Telerehabilitation in Hemato-oncological Survivors (Tele@home)

June 26, 2023 updated by: Ladislav Batalik, Brno University Hospital

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
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.
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cardiorespiratory fitness
Time Frame: Change from baseline to 12 weeks and 52 weeks
Peak oxygen uptake during cardiopulmonary exercise test
Change from baseline to 12 weeks and 52 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Health-related quality of life
Time Frame: 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
Change from baseline to 12 weeks and 52 weeks
Satisfaction - self-completed questionnaire
Time Frame: 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").
12 weeks and 52 weeks
Body water
Time Frame: Change from baseline to 12 weeks and 52 weeks
Total body water in liters will be measured by bioelectrical impedance analysis.
Change from baseline to 12 weeks and 52 weeks
Muscle mass
Time Frame: Change from baseline to 12 weeks and 52 weeks
Total muscle mass in kilograms will be measured by bioelectrical impedance analysis.
Change from baseline to 12 weeks and 52 weeks
Body fat percentage
Time Frame: Change from baseline to 12 weeks and 52 weeks
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
Time Frame: 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.
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
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
Time Frame: Change from baseline to 12 weeks and 52 weeks
Maximum grip strength during dynamometer evaluation
Change from baseline to 12 weeks and 52 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Brno University Hospital

Investigators

  • Principal Investigator: Ladislav Batalik, Department of Rehabilitation, University Hospital Brno, Czech Republic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2023

Primary Completion (Estimated)

December 31, 2025

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

March 8, 2023

First Submitted That Met QC Criteria

March 20, 2023

First Posted (Actual)

March 22, 2023

Study Record Updates

Last Update Posted (Actual)

June 27, 2023

Last Update Submitted That Met QC Criteria

June 26, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NU23-09-00048

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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