HealthyNCT01931072
Exercise-induced Changes in DNA-methylation
A study testing High-intensity interval training and Moderate training in people with Healthy, run by Norwegian University of Science and Technology at 1 site in Norway.
Trial summary
The purpose of the study was to investigate whether regular moderate- or high-intensity interval training can change the DNA methylation in a long-lasting state, and whether these changes affect the gene expression. Read more about this study
- Who is it for?
- Ages 70 to 75 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- High-intensity interval training and Moderate training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteNorway
- Study dates
- Aug 2012to Dec 2013
- 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 70 to 75 years
- Men only
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Male
- 70-75 years old
- Signed written informed consent
Who cannot join
- Incompatible with exercise
- Known cardiac disease
- Active cancer
- Significant pulmonary disease
- Uncontrolled hypertension
- Use of blood thinning medicine (except Albyl-E)
Show all 9Show fewer
- Drug abuse
- Alcohol abuse
- Finishing less than 80% of the exercise sessions (this complies to the training groups)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Exercise on Maximal Aerobic Capacity, DNA-methylation and Gene Expression in Healthy Elderly Men
The purpose of the study was to investigate whether regular moderate- or high-intensity interval training can change the DNA methylation in a long-lasting state, and whether these changes affect the gene expression. In addition, the investigators will determine whether the intensity of the training could be an affecting factor of the possible DNA-methylation change as well. The null hypothesis was that no such exercise-induced changes occur.
- Conditions
- Healthy
- Being tested
- High-intensity interval training, Moderate training
- Keywords
- Exercise, High-intensity interval training, Moderate training, Healthy elderly, Skeletal muscle, DNA-methylation, Gene expression, subjects
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-intensity interval trainingBehavioural
Interval training 3 times a week for 8 weeks
Moderate trainingBehavioural
Moderate training 3 times a week for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| High-intensity interval training | Experimental | The High-intensity interval training group was instructed to complete exercise sessions of 4x4-minutes intervals at 85-95% of maximal heart rate, 3 times a week for 8 weeks. This type of exercise include 10 minutes warm-up, followed by four intervals of four minutes high-intensity (85-95% of HRmax), with three minutes active breaks (70% of HRmax) between each interval, and ending with seven minutes cool-down. An exercise session last for 42 minutes, where the participants should breathe heavily and feel exhausted four times. Receives: Behavioral: High-intensity interval training |
| Moderate training | Active comparator | The moderate training group was instructed to complete exercise sessions of 50 minutes at 70% of maximal heart rate, 3 times a week for 8 weeks. Receives: Behavioral: Moderate training |
| Control | No intervention | The control group followed the baseline and follow-up tests, and was asked to live normally and not change their dietary pattern or exercise habits during their participation in this project. Based on the well-known beneficial effects of exercise on general health, it was regarded unethical to demand the control group to desist from any types of physical activity during the project period. They got no further follow-up on exercise. |
What is being measured
The primary outcome is the main question the study is designed to answer.
DNA-methylation
From the skeletal muscle biopsies RNA and DNA was isolated, DNA was further bi-sulfite converted and DNA-methylation was analyzed using the Illumina HumanMethylation450 BeadChip. The RNA was further used for gene expression analyses by real-time RTqPCR.
