AgingNCT01673958
Stair Descending vs. Stair Ascending Exercise
A study testing Exercise in people with Aging and Heart Failure, run by European University Cyprus at 1 site in Cyprus.
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. Read more about this study
- Who is it for?
- Ages 60 to 70 years, men only
- Conditions the study is for
- Aging, Heart Failure, Sarcopenia
- What is being tested?
- Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteCyprus
- Study dates
- Feb 2012to Apr 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 60 to 70 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- chronic heart failure (New York Heart Association class I-II)
- subject provides written informed consent
- personal physician of the participants provides written informed consent
Who cannot join
- smoker
- 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.
About this study
Official title: The Effect of Stair Descending and Stair Ascending Exercise on Muscle Strength and Performance: the SmartEscalator Device
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.
Read the 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.
- Conditions
- Aging, Heart Failure, Sarcopenia
- Being tested
- Exercise
- Keywords
- Eccentric exercise, Aging, Heart failure, Muscle strength loss, Sarcopenia
- Medical subject headings
- Heart Failure, Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
Comparison between stair descending and stair ascending training
| Study group | Role | What they receive |
|---|---|---|
| Stair descending group | Experimental | Stair descending exercise. Participants will carry out six weeks of stair descending training consisting of three exercise sessions per week. Receives: Other: Exercise |
| Stair ascending group | Experimental | Stair ascending exercise. Participants will carry out six weeks of stair descending training consisting of three exercise sessions per week. Receives: Other: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change from baseline in muscle strength at day 2 post exercise at the first and sixth week of training
Secondary outcomes (3)
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.
Measured: Before and at day 2 post exercise at the first and sixth week of training
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.
Measured: Before and at day 2 post exercise at the first and sixth week of training
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).
Measured: Before and at day 2 post exercise at the first and sixth week of training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2012 (estimated)
- Study startFeb 2012
- Primary completionApr 2012
- Study completionApr 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AgingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- European University Cyprus
- Sponsor type
- University, hospital or other
- Collaborators
- University of Thessaly, Aristotle University Of Thessaloniki
- Responsible party
- Principal investigator, Dr. Anastasios Theodorou, European University Cyprus
- Investigators
- George Panayiotou, PhD, Study chair, Research Centre, European University Cyprus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01673958
- Sponsor's protocol ID
- EUC-011
- Status last verified
- Aug 2012
- First submitted
- 22 Aug 2012
- Last updated
- 28 Aug 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 20508540
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Stair Descending and Stair Ascending Exercise on Muscle Strength and Performance: the SmartEscalator Device
- ClinicalTrials.gov ID
- NCT01673958
- Acronym / sponsor ID
- EUC-011
- Conditions
- Aging, Heart Failure, Sarcopenia
- Keywords
- Eccentric exercise, Aging, Heart failure, Muscle strength loss, Sarcopenia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- European University CyprusUniversity, hospital or other
- Collaborators
- University of Thessaly, Aristotle University Of Thessaloniki
- Study start
- Feb 2012
- Primary completion
- Apr 2012 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 28 Aug 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stair descending group | Experimental | Other: ExerciseStair descending exercise. Participants will carry out six weeks of stair descending training consisting of three exercise sessions per week. |
| Stair ascending group | Experimental | Other: ExerciseStair ascending exercise. Participants will carry out six weeks of stair descending training consisting of three exercise sessions per week. |
Who may qualify
- Ages
- 60 to 70 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- chronic heart failure (New York Heart Association class I-II)
- subject provides written informed consent
- personal physician of the participants provides written informed consent
Key exclusion criteria (4 listed)
- smoker
- consumed any nutritional supplement the last 3 months
- performed intense eccentric exercise the last 6 months
- non Caucasian
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExerciseComparison between stair descending and stair ascending training | Other | Stair ascending group, Stair descending group |
Primary outcome
Muscle strength (torque)
Time frame: Change from baseline in muscle strength at day 2 post exercise at the first and sixth week of training
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.
3 secondary outcomes
Pain free range of motion (degrees)
Time frame: Before and at day 2 post exercise at the first and sixth week of training
Creatine kinase, CK (activity IU)
Time frame: Before and at day 2 post exercise at the first and sixth week of training
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2012.
- Background: PubMed 20508540Paschalis 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
George Panayiotou, PhD study chair
Research Centre, European University Cyprus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with Aging and Heart Failure, 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 4 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 28 Aug 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 strength (torque) (time frame: Change from baseline in muscle strength at day 2 post exercise at the first and sixth week of training). 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 NCT01673958, which also lists 1 linked publication.
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 28 Aug 2012.