SedentaryNCT02744924
Intervention to Increase Physical Activity in Older Adults Using Citizen-science and Modern Technology
A study testing Physical activity intervention in people with Sedentary and Elderly, run by University of Zurich at 1 site in Switzerland.
Trial summary
To develop and implement a physical activity promotion intervention for older adults with or without chronic disease living in an urban environment. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sedentary, Elderly, Physical Activity
- What is being tested?
- Physical activity intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteSwitzerland
- Study dates
- May 2016to Jun 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 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 60 years or older
- Living within or <5km from Wetzikon (Zurich area)
- Understand and speak German
- Number of repetitions in the 1-min sit-to-stand test below the 75th percentile compared to the Swiss population (age and sex-specific reference values)
Who cannot join
- Symptomatic / unstable cardiovascular disease
- Cardiac surgery within one year
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Community-based Intervention to Increase Physical Activity Levels in Older Adults Using Citizen-science and Modern Technology
To develop and implement a physical activity promotion intervention for older adults with or without chronic disease living in an urban environment.
Read the detailed description
The World Health organization recommends that all adults should aim for 30 minutes of moderate physical activity on at least five days of the week. The importance of physical activity for promoting heath is complicated when considering inactive older adults and chronic conditions. A problematic cycle emerges where physical inactivity increases the likelihood for developing chronic conditions, and, in turn, many chronic conditions are associated with symptoms that make physical activity more difficult.
The investigators aim to develop and implement a physical activity promotion intervention for older adults with or without chronic disease living in an urban environment that considers individual, interpersonal and environmental factors and makes use of a citizen-science approach and modern PA-monitoring devices.
- Conditions
- Sedentary, Elderly, Physical Activity
- Being tested
- Physical activity intervention
- Medical subject headings
- Sedentary Behavior, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical activity interventionBehavioural
The intervention is comprised of 5 steps:
- Goal setting: Over a step-counter (smartphone app) participants learn about their daily average step count. They are coached to set individual goals
- Fitness assessment: To recommend suitable frequency and intensity of walking program using mapped trails
- Structured walking groups: Promoted and communicated via app. Participants can additionally organize walking groups of their own.
- Feedback: Participants will see individual and group data over the step-counter app, and they can communicate with others via a communication app. They will be incentivized to reach goals through a gamification approach.
- Invite friends: After 12 weeks, participants are encouraged to invite people who fulfil the inclusion criteria to join the project
| Study group | Role | What they receive |
|---|---|---|
| Physical activity intervention | Experimental | Participants undergo the community-based physical activity promotion (see Intervention) Receives: Behavioral: Physical activity intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical activity as the average daily number of steps
Average daily number of steps measured by accelerometry (Actigraph wGT3x) during 1 week
Measured: Change from baseline to 6 months
Secondary outcomes (6)
Physical activity intensity
Time spent in moderate-to-vigorous physical activity (min/day) measured by accelerometry (Actigraph wGT3x) during 1 week
Measured: Change from baseline to 6 months
Exercise capacity (1-minute sit-to-stand test)
Number of repetitions performed in the 1-minute sit-to-stand test
Measured: Change from baseline to 6 months
Health-related quality of life
Assessed by the EQ-5D
Measured: Change from baseline to 6 months
Symptoms of anxiety and depression
Assessed by the Hospital Anxiety and Depression Scale
Measured: Change from baseline to 6 months
Health status
Assessed by the Feeling Thermometer
Measured: Change from baseline to 6 months
Perceived social support
Assessed by the short version of the Social Support Questionnaire
Measured: Change from 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 posted20 Apr 2016 (estimated)
- Study startMay 2016
- Primary completionJun 2017
- Study completionJun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SedentaryStudies of the same condition, open and under way.
- More trials run by University of ZurichThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Milo Puhan, Prof. Dr., Principal investigator, EBPI, University of Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02744924
- Sponsor's protocol ID
- CAPACITY
- Status last verified
- Aug 2017
- First submitted
- 12 Apr 2016
- Last updated
- 22 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Community-based Intervention to Increase Physical Activity Levels in Older Adults Using Citizen-science and Modern Technology
- ClinicalTrials.gov ID
- NCT02744924
- Acronym / sponsor ID
- CAPACITY
- Conditions
- Sedentary, Elderly, Physical Activity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- May 2016 (actual)
- Primary completion
- Jun 2017 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 20 Apr 2016 (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.
To develop and implement a physical activity promotion intervention for older adults with or without chronic disease living in an urban environment.
Detailed description
The World Health organization recommends that all adults should aim for 30 minutes of moderate physical activity on at least five days of the week. The importance of physical activity for promoting heath is complicated when considering inactive older adults and chronic conditions. A problematic cycle emerges where physical inactivity increases the likelihood for developing chronic conditions, and, in turn, many chronic conditions are associated with symptoms that make physical activity more difficult.
The investigators aim to develop and implement a physical activity promotion intervention for older adults with or without chronic disease living in an urban environment that considers individual, interpersonal and environmental factors and makes use of a citizen-science approach and modern PA-monitoring devices.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Physical activity intervention | Experimental | Behavioral: Physical activity interventionParticipants undergo the community-based physical activity promotion (see Intervention) |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 60 years or older
- Living within or <5km from Wetzikon (Zurich area)
- Understand and speak German
- Number of repetitions in the 1-min sit-to-stand test below the 75th percentile compared to the Swiss population (age and sex-specific reference values)
Key exclusion criteria (2 listed)
- Symptomatic / unstable cardiovascular disease
- Cardiac surgery within one year
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 |
|---|---|---|
| Physical activity interventionThe intervention is comprised of 5 steps: 1. Goal setting: Over a step-counter (smartphone app) participants learn about their daily average step count. They are coached to set individual goals 2. Fitness assessment: To recommend suitable frequency and intensity of walking program using mapped trails 3. Structured walking groups: Promoted and communicated via app. Participants can additionally organize walking groups of their own. 4. Feedback: Participants will see individual and group data over the step-counter app, and they can communicate with others via a communication app. They will be incentivized to reach goals through a gamification approach. 5. Invite friends: After 12 weeks, participants are encouraged to invite people who fulfil the inclusion criteria to join the project | Behavioural | Physical activity intervention |
Primary outcome
Physical activity as the average daily number of steps
Time frame: Change from baseline to 6 months
Average daily number of steps measured by accelerometry (Actigraph wGT3x) during 1 week
6 secondary outcomes
Physical activity intensity
Time frame: Change from baseline to 6 months
Exercise capacity (1-minute sit-to-stand test)
Time frame: Change from baseline to 6 months
Health-related quality of life
Time frame: Change from baseline to 6 months
Symptoms of anxiety and depression
Time frame: Change from baseline to 6 months
Health status
Time frame: Change from baseline to 6 months
Perceived social support
Time frame: Change from 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 22 Aug 2017.
- Individual participant dataSharing planned: Undecided
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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.
Milo Puhan, Prof. Dr. principal investigator
EBPI, University of Zurich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical activity intervention in people with Sedentary and Elderly, run by University of Zurich at 1 site in Switzerland.
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 4 inclusion and 2 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 22 Aug 2017. 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 Switzerland. 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?
Physical activity as the average daily number of steps (time frame: Change from baseline to 6 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 22 Aug 2017.