data can be shared
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marcel GM Olde Rikkert, Prof PhD MD principal investigator
Radboud University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mobility feedback device with use of instruction book in people with Self-management for Mobility Improvement in the Elderly, run by Radboud University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mental wellbeing (time frame: Baseline to 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2018.