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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01033110
Other study ID # 1-bischoff
Secondary ID
Status Completed
Phase N/A
First received November 25, 2009
Last updated November 6, 2014
Start date January 2010
Est. completion date April 2012

Study information

Verified date November 2014
Source University of Zurich
Contact n/a
Is FDA regulated No
Health authority Switzerland: UZurich
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 108
Est. completion date April 2012
Est. primary completion date April 2012
Accepts healthy volunteers No
Gender Female
Age group 45 Years to 65 Years
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Behavioral:
Exercise and Nutrition Education
Guided nordic walking training and 12 presentations about diet and health.

Locations

Country Name City State
Switzerland University Hospital Zurich, Centre on Aging and Mobility Zurich ZH

Sponsors (1)

Lead Sponsor Collaborator
University of Zurich

Country where clinical trial is conducted

Switzerland, 

Outcome

Type Measure Description Time frame Safety issue
Primary physical performance baseline, 3, 12 and 24 months No
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