Telerehabilitation in Hemato-oncological Survivors
- Conditions
- Hematologic MalignancyLymphoma
- Interventions
- Device: Center-based trainingDevice: Home-based training
- Registration Number
- NCT05779605
- Lead Sponsor
- Brno University Hospital
- Brief 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 80
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
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Center-based training Center-based training 12 weeks of centre-based exercise training under supervision physiotherapists specializing in exercise rehabilitation. The participants receive a heart rate monitor and sensor. The patients in the Center-based training group receive an individually tailored training program on a treadmill and a bicycle ergometer. Three sessions per week will be performed (36 sessions overall). Home-based training Home-based training 12 weeks of home-based exercise training using modern technology to transfer exercise data remotely. The participants receive a heart rate monitor and sensor. Three sessions per week will be performed (36 sessions overall).
- Primary Outcome Measures
Name Time Method Cardiorespiratory fitness Change from baseline to 12 weeks and 52 weeks Peak oxygen uptake during cardiopulmonary exercise test
- Secondary Outcome Measures
Name Time Method Satisfaction - self-completed questionnaire 12 weeks and 52 weeks 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").
Muscle mass Change from baseline to 12 weeks and 52 weeks Total muscle mass in kilograms will be measured by bioelectrical impedance analysis.
Incidence of exercise adverse events assessed by 5 grade scale Data will be recorded continuously from the intervention's baseline for 12 weeks and then for 52 weeks Participants will be encouraged to use the contact details for reporting incidence of exercise adverse events at any time throughout the study period. The type, incidence, and severity of adverse events by scale (Grade 1: Mild, asymptomatic or mild symptoms; Grade 2: Moderate, minimal; Grade 3: Severe or medically significant; Grade 4: Life-threatening consequences; and Grade 5: Death) will be noted.
Body water Change from baseline to 12 weeks and 52 weeks Total body water in liters will be measured by bioelectrical impedance analysis.
Health-related quality of life Change from baseline to 12 weeks and 52 weeks 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
Training adherence (Number of compliant participants) 12 weeks Evaluation of the total number of compliant participants (The criterium of compliance with the rehabilitation program is set at 70% of the prescribed training lessons, 100% = 36 lessons)
Body fat percentage Change from baseline to 12 weeks and 52 weeks Body fat percentage will be measured by bioelectrical impedance analysis.
Maximum Grip Strength Change from baseline to 12 weeks and 52 weeks Maximum grip strength during dynamometer evaluation
Trial Locations
- Locations (1)
University Hospital Brno
🇨🇿Brno, Czechia