NCT01530035

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
41

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2011

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

January 26, 2012

Completed
14 days until next milestone

First Posted

Study publicly available on registry

February 9, 2012

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2012

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2012

Completed
Last Updated

May 5, 2017

Status Verified

May 1, 2017

Enrollment Period

1.6 years

First QC Date

January 26, 2012

Last Update Submit

May 4, 2017

Conditions

Adaptation Reaction

Keywords

cardiacvascularmuscularadaptationssoccer trainingstrength training

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Cardiorespiratory fitness, muscular adaptations, Bloodpressure and Glucose tolerance

    after 16 weeks and one year

Study Arms (4)

soccer training intervention

ACTIVE COMPARATOR
Other: physical training

strength training intervention

OTHER
Other: physical training

control group

NO INTERVENTION

elderly men with no change in daily activities

active soccer control group

NO INTERVENTION

veteran soccer players with a 40 year history of continues soccer playing

Interventions

physical trainingOTHER

training

soccer training interventionstrength training intervention

Eligibility Criteria

Age65 Years - 75 Years
Sexmale
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

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

You may not qualify if:

  • smoking
  • cardiac disease
  • biomechanical disorders
  • cardiac medication

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute of exercise and sports sciences, university of Copenhagen

Copenhagen, 2100, Denmark

Location

Related Publications (4)

  • Andersen TR, Schmidt JF, Pedersen MT, Krustrup P, Bangsbo J. The Effects of 52 Weeks of Soccer or Resistance Training on Body Composition and Muscle Function in +65-Year-Old Healthy Males--A Randomized Controlled Trial. PLoS One. 2016 Feb 17;11(2):e0148236. doi: 10.1371/journal.pone.0148236. eCollection 2016.

    PMID: 26886262DERIVED

  • Andersen TR, Schmidt JF, Nielsen JJ, Randers MB, Sundstrup E, Jakobsen MD, Andersen LL, Suetta C, Aagaard P, Bangsbo J, Krustrup P. Effect of football or strength training on functional ability and physical performance in untrained old men. Scand J Med Sci Sports. 2014 Aug;24 Suppl 1:76-85. doi: 10.1111/sms.12245. Epub 2014 Jun 5.

    PMID: 24903323DERIVED

  • Helge EW, Andersen TR, Schmidt JF, Jorgensen NR, Hornstrup T, Krustrup P, Bangsbo J. Recreational football improves bone mineral density and bone turnover marker profile in elderly men. Scand J Med Sci Sports. 2014 Aug;24 Suppl 1:98-104. doi: 10.1111/sms.12239. Epub 2014 Jun 5.

    PMID: 24903207DERIVED

  • Schmidt JF, Hansen PR, Andersen TR, Andersen LJ, Hornstrup T, Krustrup P, Bangsbo J. Cardiovascular adaptations to 4 and 12 months of football or strength training in 65- to 75-year-old untrained men. Scand J Med Sci Sports. 2014 Aug;24 Suppl 1:86-97. doi: 10.1111/sms.12217. Epub 2014 Jun 5.

    PMID: 24902992DERIVED

MeSH Terms

Interventions

Physical Conditioning, Human

Intervention Hierarchy (Ancestors)

ExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Jens Bangsbo, professor

    Institute of exercise and sports sciences, university of copenhagen Denmark

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD PhD student

Study Record Dates

First Submitted

January 26, 2012

First Posted

February 9, 2012

Study Start

March 1, 2011

Primary Completion

October 1, 2012

Study Completion

November 1, 2012

Last Updated

May 5, 2017

Record last verified: 2017-05

Locations

DK(1)