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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Home-based training | Experimental | 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). |
|
| Center-based training | Active Comparator | 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Home-based training | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Cardiorespiratory fitness | Peak oxygen uptake during cardiopulmonary exercise test | Change from baseline to 12 weeks and 52 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Change from baseline to 12 weeks and 52 weeks |
| Satisfaction - self-completed questionnaire |
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Inclusion Criteria: Participants
Exclusion Criteria: Participants
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Katerina Filakova | Contact | 00420532233123 | filakova.katerina@fnbrno.cz |
| Name | Affiliation | Role |
|---|---|---|
| Ladislav Batalik | Department of Rehabilitation, University Hospital Brno, Czech Republic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Brno | Recruiting | Brno | Czechia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39080734 | Derived | 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. |
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| ID | Term |
|---|---|
| D019337 | Hematologic Neoplasms |
| D008223 | Lymphoma |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| Center-based training | Device | 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. |
|
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"). |
| 12 weeks and 52 weeks |
| Body water | Total body water in liters will be measured by bioelectrical impedance analysis. | Change from baseline to 12 weeks and 52 weeks |
| Muscle mass | Total muscle mass in kilograms will be measured by bioelectrical impedance analysis. | Change from baseline to 12 weeks and 52 weeks |
| Body fat percentage | Body fat percentage will be measured by bioelectrical impedance analysis. | Change from baseline to 12 weeks and 52 weeks |
| Incidence of exercise adverse events assessed by 5 grade scale | 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. | Data will be recorded continuously from the intervention's baseline for 12 weeks and then for 52 weeks |
| Training adherence (Number of compliant participants) | 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) | 12 weeks |
| Maximum Grip Strength | Maximum grip strength during dynamometer evaluation | Change from baseline to 12 weeks and 52 weeks |
| D009370 |
| Neoplasms by Histologic Type |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |