NCT01931072

Brief 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.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
37

participants targeted

Target at P25-P50 for not_applicable healthy

Timeline
Completed

Started Aug 2012

Typical duration for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
terminated

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

August 1, 2012

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

August 26, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 29, 2013

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

May 20, 2019

Status Verified

May 1, 2019

Enrollment Period

4 months

First QC Date

August 26, 2013

Last Update Submit

May 16, 2019

Conditions

Healthy

Keywords

ExerciseHigh-intensity interval trainingModerate trainingHealthy elderlySkeletal muscleDNA-methylationGene expressionsubjects

Outcome Measures

Primary Outcomes (2)

  • 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.

    8 weeks

  • Gene Expression

    8 weeks

Secondary Outcomes (1)

  • Maximal Aerobic Capacity

    8 weeks

Study Arms (3)

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.

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.

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.

Interventions

High-intensity interval trainingBEHAVIORAL

Interval training 3 times a week for 8 weeks

High-intensity interval training
Moderate trainingBEHAVIORAL

Moderate training 3 times a week for 8 weeks

Moderate training

Eligibility Criteria

Age70 Years - 75 Years
Sexmale
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • Male
  • years old
  • Signed written informed consent

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute for Circulation and Medical Imaging, NTNU

Trondheim, Norway

Location

MeSH Terms

Conditions

Motor Activity

Interventions

High-Intensity Interval Training

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Physical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Ulrik Wisløff, Professor

    National Taiwan Normal University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 26, 2013

First Posted

August 29, 2013

Study Start

August 1, 2012

Primary Completion

December 1, 2012

Study Completion

December 1, 2013

Last Updated

May 20, 2019

Record last verified: 2019-05

Data Sharing

IPD Sharing
Will not share

Locations

NO(1)