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Comparison of the Effects of Different Upper Extremity Aerobic Exercise Training Protocols on Arm Functional Capacity in Patients With Heart Failure With Cardiac Implantable Electronic Devices

29 juli 2026 bijgewerkt door: Gamze Nur AHISKALI, Erol Olcok Corum Training and Research Hospital
  1. To determine the most suitable exercise protocol for upper extremity aerobic exercise training, a widely used type of aerobic exercise to improve reduced upper extremity functional capacity in individuals with CIED and HF.
  2. To investigate whether high-intensity intermittent upper extremity aerobic exercise training provides a more effective improvement in upper extremity functional capacity compared to moderate-intensity continuous upper extremity aerobic exercise training.
  3. To determine the effectiveness of different types of upper extremity aerobic exercise training compared to lower extremity aerobic training alone in individuals with CIED and HF.

Studie Overzicht

Toestand

Werving

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Geschat)

36

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Turkije (Türkiye)
      • Çorum, Turkije (Türkiye)
        • Werving
        • Hitit University Erol Olcok Training and Research Hospital, Cardiac Rehabilitation Unit
        • Contact:

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Beschrijving

Inclusion Criteria:

  • Patients aged 18 and over with heart failure who are receiving Implantable Cardioverter Defibrillator (ICD) or Cardiac Resynchronization Therapy (CRT)
  • At least 3 months have passed since device implantation and there have been no complications at the last device control
  • Being in New York Heart Association (NYHA) Class II-III
  • Patients without cooperation problems
  • Patients who volunteer to participate in the study

Exclusion Criteria:

  • Patients who have previously participated in a cardiac rehabilitation program and those who have completed less than 1 year since the program,
  • Patients with a primary diagnosis of cardiomyopathy and those with heart failure secondary to cardiomyopathy,
  • Patients with a history of shoulder pathologies that may restrict upper extremity movement before device implantation (such as severe pain around the shoulder, edema, or shoulder dislocation that restricts upper extremity movement),
  • Patients with a history of shoulder surgery (patients with limitations in range of motion),
  • Patients who have undergone mastectomy on the affected side or a cerebrovascular event resulting in arm involvement,
  • Patients with decompensated heart failure,
  • Patients with a history of ICD-incompatible shock,
  • Patients with a history of unstable angina pectoris, acute myocardial infarction, or cardiac surgery within the last 3 months,
  • Patients who have experienced acute atrial fibrillation, ventricular tachycardia, and ventricular fibrillation within the last 3 months,
  • Patients with actively treated malignancy or collagen tissue disease receiving systemic steroids
  • Patients with chronic kidney disease undergoing dialysis where volume load is unstable,
  • Persistent ventricular arrhythmias during baseline cardiopulmonary exercise testing.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Actieve vergelijker: Controlegroep
Ander: Lower Extremity Aerobic Exercise Training
a total of 40 minutes, at workloads equivalent to 70-80% of peak oxygen consumption
Experimenteel: High-Intensity Interval Group
Ander: High-Intensity Interval Upper Extremity Aerobic Exercise Training
total of 20 minutes, consisting of 5 minutes of warm-up, 3x2 minutes of high-intensity training at 80-90% of maximum workload, 2x2 minutes of active rest at 30-40% of maximum workload, and 5 minutes of cool-down
Ander: Lower Extremity Aerobic Exercise Training
a total of 40 minutes, at workloads equivalent to 70-80% of peak oxygen consumption
Experimenteel: Moderate Intensity Continuous Group
Ander: Lower Extremity Aerobic Exercise Training
a total of 40 minutes, at workloads equivalent to 70-80% of peak oxygen consumption
Ander: Moderate Intensity Continuous Upper Extremity Aerobic Exercise Training
a total of 20 minutes, consisting of 5 minutes of warm-up, 10 minutes at 70-80% of maximum workload, and 5 minutes of cool-down

