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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 oppdatert av: 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.

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Antatt)

36

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Tyrkia (Türkiye)
      • Çorum, Tyrkia (Türkiye)
        • Rekruttering
        • Hitit University Erol Olcok Training and Research Hospital, Cardiac Rehabilitation Unit
        • Ta kontakt med:

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Aktiv komparator: Kontrollgruppe
Annen: Lower Extremity Aerobic Exercise Training
a total of 40 minutes, at workloads equivalent to 70-80% of peak oxygen consumption
Eksperimentell: High-Intensity Interval Group
Annen: 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
Annen: Lower Extremity Aerobic Exercise Training
a total of 40 minutes, at workloads equivalent to 70-80% of peak oxygen consumption
Eksperimentell: Moderate Intensity Continuous Group
Annen: Lower Extremity Aerobic Exercise Training
a total of 40 minutes, at workloads equivalent to 70-80% of peak oxygen consumption
Annen: 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

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Maximal arm exercise capacity
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Peripheral muscle strength
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Erol Olcok Corum Training and Research Hospital

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

11. mai 2026

Primær fullføring (Antatt)

11. mai 2027

Studiet fullført (Antatt)

11. mai 2027

Datoer for studieregistrering

Først innsendt

5. mai 2026

Først innsendt som oppfylte QC-kriteriene

11. mai 2026

Først lagt ut (Faktiske)

18. mai 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

31. juli 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

29. juli 2026

Sist bekreftet

1. mai 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 2026-02

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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