Telerehabilitation in Hemato-oncological Survivors
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorBrno University Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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)
Trial design
Design model
Parallel
Treatments tested in this trial
Home-based training
DevicePatients 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.
Center-based training
DevicePatients 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.
Treatment groups
80 Participants
are divided into 2 treatment groupsGroup A: Home-based trainingExperimental treatment 1 intervention
Group B: Center-based trainingActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Cardiorespiratory fitness
Peak oxygen uptake during cardiopulmonary exercise test
Time frame
Change from baseline to 12 weeks and 52 weeksSecondary outcomes
1
Health-related quality of life
Health-related quality of life (SF-36 Form) yields a score for each domain of health. All domains are scored on a scale from 0 (negative health) to 100 (positive health), with 100 representing the best possible health state
Time frame
Change from baseline to 12 weeks and 52 weeks2
Satisfaction - self-completed questionnaire
Subjects will be provided with a 5-item self-completed questionnaire developed by our research team that will measure their satisfaction with the intervention they received and the study in general. The items will be presented in the form of statements to which subjects will be asked to respond using a 1-5 Likert scale ("strongly agree", "agree", "not sure", "disagree", and strongly disagree").
Time frame
12 weeks and 52 weeks3
Body water
Total body water in liters will be measured by bioelectrical impedance analysis.
Time frame
Change from baseline to 12 weeks and 52 weeks4
Muscle mass
Total muscle mass in kilograms will be measured by bioelectrical impedance analysis.
Time frame
Change from baseline to 12 weeks and 52 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov