Telerehabilitation in Hemato-oncological Survivors

Trial Title: Telerehabilitation in Hemato-oncological Survivors

NCT ID: NCT05779605

Condition: Hematologic Malignancy
Lymphoma

Conditions: Official terms:
Hematologic Neoplasms

Study type: Interventional

Study phase: N/A

Overall status: Recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Supportive Care

Masking: Single (Outcomes Assessor)

Intervention:

Intervention type: Device
Intervention name: Home-based training
Description: 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. During exercise, patients will use a wearable heart rate monitor (Polar M430, a commercially available device designed for long-term use). Patients will be instructed to properly use the wearable sensor and upload training data to a web-based platform (Polar Flow) via the Internet. Furthermore, patients will be asked to choose their preferred training modality at home (cycling, walking, Nordic walking) and receive instructions and advice.
Arm group label: Home-based training

Intervention type: Device
Intervention name: Center-based training
Description: 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.
Arm group label: Center-based training

Summary: 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.

Detailed description: 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.

Criteria for eligibility:
Criteria:
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

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: University Hospital Brno

Address:
City: Brno
Country: Czechia

Status: Recruiting

Contact:
Last name: Ladislav Batalik, PhD

Phone: 00420532231111
Email: batalik.ladislav@fnbrno.cz

Start date: April 1, 2023

Completion date: December 31, 2026

Lead sponsor:
Agency: Brno University Hospital
Agency class: Other

Source: Brno University Hospital

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05779605