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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01530035
Other study ID # H-1-2011-013
Secondary ID
Status Completed
Phase N/A
First received January 26, 2012
Last updated May 4, 2017
Start date March 2011
Est. completion date November 2012

Study information

Verified date May 2017
Source University of Copenhagen
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

A one-year intervention study of 41 healthy elderly men aged 65-75-years.Of these, 24 subjects are untrained men with no regular training activity for the last 5 years. After medical screening and pre-testing, they will be randomized into a football group (n=9), a strength-training group (n=9) or a sedentary control group (n=6). Additional 17 subjects are recruited from local football clubs and have been active football players for the last 40 years. Training will be performed 3x1 hour per week and evaluation will take place after 0, 3 and 12 months. Primary endpoints will be changes in cardiac and vascular structure and function measured by advanced echocardiography (tissue Doppler and speckle tracking imaging), and peripheral arterial tonometry (Endo--‐PAT device). Secondary endpoints will be evaluation of potential changes in VO2 max, blood pressure, muscle capillaries, lipid profile, circulating catecholamines, body composition, and insulin resistance.


Recruitment information / eligibility

Status Completed
Enrollment 41
Est. completion date November 2012
Est. primary completion date October 2012
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 65 Years to 75 Years
Eligibility Inclusion Criteria:

- 65-75 year old men

- healthy

- non-smoking

- non-hypertension

- non- cardiac disease

Exclusion Criteria:

- smoking

- cardiac disease

- biomechanical disorders

- cardiac medication

Study Design


Related Conditions & MeSH terms


Intervention

Other:
physical training
training

Locations

Country Name City State
Denmark Institute of exercise and sports sciences, university of Copenhagen Copenhagen

Sponsors (1)

Lead Sponsor Collaborator
University of Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Primary cardiac adaptations changes in cardiac function after 16 weeks and one year measured by advanced echocardiography (tissue Doppler and speckle tracking imaging) after 16 weeks and one year
Secondary Cardiorespiratory fitness, muscular adaptations, Bloodpressure and Glucose tolerance Improvements in cardiorespiratory fitness assessed with VO2 max treadmill testing.
Changes in muscular tissue with biopsies from the vastus lateralis muscle. Changes in resting blood pressure in incline postion Changes in glucose tolerance with oral glucose tolerance testing
after 16 weeks and one year
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