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AgingNCT01728675

Eccentric Exercise and Oxidative Stress

A study testing Exercise in people with Aging and Muscle Damage, run by European University Cyprus at 1 site in Cyprus.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of the present investigation is to compare the responses and adaptations of young and elderly individuals to repeated eccentric exercise in regards to muscle function and redox homeostasis in a side-by-side comparison. Read more about this study

Who is it for?
Ages 18 to 70 years, men onlyHealthy volunteers can take part
Conditions the study is for
Aging, Muscle Damage, Oxidative Stress
What is being tested?
Exercise
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteCyprus
Study dates
May 2012to Jul 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 18 to 70 years
  • Men only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • subject provides written informed consent
  • physiological health profile
  • stable at their anthropometric characteristics for at least the last year

Who cannot join

  • muscle disease
  • prior history of musculoskeletal injury to the lower limbs
  • smokers
  • consumed any nutritional supplement the last 3 months
  • performed intense eccentric exercise the last 6 months
  • non Caucasian

Trial locations and contacts

1 site in 1 country.

Cyprus1 site

  • European University Cyprus

    Nicosia, 1516

Other trials in Cyprus

About this study

Official title: The Effect of Eccentric Exercise on Oxidative Stress in the Elderly

The purpose of the present investigation is to compare the responses and adaptations of young and elderly individuals to repeated eccentric exercise in regards to muscle function and redox homeostasis in a side-by-side comparison.

Read the detailed description

Despite the progress of analytic techniques and the refinement of study designs, striking disagreement exists among studies regarding the influence of exercise on muscle function and redox homeostasis in the elderly. A specific exercise protocol will be applied (the repeated eccentric model) to produce long-lasting and extensive changes in redox biomarkers and to examine more easily the potential effects of aging. Ten young men and ten elderly men will underwent an isokinetic eccentric exercise session, which will be repeated after three weeks. Muscle function indices and redox biomarkers will be assessed in urine, plasma or erythrocytes pre exercise, immediately post exercise, 2 and 4 days post exercise.

Being tested
Exercise
Keywords
Aging, Skeletal muscle, Biomarkers, Adaptation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ExerciseOther

    Participants will perform two isokinetic eccentric exercise bouts

Study groups in NCT01728675
Study groupRoleWhat they receive
Young groupExperimentalParticipants will underwent two isokinetic eccentric exercise sessions
Receives: Other: Exercise
Elderly groupExperimentalParticipants will underwent two isokinetic eccentric exercise sessions
Receives: Other: Exercise

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Muscle torque (torque)

    Measured: Change in muscle torque from baseline (pre-exercise) at immediately after exercise and at day 2 and day 4 post-exercise

  2. Range of motion, ROM (degrees)

    Measured: Change in ROM from baseline (pre-exercise) at immediately after exercise and at day 2 and day 4 post-exercise

  3. Delayed onset muscle soreness, DOMS (scale 1-10)

    Measured: Change in DOMS from baseline (pre-exercise) at immediately after exercise and at day 2 and day 4 post-exercise

  4. Creatine kinase, CK (activity IU)

    Measured: Change in CK from baseline (pre-exercise) at immediately after exercise and at day 2 and day 4 post-exercise

Secondary outcomes (10)

  1. F2-isoprostanes (pg/mg creatinine)

    Measured: Change in F2-isoprostanes from baseline (pre-exercise) at immediately after exercise and at day 2 and day 4 post-exercise

  2. Protein carbonyls (nmol/mg protein)

    Measured: Change in F2-isoprostanes from baseline (pre-exercise) at immediately after exercise and at day 2 and day 4 post-exercise

  3. Glutathione, GSH (μmol/g Hb)

    Measured: Change in GSH from baseline (pre-exercise) at immediately after exercise and at day 2 and day 4 post-exercise

  4. Catalase (U/g Hb)

    Measured: Change in catalase from baseline (pre-exercise) at immediately after exercise and at day 2 and day 4 post-exercise

