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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01673958
Other study ID # EUC-011
Secondary ID
Status Completed
Phase N/A
First received August 22, 2012
Last updated August 24, 2012
Start date February 2012
Est. completion date April 2012

Study information

Verified date August 2012
Source European University Cyprus
Contact n/a
Is FDA regulated No
Health authority Cyprus: Ministry of Health
Study type Interventional

Clinical Trial Summary

The aim of the present project is to compare the acute and chronic effect of stair descending versus stair ascending exercise on muscle damage and performance in elderly males with chronic heart failure.


Description:

Study design:

Twelve elderly males with chronic heart failure, New York Heart Association class I-II, will participate in this study. Participants will be allocated into two equally-sized groups: a stair descending group (n = 6) and a stair ascending group (n = 6). At the beginning of the study, the volunteers will perform an acute bout of stair descending or stair ascending exercise on an automatic escalator (4 sets of 3 min each, speed will be set at 45 steps∙min-1). Step height will be 20.5 mm. Before and at day 2 post exercise, physiologic measurements will be performed and blood samples will be collected. Then, participants will carry out six weeks of stair descending or ascending training consisting of three exercise sessions per week (the first two weeks the speed will be set at 45 steps∙min-1, the next two weeks at 50 steps∙min-1 and the last two weeks at 55 steps∙min-1 for both groups). Afterward, they will repeat the acute stair descending or ascending protocol, as carried out at the beginning of the study, and the same physiologic measurements will be performed and blood samples will be collected.

Measurements:

Isometric (at 90 knee flexion), concentric and eccentric peak torque at 60o∙s-1of quadriceps femoris, pain-free range of motion, delayed onset muscle soreness and creatine kinase will be measured.


Recruitment information / eligibility

Status Completed
Enrollment 12
Est. completion date April 2012
Est. primary completion date April 2012
Accepts healthy volunteers No
Gender Male
Age group 60 Years to 70 Years
Eligibility Inclusion Criteria:

- chronic heart failure (New York Heart Association class I-II)

- subject provides written informed consent

- personal physician of the participants provides written informed consent

Exclusion Criteria:

- smoker

- consumed any nutritional supplement the last 3 months

- performed intense eccentric exercise the last 6 months

- non Caucasian

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Other:
Exercise
Comparison between stair descending and stair ascending training

Locations

Country Name City State
Cyprus European University Cyprus Nicosia

Sponsors (3)

Lead Sponsor Collaborator
European University Cyprus Aristotle University Of Thessaloniki, University of Thessaly

Country where clinical trial is conducted

Cyprus, 

References & Publications (1)

Paschalis V, Nikolaidis MG, Theodorou AA, Panayiotou G, Fatouros IG, Koutedakis Y, Jamurtas AZ. A weekly bout of eccentric exercise is sufficient to induce health-promoting effects. Med Sci Sports Exerc. 2011 Jan;43(1):64-73. doi: 10.1249/MSS.0b013e3181e91d90. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Muscle strength (torque) An isokinetic dynamometer (Cybex, Ronkonkoma, NY) will be used for the measurement of isometric, eccentric and concentric knee extensor peak torque at 90° knee flexion. The average of the three best maximal voluntary contractions with their dominant leg will be recorded. In order to ensure that the subjects provide their maximal effort, the measurements will be repeated if the difference between the lower and the higher torque value exceeded 10%. There will be two minutes rest between isometric efforts. Change from baseline in muscle strength at day 2 post exercise at the first and sixth week of training No
Secondary Pain free range of motion (degrees) The assessment of pain-free ROM will be performed manually using the the isokinetic dynamometer. The investigator will move the calf at a very low angular velocity from 0 knee extension to the position where the subject will feel any discomfort. Before and at day 2 post exercise at the first and sixth week of training No
Secondary Creatine kinase, CK (activity IU) CK activity will be measured as a general indicator of muscle damage.It will be measured in a Cobas Integra Plus 400 chemistry analyzer. Before and at day 2 post exercise at the first and sixth week of training No
Secondary Delayed onset muscle soreness, DOMS (scale 1-10) Each participant will assess delayed onset muscle soreness (DOMS) during squat movement (90o knee flexion) and perceived soreness will be rated on a scale ranging from 1 (normal) to 10 (very sore). Before and at day 2 post exercise at the first and sixth week of training No
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