NCT01673958

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2012

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

February 1, 2012

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2012

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

August 22, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 28, 2012

Completed
Last Updated

August 28, 2012

Status Verified

August 1, 2012

Enrollment Period

2 months

First QC Date

August 22, 2012

Last Update Submit

August 24, 2012

Conditions

Keywords

Eccentric exerciseAgingHeart failureMuscle strength lossSarcopenia

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (3)

  • Pain free range of motion (degrees)

    Before and at day 2 post exercise at the first and sixth week of training

  • Creatine kinase, CK (activity IU)

    Before and at day 2 post exercise at the first and sixth week of training

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

    Before and at day 2 post exercise at the first and sixth week of training

Study Arms (2)

Stair descending group

EXPERIMENTAL

Stair descending exercise. Participants will carry out six weeks of stair descending training consisting of three exercise sessions per week.

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.

Other: Exercise

Interventions

Comparison between stair descending and stair ascending training

Stair ascending groupStair descending group

Eligibility Criteria

Age60 Years - 70 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • chronic heart failure (New York Heart Association class I-II)
  • subject provides written informed consent
  • personal physician of the participants provides written informed consent

You may not qualify if:

  • smoker
  • consumed any nutritional supplement the last 3 months
  • performed intense eccentric exercise the last 6 months
  • non Caucasian

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

European University Cyprus

Nicosia, 1516, Cyprus

Location

Related 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.

    PMID: 20508540BACKGROUND

MeSH Terms

Conditions

Heart FailureSarcopenia

Interventions

Exercise

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesMuscular AtrophyNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsSigns and Symptoms

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • George Panayiotou, PhD

    Research Centre, European University Cyprus

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

August 22, 2012

First Posted

August 28, 2012

Study Start

February 1, 2012

Primary Completion

April 1, 2012

Study Completion

April 1, 2012

Last Updated

August 28, 2012

Record last verified: 2012-08

Locations