Status:

UNKNOWN

The Effect of Combined Upper and Lower Extremity Endurance Training in Patients With ICD

Lead Sponsor:

Hitit University

Collaborating Sponsors:

Hacettepe University

Conditions:

Heart Failure With Reduced Ejection Fraction

Eligibility:

All Genders

18-80 years

Phase:

NA

Brief Summary

It was aimed to examine whether the arm endurance exercise training is effective in addition to the lower cycling training program in order to alleviate the negative functional results in heart failur...

Detailed Description

Pacemaker (permanent battery) is implanted in patients for many reasons. For reasons such as symptomatic bradycardia and AV block, a pacemaker with modes such as VVR and DDDR designed for pacing only ...

Eligibility Criteria

Inclusion

  • Patients with a diagnosis of heart failure in the New York Heart Association (NYHA) class II-III, who have had at least 3 months past ICD implantation, and who did not have any complications at the last pacemaker control,
  • Ejection fraction (EF) value ≤45%,
  • The medicines used have not been changed for at least 3 months,
  • Volunteering to participate in the research, being able to attend a 1-hour rehabilitation program every day of the week,
  • To be clinically stable, to be under control if any accompanying comorbid conditions (such as hypertension, diabetes),
  • Not having any orthopedic problems that may prevent him from exercising with his bicycle and arm ergometer,
  • CPET, ambulatory blood pressure and rhythm monitoring, ECG and ECHO without any obstacle to exercise within the framework of TKD cardiology guidelines (such as moderate valve disease, hypertrophic cardiomyopathy, severe uncontrolled HT…).

Exclusion

  • Those with a history of shoulder injury (severe pain around the shoulder and inability to move, severe swelling around the shoulder, shoulder dislocation)
  • Those with a history of shoulder surgery,
  • Sequelae of a cerebrovascular accident with mastectomy or arm involvement on the affected side,
  • Having decompensated heart failure,
  • Having an obstacle to exercise within the framework of TSC (Turkish Society of Cardiology) cardiology guidelines in CPET, ambulatory blood pressure and rhythm monitoring, ECG and ECO (such as moderate valve disease, hypertrophic cardiomyopathy, severe uncontrolled HT ...)
  • Having a history of ICD shock in the last 6 months,
  • Having an active treated malignancy or a collagen tissue disease receiving systemic steroids
  • Being unable to cooperate or adapt to exercise due to cerebrovascular disease or other reasons,
  • Having a chronic kidney disease undergoing dialysis where the volume load is not stable.

Key Trial Info

Start Date :

January 1 2021

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

January 1 2022

Estimated Enrollment :

45 Patients enrolled

Trial Details

Trial ID

NCT04803968

Start Date

January 1 2021

End Date

January 1 2022

Last Update

April 1 2021

Active Locations (1)

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1

Hitit University

Çorum, Turkey (Türkiye), 19030

The Effect of Combined Upper and Lower Extremity Endurance Training in Patients With ICD | DecenTrialz