- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01673958
Stair Descending vs. Stair Ascending Exercise
The Effect of Stair Descending and Stair Ascending Exercise on Muscle Strength and Performance: the SmartEscalator Device
Study Overview
Detailed 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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Nicosia, Cyprus, 1516
- European University Cyprus
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Stair descending group
Stair descending exercise.
Participants will carry out six weeks of stair descending training consisting of three exercise sessions per week.
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Comparison between stair descending and stair ascending training
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Experimental: Stair ascending group
Stair ascending exercise.
Participants will carry out six weeks of stair descending training consisting of three exercise sessions per week.
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Comparison between stair descending and stair ascending training
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Muscle strength (torque)
Time Frame: Change from baseline in muscle strength at day 2 post exercise at the first and sixth week of training
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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.
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Change from baseline in muscle strength at day 2 post exercise at the first and sixth week of training
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pain free range of motion (degrees)
Time Frame: Before and at day 2 post exercise at the first and sixth week of training
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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.
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Before and at day 2 post exercise at the first and sixth week of training
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Creatine kinase, CK (activity IU)
Time Frame: Before and at day 2 post exercise at the first and sixth week of training
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CK activity will be measured as a general indicator of muscle damage.It will be measured in a Cobas Integra Plus 400 chemistry analyzer.
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Before and at day 2 post exercise at the first and sixth week of training
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Delayed onset muscle soreness, DOMS (scale 1-10)
Time Frame: Before and at day 2 post exercise at the first and sixth week of training
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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).
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Before and at day 2 post exercise at the first and sixth week of training
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Collaborators and Investigators
Sponsor
Investigators
- Study Chair: George Panayiotou, PhD, Research Centre, European University Cyprus
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- EUC-011
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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