ElderlyPhase 2NCT01752816
Does Aerobic Training Followed by Resistance Training Enhance Aerobic Capacity in Seniors
A Phase 2 study testing exercise training in people with Elderly, run by University of Southern Denmark at 1 site in Denmark.
Trial summary
In healthy young subjects a single bout of strength training following endurance training has been shown to improve markers for aerobic capacity in muscle compared to a single bout of endurance training alone. Read more about this study
- Who is it for?
- Ages 50 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Elderly
- What is being tested?
- exercise training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteDenmark
- Study dates
- Jan 2012to Apr 2013
- Phase
- Phase 2
- 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 50 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- healthy
- understanding Danish language
Who cannot join
- medical contraindication for training
- taking beta-blockers
- physical exercise training more than 2 hrs per week
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Does Aerobic Training Followed by Resistance Training Enhance Aerobic Capacity in Seniors? A Randomized Controlled Trial.
In healthy young subjects a single bout of strength training following endurance training has been shown to improve markers for aerobic capacity in muscle compared to a single bout of endurance training alone. The present project tests the hypothesis: 12 weeks of training with sessions of endurance training followed by strength training is superior to endurance training alone for health participants 50-65 years of age. The outcome measures are maximal oxygen uptake and knee-extension strength.
- Conditions
- Elderly
- Being tested
- exercise training
- Keywords
- endurance training,, strength training,, aerobic capacity,, muscle strenght, physical capacity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
exercise trainingBehavioural
| Study group | Role | What they receive |
|---|---|---|
| endurance training | Active comparator | 40 min bicycle or treadmill training at 60% maximal oxygen uptake Receives: Behavioral: exercise training |
| Strength following endurance training | Experimental | 20 minutes bicycle or treadmill training at 60% maximal oxygen uptake followed by 20 minutes stength training increasing from 15RM to 10RM Receives: Behavioral: exercise training |
What is being measured
The primary outcome is the main question the study is designed to answer.
maximal oxygen uptake
Measured: 12 weeks
knee extension strength
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2012 (estimated)
- Study startJan 2012
- Primary completionApr 2013
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ElderlyStudies of the same condition, open and under way.
- More trials run by University of Southern DenmarkThe 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 2
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern Denmark
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gisela Sjogaard, University of Southern Denmark
- Investigators
- Gisela Sjøgaard, DrMedSci, Principal investigator, University of Southern Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01752816
- Sponsor's protocol ID
- S-20120178
- Status last verified
- Apr 2013
- First submitted
- 14 Dec 2012
- Last updated
- 15 Aug 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Aerobic Training Followed by Resistance Training Enhance Aerobic Capacity in Seniors? A Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT01752816
- Acronym / sponsor ID
- S-20120178
- Conditions
- Elderly
- Keywords
- endurance training,, strength training,, aerobic capacity,, muscle strenght, physical capacity
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- University of Southern DenmarkUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 19 Dec 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.
In healthy young subjects a single bout of strength training following endurance training has been shown to improve markers for aerobic capacity in muscle compared to a single bout of endurance training alone. The present project tests the hypothesis: 12 weeks of training with sessions of endurance training followed by strength training is superior to endurance training alone for health participants 50-65 years of age. The outcome measures are maximal oxygen uptake and knee-extension strength.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| endurance training | Active comparator | Behavioral: exercise training40 min bicycle or treadmill training at 60% maximal oxygen uptake |
| Strength following endurance training | Experimental | Behavioral: exercise training20 minutes bicycle or treadmill training at 60% maximal oxygen uptake followed by 20 minutes stength training increasing from 15RM to 10RM |
Who may qualify
- Ages
- 50 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- healthy
- understanding Danish language
Key exclusion criteria (3 listed)
- medical contraindication for training
- taking beta-blockers
- physical exercise training more than 2 hrs per week
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 |
|---|---|---|
| exercise training | Behavioural | Strength following endurance training, endurance training |
Primary outcome
maximal oxygen uptake
Time frame: 12 weeks
knee extension strength
Time frame: 12 weeks
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 15 Aug 2013.
- Research Unit: Physical Activity and Health at WorkLink provided by the sponsor.
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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.
Gisela Sjøgaard, DrMedSci principal investigator
University of Southern Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing exercise training in people with Elderly, run by University of Southern Denmark 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 2 inclusion and 3 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 15 Aug 2013. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
maximal oxygen uptake (time frame: 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Aug 2013.