NCT02744924

Brief Summary

To develop and implement a physical activity promotion intervention for older adults with or without chronic disease living in an urban environment.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
29

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 12, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 20, 2016

Completed
11 days until next milestone

Study Start

First participant enrolled

May 1, 2016

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
Last Updated

August 22, 2017

Status Verified

August 1, 2017

Enrollment Period

1.1 years

First QC Date

April 12, 2016

Last Update Submit

August 17, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • Physical activity as the average daily number of steps

    Average daily number of steps measured by accelerometry (Actigraph wGT3x) during 1 week

    Change from baseline to 6 months

Secondary Outcomes (6)

  • Physical activity intensity

    Change from baseline to 6 months

  • Exercise capacity (1-minute sit-to-stand test)

    Change from baseline to 6 months

  • Health-related quality of life

    Change from baseline to 6 months

  • Symptoms of anxiety and depression

    Change from baseline to 6 months

  • Health status

    Change from baseline to 6 months

  • +1 more secondary outcomes

Other Outcomes (6)

  • Exploratory outcome: Course of daily number of steps

    Daily number of steps during the intervention period (6 months)

  • Exploratory outcome: Social connections

    Through study completion, an average of 6 months

  • Exploratory outcome: Participant satisfaction (questionnaire, quantitative)

    Assessed at 6 months (follow-up)

  • +3 more other outcomes

Study Arms (1)

Physical activity intervention

EXPERIMENTAL

Participants undergo the community-based physical activity promotion (see Intervention)

Behavioral: Physical activity intervention

Interventions

The 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

Physical activity intervention

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • Symptomatic / unstable cardiovascular disease
  • Cardiac surgery within one year

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Zurich

Zurich, 8001, Switzerland

Location

MeSH Terms

Conditions

Sedentary BehaviorMotor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Milo Puhan, Prof. Dr.

    EBPI, University of Zurich

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 12, 2016

First Posted

April 20, 2016

Study Start

May 1, 2016

Primary Completion

June 1, 2017

Study Completion

June 1, 2017

Last Updated

August 22, 2017

Record last verified: 2017-08

Locations