- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01033110
Fit Over 45 - a Health Promotion Project for Inactive Female Hospital Staff Age 45+ From the University Hospital of Zürich
Background:
Despite the well-known benefits of exercise, 64% of the Swiss population do not fulfill the public health recommendation of physical activity. A survey of female staff members over 45 years of age from the University Hospital Zurich at the end of 2003 showed that physical inactivity is also prevalent in this population.
Aim:
To assess whether inactive women working at a large hospital centre prefer Nordic Walking (NW) or a Jogging (J) as a health promotion strategy. (2) To test whether the method chosen by the majority improves physical performance, physical activity, body weight and composition, and bone mineral density.
Methods: The investigators will send out a questionnaire to all female staff members at a large hospital centre age 45 and older, ask whether they are inactive, and whether they prefer Nordic Walking or Jogging as a health promotion strategy. Depending on the preference of the majority of the women, the investigators will then ask inactive female staff members age 45+ to participate in a 12-months randomized controlled trial comparing training plus nutrition education to nutrition education alone. The training will have a 3-month building-up phase followed up by an in part unsupervised training of 9 months. All participants will receive a lecture on healthy nutrition once a months for 12 months. The investigators will assess diet with a food frequency questionnaire at baseline and after 12 and 24 months.
The primary endpoint is: physical performance, measured with the 12-minute Coopertest.
The secondary endpoints are: level of physical activity, body mass index, body composition and bone mineral density at the spine and the hip.
Importance: This project will address the questions which physical activities are preferred by inactive women and whether the preferred training improves physical performance, physical activity, body mass index, body composition and bone mineral density. In addition, our study will explore whether those women who changed their diet in addition to being randomized to the training group have an enhanced benefit.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
ZH
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Zurich, ZH, Switzerland, 8091
- University Hospital Zurich, Centre on Aging and Mobility
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion criteria:
- USZ-staff, at least 45 years old, insufficiently active according to the Swiss recommendation of health enhancing physical activity (neither 30 minutes of moderate physical activity at least five days in the week nor 20 minutes of vigorous physical activity at least two times per week) and written informed consent.
Exclusion criteria:
- Acute osteoporotic fracture (<3 month), disability of the musculoskeletal system or cardiovascular diseases which do not allow an endurance training.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
physical performance
Time Frame: baseline, 3, 12 and 24 months
|
baseline, 3, 12 and 24 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Heike Bischoff Ferrari, MD, MPH, University Hospital Zurich, Centre on Aging and Mobility
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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