Cardiovascular and Muscular Adaptations to Recreational Soccer and Strength Training in Elderly Healthy 65-75-year-old Men

May 4, 2017 updated by: Jakob Friis Schmidt, University of Copenhagen
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

41

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Copenhagen, Denmark, 2100
        • Institute of exercise and sports sciences, university of Copenhagen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years to 75 years (Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: soccer training intervention
Other: physical training
training
Other: strength training intervention
Other: physical training
training
No Intervention: control group
elderly men with no change in daily activities
No Intervention: active soccer control group
veteran soccer players with a 40 year history of continues soccer playing

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
cardiac adaptations
Time Frame: after 16 weeks and one year
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cardiorespiratory fitness, muscular adaptations, Bloodpressure and Glucose tolerance
Time Frame: after 16 weeks and one year

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Copenhagen

Investigators

  • Study Chair: Jens Bangsbo, professor, Institute of exercise and sports sciences, university of copenhagen Denmark

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2011

Primary Completion (Actual)

October 1, 2012

Study Completion (Actual)

November 1, 2012

Study Registration Dates

First Submitted

January 26, 2012

First Submitted That Met QC Criteria

February 8, 2012

First Posted (Estimate)

February 9, 2012

Study Record Updates

Last Update Posted (Actual)

May 5, 2017

Last Update Submitted That Met QC Criteria

May 4, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • H-1-2011-013

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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