CClinicalTrials.gg
TerminatedNCT01931072Updated May 20, 2019

Exercise-induced Changes in DNA-methylation

An interventional study of High-intensity interval training and Moderate training in Healthy, sponsored by Norwegian University of Science and Technology. Terminated at 1 site in Norway. Open to male participants aged 70 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-05-20.

Sponsored by Norwegian University of Science and Technology · Not applicable, Interventional, and Basic science

Why this study was terminated
inconclusive results, large inter-individual variation, insufficient statistical power

From the registry’s dates

  • Registered 1 year after the study started (first participant enrolled Aug 2012, registered Aug 2013).
Phase
Not applicable
Study type
Interventional
Enrollment
37
Allocation
Randomized
Ages
70 Years to 75 Years
Sex
Male
01

Study 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. 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.

02

Conditions studied

  • Healthy

Keywords

  • Exercise
  • High-intensity interval training
  • Moderate training
  • Healthy elderly
  • Skeletal muscle
  • DNA-methylation
  • Gene expression
  • subjects
03

In context

Lead sponsor

Norwegian University of Science and Technology is the lead sponsor of 487 studies on the registry; 52 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
70 Years to 75 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Inclusion criteria

  • Male
  • 70-75 years old
  • Signed written informed consent

Exclusion criteria

Exclusion Criteria:

  • Incompatible with exercise
  • Known cardiac disease
  • Active cancer
  • Significant pulmonary disease
  • Uncontrolled hypertension
  • Use of blood thinning medicine (except Albyl-E)
  • Drug abuse
  • Alcohol abuse
  • Finishing less than 80% of the exercise sessions (this complies to the training groups)
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Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
37 participants (actual)

Study arms

  • Experimental
    High-intensity interval training

    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.

    Behavioral: High-intensity interval training

  • Active comparator
    Moderate training

    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.

    Behavioral: Moderate training

  • No intervention
    Control

    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.

Interventions

  • BehavioralHigh-intensity interval training

    Interval training 3 times a week for 8 weeks

  • BehavioralModerate training

    Moderate training 3 times a week for 8 weeks

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 8 weeks

  2. Gene Expression

    Time frame: 8 weeks

Secondary outcomes

  1. Maximal Aerobic Capacity

    measured on treadmill at baseline and after eight weeks, also biopsies from Vastus lateralis were sampled.

    Time frame: 8 weeks

07

Study locations

1 site
  • Institute for Circulation and Medical Imaging, NTNU
    Trondheim, Norway
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 20, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01931072
Lead sponsor
Norwegian University of Science and Technology
Collaborators
St. Olavs Hospital
Responsible party
Sponsor
First posted
Aug 29, 2013
Start date
Aug 2012
Primary completion
Dec 2012
Completion
Dec 2013
Last update
May 20, 2019

Study contacts

Ulrik Wisløff, Professor
study director · National Taiwan Normal University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is terminated, as verified in May 2019. You cannot join it, but the record below documents what was studied.

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