Halt Aging in Survivors of Blood Cancers

Официальное название

Halt Aging in Survivors of Blood Cancers: the HALTAging-1 Study

Обзор

Older survivors of blood cancer are at a high risk of accelerated biological aging, which increases their risk of developing multiple aging-related conditions. Whereas physical exercise can improve overall health, older cancer survivors do not meet the recommended physical activity, highlighting the need to develop behavioral interventions to increase adherence. Several other knowledge gaps exist to implement exercise interventions in older survivors of blood cancer; the dose and duration of exercise necessary to slow biological aging in older blood cancer survivors remain unknown. To bridge these gaps in knowledge, we have designed a Phase 2 randomized control trial to test the effects of behavioral and exercise interventions on various outcomes.

Вмешательства

• Поведенческое Behavioral Coaching Intervention
  Intervention arm incorporating virtually supervised moderate-intensity aerobic exercise and behavioral intervention/coaching to improve adherence
• Поведенческое Virtual Exercise Platform
  Access to a virtual exercise platform that provides exercise classes and educational sessions for older survivors of blood cancer

Первичные конечные точки

• Percentage of participants who adhered to the exercise regimen at 6-months post enrollment. [Срок оценки: 6 Months from start of program]
• Percentage of participants who adhered to the exercise regimen at 12-months post enrollment. [Срок оценки: 12 Months from start of program.]

Вторичные конечные точки (1)

• Physical Function (6- Minute Walk Test Distance) [Срок оценки: 6 months from randomization]

Критерии участия

Критерии включения

• Age ≥50 years
• A history of hematological malignancy
• Participants must be able to and willingly give informed consent

Критерии исключения

• Patients receiving intensive induction or consolidation chemotherapy. Maintenance chemotherapy, or lower-intensity chemotherapy for an indolent hematological malignancy is allowed.
• Neurodegenerative disease (e.g. Alzheimer's dementia), stroke, or uncontrolled psychotic disorders (e.g. schizophrenia or bipolar disorder) in the past 3 months if those disorders are considered significant enough to impair participation in the study.
• Illnesses such as clinical evidence of decompensated heart failure, unstable angina, or orthopedic or neuromuscular disorders that could limit safe participation in aerobic exercise.
• Cardiopulmonary exercise test results that preclude safe exercise (e.g., life-threatening arrhythmia, balance difficulties, peak VO2 <10 ml/kg/min).
• Estimated life expectancy of less than 6 months (that precludes assessment of study primary endpoint).
• Self-reported pregnancy or the possibility of pregnancy.
• Participants who do not plan to follow up at the participating center.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

США · 1 центр

• University of Nebraska Medical Center — Omaha

Идентификаторы

NCT: NCT07292272 · 606-25-FB

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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