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A remote-CORE study

A pilot clinical study confirming the safety of a remote cardio-oncology rehabilitation (CORE) intervention for cancer patients.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT1031240297
Enrollment
10
Registered
2024-08-26
Start date
2024-08-26
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Malignant Lymphoma, cancer therapy-related cardiac dysfunction, heart failure

Interventions

Intervention by Rehabilitation: Perform ergometer exercise at an intensity level one minute before the anaerobic threshold (AT) obtained from cardiopulmonary exercise testing (CPX) for 20-40 minutes p

Sponsors

Shiga Taro
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1: Males and females aged 18 years or older at the time of consent. 2: If the attending hematologist, cardiologist, rehabilitation specialist, and principal investigator of this study determine that rehabilitation intervention is possible. 3: Patients receiving induction chemotherapy including anthracyclines at the Hematology-Oncology Department of Cancer Institute Hospital Ariake. 4: Patients who receive rehabilitation guidance from the Rehabilitation Department of Cancer Institute Hospital Ariake during hospitalization for initial induction chemotherapy. 5: Patients who can communicate via the internet at home or elsewhere after discharge. 6: Patients who have received a thorough explanation of this study and have given consent of their own free will.

Exclusion criteria

Exclusion criteria: 1: Weight of 130 kg or more at the time of consent. 2: Concerns about mental illness or cognitive impairment. 3: Terminal stage. 4: Living alone or in other situations where adequate supervision cannot be ensured, making it difficult to guarantee safety during home rehabilitation. 5: Difficulty in setting up internet facilities at home or elsewhere. 6: Difficulty in installing remote rehabilitation exercise equipment at home or elsewhere. 7: Presence of comorbidities that contraindicate exercise or are deemed to pose a high risk for exercise. 8: Patients who meet the contraindications or discontinuation criteria for cancer rehabilitation or cardiac rehabilitation. 9: If the attending hematologist, cardiologist, rehabilitation specialist, and principal investigator of this study determine that participation is inappropriate.

Design outcomes

Primary

MeasureTime frame
Completion Rate of Rehabilitation: The proportion of patients who completed the rehabilitation as defined by the protocol (including cases where rehabilitation was continued with reduced exercise prescriptions according to the patient's condition) among those who underwent rehabilitation.

Secondary

MeasureTime frame
1: Interruption Rate of Rehabilitation: The proportion of patients who discontinued the protocol intervention among those who underwent rehabilitation. 2: Incidence Rate of Adverse Events: The proportion of adverse events by grade that occurred in this study, with all registered cases as the denominator.

Countries

Japan, not applicable

Contacts

Public ContactNorifumi Bekki

Cnacer Institute Hospital of Japanese Foundation for Cancer Research

norifumi.bekki@jfcr.or.jp+81-3-3520-0111

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026