Measured: 8 weeks
Gene Expression
Measured: 8 weeks
Secondary outcomes (1)
Maximal Aerobic Capacity
measured on treadmill at baseline and after eight weeks, also biopsies from Vastus lateralis were sampled.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2013 (estimated)
- Study startAug 2012
- Primary completionDec 2012
- Study completionDec 2013
Why it stopped: inconclusive results, large inter-individual variation, insufficient statistical power
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norwegian University of Science and Technology
- Sponsor type
- University, hospital or other
- Collaborators
- St. Olavs Hospital
- Responsible party
- Sponsor
- Investigators
- Ulrik Wisløff, Professor, Study director, National Taiwan Normal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01931072
- Sponsor's protocol ID
- EPI-GEN100
- Status last verified
- May 2019
- First submitted
- 26 Aug 2013
- Last updated
- 20 May 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Exercise on Maximal Aerobic Capacity, DNA-methylation and Gene Expression in Healthy Elderly Men
- ClinicalTrials.gov ID
- NCT01931072
- Acronym / sponsor ID
- EPI-GEN100
- Conditions
- Healthy
- Keywords
- Exercise, High-intensity interval training, Moderate training, Healthy elderly, Skeletal muscle, DNA-methylation, Gene expression, subjects
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: inconclusive results, large inter-individual variation, insufficient statistical power
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Norwegian University of Science and TechnologyUniversity, hospital or other
- Collaborators
- St. Olavs Hospital
- Study start
- Aug 2012 (actual)
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 29 Aug 2013 (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.
The purpose of the study was to investigate whether regular moderate- or high-intensity interval training can change the DNA methylation in a long-lasting state, and whether these changes affect the gene expression. In addition, the investigators will determine whether the intensity of the training could be an affecting factor of the possible DNA-methylation change as well. The null hypothesis was that no such exercise-induced changes occur.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| High-intensity interval training | Experimental | Behavioral: High-intensity interval trainingThe High-intensity interval training group was instructed to complete exercise sessions of 4x4-minutes intervals at 85-95% of maximal heart rate, 3 times a week for 8 weeks. This type of exercise include 10 minutes warm-up, followed by four intervals of four minutes high-intensity (85-95% of HRmax), with three minutes active breaks (70% of HRmax) between each interval, and ending with seven minutes cool-down. An exercise session last for 42 minutes, where the participants should breathe heavily and feel exhausted four times. |
| Moderate training | Active comparator | Behavioral: Moderate trainingThe moderate training group was instructed to complete exercise sessions of 50 minutes at 70% of maximal heart rate, 3 times a week for 8 weeks. |
| Control | No intervention | –The control group followed the baseline and follow-up tests, and was asked to live normally and not change their dietary pattern or exercise habits during their participation in this project. Based on the well-known beneficial effects of exercise on general health, it was regarded unethical to demand the control group to desist from any types of physical activity during the project period. They got no further follow-up on exercise. |
Who may qualify
- Ages
- 70 to 75 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Male
- 70-75 years old
- Signed written informed consent
Key exclusion criteria (9 listed)
- Incompatible with exercise
- Known cardiac disease
- Active cancer
- Significant pulmonary disease
- Uncontrolled hypertension
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 |
|---|---|---|
| High-intensity interval trainingInterval training 3 times a week for 8 weeks | Behavioural | High-intensity interval training |
| Moderate trainingModerate training 3 times a week for 8 weeks | Behavioural | Moderate training |
Primary outcome
DNA-methylation
Time frame: 8 weeks
From the skeletal muscle biopsies RNA and DNA was isolated, DNA was further bi-sulfite converted and DNA-methylation was analyzed using the Illumina HumanMethylation450 BeadChip. The RNA was further used for gene expression analyses by real-time RTqPCR.
Gene Expression
Time frame: 8 weeks
1 secondary outcome
Maximal Aerobic Capacity
Time frame: 8 weeks
Results and safety
The study was stopped early (reason given: inconclusive results, large inter-individual variation, insufficient statistical power). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2019.
- Individual participant dataSharing planned: No
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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.
Ulrik Wisløff, Professor study director
National Taiwan Normal University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High-intensity interval training and Moderate training in people with Healthy, run by Norwegian University of Science and Technology at 1 site in Norway.
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 3 inclusion and 9 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: stopped early, as of the sponsor's last update on 20 May 2019. 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 Norway. 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 was stopped early (reason given: inconclusive results, large inter-individual variation, insufficient statistical power). Results are not available in the source record.
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?
DNA-methylation (time frame: 8 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 20 May 2019.