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Maximal arm exercise capacity
Tijdsspanne: baseline and 8 weeks
The outcome will be evaluated using an arm ergometer exercise test. The test will begin with a 3-minute (unloaded) warm-up after rest. Different protocols will be applied to male and female patients due to differences in strength capabilities. Men will start rotating the ergometer with a 30-W workload, while women will start with a 20-W workload. In both protocols, patients will be asked to maintain a rotation speed of 70 revolutions per minute (rpm) throughout the test. Again, due to their different strength levels, the workload will be increased by 10W for men and 6W for women every minute.
baseline and 8 weeks
Functional arm exercise capacity
Tijdsspanne: baseline and 8 weeks
The outcome will be evaluated using the 6 Minute Pegboard and Ring Test (6PBRT). During the 6PBRT, participants are asked to move rings on a pegboard from the two lower holes to the two upper holes using both arms simultaneously for 6 minutes. Standardized encouragement is given every minute during the test. The number of rings moved over 6 minutes gives the total score of the test.
baseline and 8 weeks
Cardiorespiratory Fitness
Tijdsspanne: baseline and 8 weeks
The Maximum Symptom-Limited Cardiopulmonary Exercise Test (CPET), the gold standard method for assessing cardiorespiratory fitness, will be performed on a bicycle ergometer (Corival CPET, Lode, Groningen, Netherlands). During the test, the bicycle ergometer ramp test protocol will be applied (starting workload = 20 W / 20W increase every three minutes / maintaining a rotation speed of 60-70 rpm) (2). During the CPET, heart rate (HR) and heart rhythm will be continuously monitored with a 12-channel ECG test system (Custo Cardio 200 BT system, CustoMed GmbH, Ottoburn, Germany).
baseline and 8 weeks

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Peripheral muscle strength
Tijdsspanne: baseline and 8 weeks
The outcome will be measured using a hand dynamometer (Baseline Hydraulic Hand Dynamometer, Model: 12-0240, Fabrication Enterprises INC. White Plains, NY 10602 U.S.A.). Measurements will be taken in a seated position with shoulder adduction, elbow 90° flexion, and forearm in neutral position. Three repetitions will be performed for each side. The averages for the right and left sides will be recorded for statistical analysis.
baseline and 8 weeks
Activities of Daily Living
Tijdsspanne: baseline and 8 weeks
The outcome will be assessed using the Performance Measure for Activities of Daily Living-8 for Patients with Mild Symptomatic Heart Failure (PMADL-8). PMADL-8, an ICF-based scale, has a total score ranging from 8 to 32, and a high score indicates the level of limitation in activities of daily living.
baseline and 8 weeks
Health-related quality of life
Tijdsspanne: baseline and 8 weeks
MacNew Heart Disease Health-Related Quality of Life Questionnaire The questionnaire consists of three sub-dimensions and 27 items: a physical limitation scale, an emotional limitation scale, and a social functioning scale, with some items falling into more than one sub-dimension. Questions are scored between 1 and 7. The total score of the questionnaire is calculated by averaging the scores given to the sub-dimensions. Higher scores indicate better quality of life.
baseline and 8 weeks
Disease-related quality of life
Tijdsspanne: baseline and 8 weeks
Assessment of Quality of Life and Related Events Scale (AQUAREL) Developed specifically for patients with pacemakers, the scale consists of 5 main sections: chest pain, arrhythmia, dyspnea, exertion, and cognition. The scale consists of 24 questions scored using a 5-point Likert system. The total score ranges from 0 to 100. A low score reflects a perception of poor health, loss of function, and the presence of pain, while a high score reflects a perception of good health, preserved function, and the absence of pain.
baseline and 8 weeks

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Erol Olcok Corum Training and Research Hospital

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

11 mei 2026

Primaire voltooiing (Geschat)

11 mei 2027

Studie voltooiing (Geschat)

11 mei 2027

Studieregistratiedata

Eerst ingediend

5 mei 2026

Eerst ingediend dat voldeed aan de QC-criteria

11 mei 2026

Eerst geplaatst (Werkelijk)

18 mei 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

31 juli 2026

Laatste update ingediend die voldeed aan QC-criteria

29 juli 2026

Laatst geverifieerd

1 mei 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 2026-02

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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