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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2012 by University of Copenhagen.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
Jakob Friis Schmidt, University of Copenhagen
ClinicalTrials.gov Identifier:
NCT01530035
First received: January 26, 2012
Last updated: February 8, 2012
Last verified: February 2012
  Purpose

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.


Condition Intervention
Adaptation Reaction
Other: physical training

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Cardiovascular and Muscular Adaptations to Recreational Soccer and Strength Training in Elderly Healthy 65-75-year-old Men

Further study details as provided by University of Copenhagen:

Primary Outcome Measures:
  • cardiac adaptations [ Time Frame: after 16 weeks and one year ] [ Designated as safety issue: No ]
    changes in cardiac function after 16 weeks and one year measured by advanced echocardiography (tissue Doppler and speckle tracking imaging)


Secondary Outcome Measures:
  • 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



Enrollment: 41
Study Start Date: March 2011
Estimated Study Completion Date: November 2012
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: soccer training intervention Other: physical training
training
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

  Eligibility

Ages Eligible for Study:   65 Years to 75 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 65-75 year old men
  • healthy
  • non-smoking
  • non-hypertension
  • non- cardiac disease

Exclusion Criteria:

  • smoking
  • cardiac disease
  • biomechanical disorders
  • cardiac medication
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01530035

Locations
Denmark
Institute of exercise and sports sciences, university of Copenhagen
Copenhagen, Denmark, 2100
Sponsors and Collaborators
University of Copenhagen
Investigators
Study Chair: Jens Bangsbo, professor Institute of exercise and sports sciences, university of copenhagen Denmark
  More Information

No publications provided

Responsible Party: Jakob Friis Schmidt, MD PhD student, University of Copenhagen
ClinicalTrials.gov Identifier: NCT01530035     History of Changes
Other Study ID Numbers: H-1-2011-013
Study First Received: January 26, 2012
Last Updated: February 8, 2012
Health Authority: Denmark: Ethics Committee

Keywords provided by University of Copenhagen:
cardiac
vascular
muscular
adaptations
soccer training
strength training

ClinicalTrials.gov processed this record on September 22, 2014