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RecruitingNCT05779605Tele@homeUpdated Sep 29, 2025

Telerehabilitation in Hemato-oncological Survivors

An interventional study of Home-based training and Center-based training in Hematologic Malignancy and Lymphoma, sponsored by Brno University Hospital. Recruiting at 1 site in Czechia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-09-29.

Sponsored by Brno University Hospital · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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 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.

02

Conditions studied

  • Hematologic Malignancy
  • Lymphoma
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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
04

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
80 participants (estimated)

Study arms

  • Experimental
    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).

    Device: Home-based training

  • Active comparator
    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).

    Device: Center-based training

Interventions

  • DeviceHome-based training

    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.

  • DeviceCenter-based training

    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.

05

What researchers measure

Primary outcomes

  1. Cardiorespiratory fitness

    Peak oxygen uptake during cardiopulmonary exercise test

    Time frame: Change from baseline to 12 weeks and 52 weeks

Secondary 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 weeks

  2. 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 weeks

  3. Body water

    Total body water in liters will be measured by bioelectrical impedance analysis.

    Time frame: Change from baseline to 12 weeks and 52 weeks

  4. Muscle mass

    Total muscle mass in kilograms will be measured by bioelectrical impedance analysis.

    Time frame: Change from baseline to 12 weeks and 52 weeks

  5. Body fat percentage

    Body fat percentage will be measured by bioelectrical impedance analysis.

    Time frame: Change from baseline to 12 weeks and 52 weeks

  6. 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.

    Time frame: Data will be recorded continuously from the intervention's baseline for 12 weeks and then for 52 weeks

  7. 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)

    Time frame: 12 weeks

  8. Maximum Grip Strength

    Maximum grip strength during dynamometer evaluation

    Time frame: Change from baseline to 12 weeks and 52 weeks

06

Study locations

1 of 1 sites recruiting
07

References and documents

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 ↗
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Registry details

Key details

Study ID
NCT05779605
Lead sponsor
Brno University Hospital
Responsible party
Ladislav Batalik (Principal Investigator, Brno University Hospital) — Principal investigator
First posted
Mar 22, 2023
Start date
Apr 1, 2023
Primary completion
Dec 31, 2025 (estimated)
Completion
Dec 31, 2026 (estimated)
Last update
Sep 29, 2025

Study contacts

Katerina Filakova
Contact
filakova.katerina@fnbrno.cz
00420532233123
Ladislav Batalik
principal investigator · Department of Rehabilitation, University Hospital Brno, Czech Republic

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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