Telerehabilitation in Hemato-oncological Survivors

NCT05779605 | Recruiting

• 1 other identifier: NU23-09-00048
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Hematologic Malignancy; Lymphoma

Outcome Measures

Primary Outcomes (1)

• Cardiorespiratory fitness

  Peak oxygen uptake during cardiopulmonary exercise test

  Change from baseline to 12 weeks and 52 weeks

Secondary Outcomes (8)

• Health-related quality of life

  Change from baseline to 12 weeks and 52 weeks

• Satisfaction - self-completed questionnaire

  12 weeks and 52 weeks

• Body water

  Change from baseline to 12 weeks and 52 weeks

• Muscle mass

  Change from baseline to 12 weeks and 52 weeks

• Body fat percentage

  Change from baseline to 12 weeks and 52 weeks

Study Arms (2)

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).

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).

Device: Center-based training

Interventions

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.

Home-based training

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.

Center-based training

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Brno University Hospital: lead

Study Sites (1)

University Hospital Brno

Brno, Czechia

RECRUITING

Related Publications (1)

• 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.

  PMID: 39080734 DERIVED

MeSH Terms

Conditions

Hematologic Neoplasms; Lymphoma

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Neoplasms by Histologic Type; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Ladislav Batalik

  Department of Rehabilitation, University Hospital Brno, Czech Republic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Katerina Filakova

CONTACT

00420532233123; filakova.katerina@fnbrno.cz

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 8, 2023
• First Posted: March 22, 2023
• Study Start: April 1, 2023
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: September 29, 2025

Record last verified: 2025-09

Locations

CZ (1)