Hematologic MalignancyTele@homeNCT05779605
Telerehabilitation in Hemato-oncological Survivors
A study testing Home-based training and Center-based training in people with Hematologic Malignancy and Lymphoma, run by Brno University Hospital at 1 site in Czechia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hematologic Malignancy, Lymphoma
- What is being tested?
- Home-based training and Center-based training
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteCzechia
- Study dates
- 1 Apr 2023to 29 Sep 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Remotely Monitored Rehabilitation in Hemato-oncological Survivors After Treatment: The Tele@Home Study
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.
Read the 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.
- Conditions
- Hematologic Malignancy, Lymphoma
- Being tested
- Home-based training, Center-based training
- Medical subject headings
- Hematologic Neoplasms, Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home-based trainingDevice
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.
Center-based trainingDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Device: Home-based training |
| 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). Receives: Device: Center-based training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiorespiratory fitness
Peak oxygen uptake during cardiopulmonary exercise test
Measured: Change from baseline to 12 weeks and 52 weeks
Secondary outcomes (8)
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
Measured: Change from baseline to 12 weeks and 52 weeks
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").
Measured: 12 weeks and 52 weeks
Body water
Total body water in liters will be measured by bioelectrical impedance analysis.
Measured: Change from baseline to 12 weeks and 52 weeks
Muscle mass
Total muscle mass in kilograms will be measured by bioelectrical impedance analysis.
Measured: Change from baseline to 12 weeks and 52 weeks
Body fat percentage
Body fat percentage will be measured by bioelectrical impedance analysis.
Measured: 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.
Measured: 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)
Measured: 12 weeks
Maximum Grip Strength
Maximum grip strength during dynamometer evaluation
Measured: Change from baseline to 12 weeks and 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2023
- Study start1 Apr 2023
- Primary completion1 Sep 2026
- Study completion29 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hematologic MalignancyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brno University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ladislav Batalik, Brno University Hospital
- Investigators
- Ladislav Batalik, Principal investigator, Department of Rehabilitation, University Hospital Brno, Czech Republic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05779605
- Sponsor's protocol ID
- NU23-09-00048
- Acronym
- Tele@home
- Status last verified
- Sep 2026
- First submitted
- 8 Mar 2023
- Last updated
- 30 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 39080734
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Remotely Monitored Rehabilitation in Hemato-oncological Survivors After Treatment: The Tele@Home Study
- ClinicalTrials.gov ID
- NCT05779605
- Acronym / sponsor ID
- Tele@home / NU23-09-00048
- Conditions
- Hematologic Malignancy, Lymphoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Brno University HospitalUniversity, hospital or other
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 1 Sep 2026 (actual)
- Study completion
- 29 Sep 2026 (actual)
- First posted
- 22 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Home-based training | Experimental | Device: Home-based training12 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 | Device: Center-based training12 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Home-based trainingPatients 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. | Device | Home-based training |
| Center-based trainingPatients 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. | Device | Center-based training |
Primary outcome
Cardiorespiratory fitness
Time frame: Change from baseline to 12 weeks and 52 weeks
Peak oxygen uptake during cardiopulmonary exercise test
8 secondary outcomes
Health-related quality of life
Time frame: Change from baseline to 12 weeks and 52 weeks
Satisfaction - self-completed questionnaire
Time frame: 12 weeks and 52 weeks
Body water
Time frame: Change from baseline to 12 weeks and 52 weeks
Muscle mass
Time frame: Change from baseline to 12 weeks and 52 weeks
Body fat percentage
Time frame: Change from baseline to 12 weeks and 52 weeks
Incidence of exercise adverse events assessed by 5 grade scale
Time frame: Data will be recorded continuously from the intervention's baseline for 12 weeks and then for 52 weeks
Training adherence (Number of compliant participants)
Time frame: 12 weeks
Maximum Grip Strength
Time frame: Change from baseline to 12 weeks and 52 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2026.
- Derived from this study: PubMed 39080734Chamradova 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.
Related trials for Hematologic Malignancy
RecruitingPhase 2
Tafasitamab With Acalabrutinib and Venetoclax for the Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Chronic Lymphocytic Leukemia, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Not yet recruitingPhase 2
Study of YKST02 in Adults With Relapsed or Refractory Multiple Myeloma
Relapsed or Refractory Multiple Myeloma (RRMM)
RecruitingPhase 2
Engaging T-cells to Eliminate MRD in Newly Diagnosed Myeloma Optimizing Response With Talquetmab and Teclistamab (ROTATE)
Multiple Myeloma
Active, not recruitingPhase 3
A Phase III Study of Eque-cel in Subjects With Len-refractory RRMM (FUMANBA-03)
Multiple Myeloma
Active, not recruitingPhase 1/2
A Window of Opportunity Trial to Learn if Linvoseltamab is Safe and Well Tolerated, and How Well it Works in Adult Participants With Recently Diagnosed Multiple Myeloma Who Have Not Already Received Treatment
Multiple Myeloma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ladislav Batalik principal investigator
Department of Rehabilitation, University Hospital Brno, Czech Republic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Home-based training and Center-based training in people with Hematologic Malignancy and Lymphoma, run by Brno University Hospital at 1 site in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiorespiratory fitness (time frame: Change from baseline to 12 weeks and 52 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05779605, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2026.