Adaptation ReactionNCT01530035
Cardiovascular and Muscular Adaptations to Recreational Soccer and Strength Training in Elderly Healthy 65-75-year-old Men
A study testing physical training in people with Adaptation Reaction, run by University of Copenhagen at 1 site in Denmark.
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… Read more about this study
- Who is it for?
- Ages 65 to 75 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Adaptation Reaction
- What is being tested?
- physical training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteDenmark
- Study dates
- Mar 2011to Nov 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 75 years
- Men only
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 65-75 year old men
- healthy
- non-smoking
- non-hypertension
- non- cardiac disease
Who cannot join
- smoking
- cardiac disease
- biomechanical disorders
- cardiac medication
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Institute of exercise and sports sciences, university of Copenhagen
Copenhagen, 2100
About this study
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.
- Conditions
- Adaptation Reaction
- Being tested
- physical training
- Keywords
- cardiac, vascular, muscular, adaptations, soccer training, strength training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
physical trainingOther
training
| Study group | Role | What they receive |
|---|---|---|
| soccer training intervention | Active comparator | Not described Receives: Other: physical training |
| strength training intervention | Other | Not described Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
cardiac adaptations
changes in cardiac function after 16 weeks and one year measured by advanced echocardiography (tissue Doppler and speckle tracking imaging)
Measured: after 16 weeks and one year
Secondary outcomes (1)
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
Measured: after 16 weeks and one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2012 (estimated)
- Study startMar 2011
- Primary completionOct 2012
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Adaptation ReactionStudies of the same condition, open and under way.
- More trials run by University of CopenhagenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Copenhagen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jakob Friis Schmidt, University of Copenhagen
- Investigators
- Jens Bangsbo, professor, Study chair, Institute of exercise and sports sciences, university of copenhagen Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01530035
- Sponsor's protocol ID
- H-1-2011-013
- Status last verified
- May 2017
- First submitted
- 26 Jan 2012
- Last updated
- 5 May 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 26886262Andersen 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.
PubMed 24903323Helge 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.
PubMed 24903207Schmidt 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.
PubMed 24902992
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiovascular and Muscular Adaptations to Recreational Soccer and Strength Training in Elderly Healthy 65-75-year-old Men
- ClinicalTrials.gov ID
- NCT01530035
- Acronym / sponsor ID
- H-1-2011-013
- Conditions
- Adaptation Reaction
- Keywords
- cardiac, vascular, muscular, adaptations, soccer training, strength training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- University of CopenhagenUniversity, hospital or other
- Study start
- Mar 2011
- Primary completion
- Oct 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 9 Feb 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 65 to 75 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- 65-75 year old men
- healthy
- non-smoking
- non-hypertension
- non- cardiac disease
Key exclusion criteria (4 listed)
- smoking
- cardiac disease
- biomechanical disorders
- cardiac medication
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| physical trainingtraining | Other | soccer training intervention, strength training intervention |
Primary outcome
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)
1 secondary outcome
Cardiorespiratory fitness, muscular adaptations, Bloodpressure and Glucose tolerance
Time frame: after 16 weeks and one year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2017.
- Derived from this study: PubMed 26886262Andersen 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.
- Derived from this study: PubMed 24903323Andersen 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.
- Derived from this study: PubMed 24903207Helge 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.
- Derived from this study: PubMed 24902992Schmidt 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jens Bangsbo, professor study chair
Institute of exercise and sports sciences, university of copenhagen Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing physical training in people with Adaptation Reaction, run by University of Copenhagen at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cardiac adaptations (time frame: after 16 weeks and one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01530035, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2017.