Telerehabilitation in Hemato-oncological Survivors

Официальное название

Remotely Monitored Rehabilitation in Hemato-oncological Survivors After Treatment: The Tele@Home Study

Обзор

This study investigates whether the 12-week home-based exercise training with remote guidance and telemonitoring compared to regular center-based training leads to better long-term cardiorespiratory fitness and physical activity levels in post-treatment patients with lymphoma.

Подробное описание

80 lymphoma cancer patients post-treatment (except adjuvant treatment) will be enrolled in the study. Cardiorespiratory fitness (peak oxygen consumption), adverse events, body composition, quality of life, costs and adherence to exercise prescription will be evaluated at baseline, 12-week, and year after enrollment.

Investigators assume that home-based training with remote guidance and telemonitoring with objective training data obtained during rehabilitation after cancer treatment will improve long-term motivation and effectiveness of independent training in cancer survivors, resulting in superior cardiorespiratory fitness and physical activity levels.

Вмешательства

• Устройство Home-based training
  Patients will be instructed to perform three weekly training sessions at home (30 to 50 min/session, at an intensity of 70-85% of their maximum heart rate). Patients in the home training group complete the first three training sessions in the clinic under direct supervision. During these sessions, patients are introduced to the duration and intensity of training. The trainer will provide remote guidance (feedback on training frequency, duration, and intensity) via telephone call once a week. Dur
• Устройство Center-based training
  Patients receive three training sessions a week with 30 to 50 min duration at 70 - 90% of their maximal heart rate at the outpatient clinic under direct supervision. Exercise modalities will be walking on a treadmill, riding a bicycle ergometer, and resistance training. Physiotherapists will track the attendance rate and training adherence during the training program.

Первичные конечные точки

• Cardiorespiratory fitness [Срок оценки: Change from baseline to 12 weeks and 52 weeks]

Вторичные конечные точки (8)

• Health-related quality of life [Срок оценки: Change from baseline to 12 weeks and 52 weeks]
• Satisfaction - self-completed questionnaire [Срок оценки: 12 weeks and 52 weeks]
• Body water [Срок оценки: Change from baseline to 12 weeks and 52 weeks]
• Muscle mass [Срок оценки: Change from baseline to 12 weeks and 52 weeks]
• Body fat percentage [Срок оценки: Change from baseline to 12 weeks and 52 weeks]
• Incidence of exercise adverse events assessed by 5 grade scale [Срок оценки: Data will be recorded continuously from the intervention's baseline for 12 weeks and then for 52 weeks]
• Training adherence (Number of compliant participants) [Срок оценки: 12 weeks]
• Maximum Grip Strength [Срок оценки: Change from baseline to 12 weeks and 52 weeks]

Критерии участия

Inclusion Criteria: Participants

• with hemato-oncological malignancy / lymphoma (in last two months)
• after cancer systemic chemotherapy-based treatment
• with clinically stable state
• with the ability to perform a cardiopulmonary exercise test
• with the ability to understand and write in the Czech language
• with an internet connection at home
• literacy with information and communication technology

Exclusion Criteria: Participants

• with acute heart disease or decompensation in the previous six weeks,
• with psychological severe, cognitive disorders,
• serious training limitations (musculoskeletal disorders)
• currently carried out the recommendations for physical activity (150min per week)
• who take part in a training program under supervision elsewhere

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

Простое слепое

Основная цель

Поддерживающая терапия

Центры проведения

Чехия · 1 центр

• University Hospital Brno — Brno

Публикации

• Chamradova K, Batalik L, Winnige P, Dosbaba F, Hartman M, Batalikova K, Janikova A, Nehyba S, Felsoci M, Pepera G, Su JJ. Effects of home-based exercise with telehealth guidance in lymphoma cancer survivors entering cardio-oncology rehabilitation: rationale and design of the tele@home study. Cardiooncology. 2024 Jul 30;10(1):46. doi: 10.1186/s40959-024-00249-7. PMID 39080734

Идентификаторы

NCT: NCT05779605 · NU23-09-00048

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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