  5. Superoxide dismutase, SOD (U/g Hb)

    Measured: Change in SOD from baseline (pre-exercise) at immediately after exercise and at day 2 and day 4 post-exercise

  6. Glutathione peroxidase, GPx (U/g Hb)

    Measured: Change in GPx from baseline (pre-exercise) at immediately after exercise and at day 2 and day 4 post-exercise

  7. Glucose-6-phosphate dehydrogenase, G6PD (U/g Hb)

    Measured: Change in G6PD from baseline (pre-exercise) at immediately after exercise and at day 2 and day 4 post-exercise

  8. Uric acid (mM)

    Measured: Change in uric acid from baseline (pre-exercise) at immediately after exercise and at day 2 and day 4 post-exercise

  9. Albumin (μM)

    Measured: Change in albumin from baseline (pre-exercise) at immediately after exercise and at day 2 and day 4 post-exercise

  10. Bilirubin (μM)

    Measured: Change in bilirubin from baseline (pre-exercise) at immediately after exercise and at day 2 and day 4 post-exercise

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Nov 2012 (estimated)
  2. Study startMay 2012
  3. Primary completionJul 2012
  4. Study completionJul 2012

Resources

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
Supportive care
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01728675
Sponsor's protocol ID
EUC-017
Other IDs
EUC-019
Status last verified
Nov 2012
First submitted
6 Nov 2012
Last updated
20 Nov 2012
Results posted
No
Data monitoring committee
No

Publications

  • Nikolaidis MG, Kyparos A, Vrabas IS. F(2)-isoprostane formation, measurement and interpretation: the role of exercise. Prog Lipid Res. 2011 Jan;50(1):89-103. doi: 10.1016/j.plipres.2010.10.002. Epub 2010 Oct 15.

    PubMed 20951733

  • Nikolaidis MG, Jamurtas AZ. Blood as a reactive species generator and redox status regulator during exercise. Arch Biochem Biophys. 2009 Oct 15;490(2):77-84. doi: 10.1016/j.abb.2009.08.015. Epub 2009 Aug 25.

    PubMed 19712664

  • Nikolaidis MG, Kyparos A, Spanou C, Paschalis V, Theodorou AA, Vrabas IS. Redox biology of exercise: an integrative and comparative consideration of some overlooked issues. J Exp Biol. 2012 May 15;215(Pt 10):1615-25. doi: 10.1242/jeb.067470.

    PubMed 22539728

  • Theodorou AA, Nikolaidis MG, Paschalis V, Sakellariou GK, Fatouros IG, Koutedakis Y, Jamurtas AZ. Comparison between glucose-6-phosphate dehydrogenase-deficient and normal individuals after eccentric exercise. Med Sci Sports Exerc. 2010 Jun;42(6):1113-21. doi: 10.1249/MSS.0b013e3181c67ecd.

    PubMed 19997026

  • Panayiotou G, Paschalis V, Nikolaidis MG, Theodorou AA, Deli CK, Fotopoulou N, Fatouros IG, Koutedakis Y, Sampanis M, Jamurtas AZ. No adverse effects of statins on muscle function and health-related parameters in the elderly: an exercise study. Scand J Med Sci Sports. 2013 Oct;23(5):556-67. doi: 10.1111/j.1600-0838.2011.01437.x. Epub 2012 Jan 31.

    PubMed 22288788

Questions about this trial

What is this clinical trial studying?

A study testing Exercise in people with Aging and Muscle Damage, run by European University Cyprus at 1 site in Cyprus.

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 6 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 20 Nov 2012. 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 Cyprus. 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?

Muscle torque (torque) (time frame: Change in muscle torque from baseline (pre-exercise) at immediately after exercise and at day 2 and day 4 post-exercise). The study lists 4 primary outcomes in all. 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 NCT01728675, which also lists 5 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 20 Nov 2012.

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