Clinical trial NCT04803968: The Effect of Combined Upper and Lower Extremity Endurance Training in Patients With ICD
Official title: The Effect of Upper Extremity Endurance Training Applied in Addition to Lower Extremity Endurance Training on Functional Capacity and Pacemaker Functions in Heart Failure Patients With Implantable Cardioverter Defibrillator (ICD)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Heart Failure With Reduced Ejection Fraction
Keywords: Implantable cardiac defibrillator
Upper extremity endurance training
peak Oxygen consumption
upper extremity functional capacity
Lead sponsor: Hitit University
Sponsor class: OTHER
Collaborators: name: Hacettepe University
First posted: 2021-03-18
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized controlled clinical trial
Primary purpose: TREATMENT

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 failure patients with ICD.

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 when the pulse decreases can be implanted. At the same time, pacemakers can be implanted in VR-ICD, DR-ICD modes, which have the ability to recognize fatal rhythm problems such as Ventricular tachycardia (VT) / Ventricular Fibrillation (VF) and perform intracardiac defibrillation (ICD).

Pacemakers are positioned by opening a pocket under the patient's left pectoral muscle.Cables coming out of the battery (leads) are placed in the right ventricle, right atrium or coronary sinuses via active or passive fixation through the left subclavian vein. In the early period after pacemaker implantation, patients are warned to avoid movements that force the extremity on that side so that the leads and battery are affected by extremity movements and their positions and functions are not impaired.

Many pacemaker patients prolong this period too much (\> 3 months), causing them to develop left extremity muscle-joint dysfunction. This situation can also affect the functional capacity of the patients.ICD pacemakers are larger in size than conventional pacemakers due to their functions, so they are placed in a larger pocket in the pectoral area.These patients are warned more strictly about coercive movements.

The aim of this study is to investigate the effect of arm ergometer endurance training on functional capacity and upper extremity function in heart failure patients with ICD included in cardiac rehabilitation program, and to examine the effect on battery and leads as safety parameters.

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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.

Primary outcomes:
measure: Cardiorespiratory functional capacity
timeFrame: Through study completion, an average of 1 year
measure: Arm ergometer endurance capacity
timeFrame: Through study completion, an average of 1 year
measure: 6 minute pegboard and ring test
timeFrame: Through study completion, an average of 1 year
measure: Handgrip
timeFrame: Through study completion, an average of 1 year
Secondary outcomes:
measure: Quick DASH
timeFrame: Through study completion, an average of 1 year
measure: The Minnesota Living with Heart Failure Questionnaire (MLHFQ)
timeFrame: Through study completion, an average of 1 year
measure: General Practice Physical Activity Questionnaire (GPPAQ)
timeFrame: Through study completion, an average of 1 year
Other outcomes:
Locations:
city: Çorum
country: Turkey
facility: Hitit University
Study officials:
References: