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Cardiac Rehabilitation for Patients Receiving Radiation Therapy for Thoracic Cancers

A legfontosabb adatok

Ki végzi
Washington University School of Medicine
Hol
St Louis (Egyesült Államok)A helyszín megnézése
Azonosító
Állapot
Leállítva
Résztvevők
24 fő vett részt
Kezdés
2021. jan. 15.
Befejezés
2024. máj. 15.
A vizsgálat típusa
Beavatkozással járó
A vizsgált kezelések
  • Home-based cardiac rehabilitation
A regiszteradat frissítve
2024. július 12.
Miért állt le
Futility

Ki vehet részt

Életkor
18 év felett
Nem
Nők és férfiak
Egészséges önkéntesek
Nem vehetnek részt

A regiszter feltételei, szó szerint

Mind a 20 feltétel megnézéseKevesebb

Ki vehet részt

  • Pathologically confirmed or radiographically diagnosed non-small cell lung cancer, small cell lung cancer, esophageal cancer, Hodgkin lymphoma, non-Hodgkin lymphoma, sarcoma, thymoma, or left-sided breast cancer
  • Planning to receive neo-adjuvant, adjuvant, or definitive radiation therapy to the thorax with curative intent
  • Willing to participate in home-based cardiac rehabilitation program and be monitored remotely via smart phone application
  • Possess a smart phone or tablet capable of supporting teleHeart application
  • Willing and eligible to co-enroll in the Cardiovascular Toxicity in Cancer and Improvement in Recovery (SURVIVE) Registry Study (HRPO# 201801031)
  • At least 18 years of age
  • ECOG performance status ≤ 2
  • Ability to understand and willingness to sign an IRB approved written informed consent document (or that of legally authorized representative, if applicable)

Ki nem vehet részt

  • Presence of distant metastatic disease (except patients with lymphoma)
  • Presence of significant cancer disease burden that would make patient unlikely to tolerate cardiac rehabilitation (CR)
  • Diagnosis of primary cervical esophageal cancer
  • Presence of unstable angina
  • Recipient of heart transplant
  • Patient on cardiac transplant list or has a ventricular assist device
  • Life expectancy less than 6 months
  • Patient lives in skilled nursing facility, chronic care facility, nursing home, or palliative care or hospice facility
  • Unable to walk
  • Patient's baseline weight > 300 lbs (due to weight limitations of the scale and bioelectrical impedance device)
  • Pregnant and/or breastfeeding. Women of childbearing potential must have a negative pregnancy test within 14 days of study entry
  • Other medical comorbidities that make the patient unable to participate in the CR program or other assessments involved with this study

Helyszínek itt: Egyesült Államok

  • Washington University School of MedicineSt Louis, Egyesült Államok

A vizsgálatról

Mit akar kideríteni a vizsgálat

Other than optimizing medical management of cardiac risk factors, and reducing radiotherapy (RT) dose to the heart, there currently exist no interventions to mitigate or reverse the adverse cardiac effects of RT. Aerobic exercise has been demonstrated to improve patient quality of life, cardiac outcomes, and cardiorespiratory fitness in patients with cancer receiving cardiotoxic systemic therapies, but the effects of aerobic exercise on patients at high risk for radiation induced heart disease (RIHD) is unknown. In addition, home-based cardiac rehabilitation has not been tested in patients with thoracic cancers.

A vizsgálat csoportja

  • Home-based cardiac rehabilitationA vizsgált kezelés

    * The intervention consists of a prescribed course of home-based cardiac rehabilitation: 36 sessions, three times a week, one hour each, over a period of 12 weeks. * Each customized exercise session includes three phases: * a 5- to 10-minute warm-up which consists of stretching, flexibility movements, and aerobic activity which gradually raises the heart rate to the desired level * a conditioning or training phase, which consists of 20 to 45 minutes of continuous or discontinuous aerobic activity * a cool down for 5 to 10 minutes consisting of low-intensity exercise that permits a gradual recovery from the conditioning phase * The patient will complete a brief questionnaire on the teleHeart application after completing each exercise session on how well they tolerated the exercise. The patient's CR team will receive daily updates from the patient's teleHeart application. Based on feedback from the application, the CR team may modify the patient's exercise program going forward.

Adatok és források

Regiszteradat
Szerepel a ClinicalTrials.gov-on.
Hivatalos cím
A Pilot Trial of Cardiac Rehabilitation for Patients Receiving Radiation Therapy for Thoracic Cancers
A regiszteradat frissítve
2024. július 12.