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Telerehabilitation in Hemato-oncological Survivors (Tele@home)

Primary Purpose

Hematologic Malignancy, Lymphoma

Status
Recruiting
Phase
Not Applicable
Locations
Czechia
Study Type
Interventional
Intervention
Home-based training
Center-based training
Sponsored by
Brno University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Hematologic Malignancy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Hospital BrnoRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Home-based training

Center-based training

Arm Description

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).

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).

Outcomes

Primary Outcome Measures

Cardiorespiratory fitness
Peak oxygen uptake during cardiopulmonary exercise test

Secondary Outcome Measures

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
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").
Body water
Total body water in liters will be measured by bioelectrical impedance analysis.
Muscle mass
Total muscle mass in kilograms will be measured by bioelectrical impedance analysis.
Body fat percentage
Body fat percentage will be measured by bioelectrical impedance analysis.
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.
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)
Maximum Grip Strength
Maximum grip strength during dynamometer evaluation

Full Information

First Posted
March 8, 2023
Last Updated
June 26, 2023
Sponsor
Brno University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05779605
Brief Title
Telerehabilitation in Hemato-oncological Survivors
Acronym
Tele@home
Official Title
Remotely Monitored Rehabilitation in Hemato-oncological Survivors After Treatment: The Tele@Home Study
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 1, 2023 (Actual)
Primary Completion Date
December 31, 2025 (Anticipated)
Study Completion Date
December 31, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Brno University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hematologic Malignancy, Lymphoma

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Home-based training
Arm Type
Experimental
Arm Description
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).
Arm Title
Center-based training
Arm Type
Active Comparator
Arm Description
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).
Intervention Type
Device
Intervention Name(s)
Home-based training
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Center-based training
Intervention Description
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.
Primary Outcome Measure Information:
Title
Cardiorespiratory fitness
Description
Peak oxygen uptake during cardiopulmonary exercise test
Time Frame
Change from baseline to 12 weeks and 52 weeks
Secondary Outcome Measure Information:
Title
Health-related quality of life
Description
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
Title
Satisfaction - self-completed questionnaire
Description
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
Title
Body water
Description
Total body water in liters will be measured by bioelectrical impedance analysis.
Time Frame
Change from baseline to 12 weeks and 52 weeks
Title
Muscle mass
Description
Total muscle mass in kilograms will be measured by bioelectrical impedance analysis.
Time Frame
Change from baseline to 12 weeks and 52 weeks
Title
Body fat percentage
Description
Body fat percentage will be measured by bioelectrical impedance analysis.
Time Frame
Change from baseline to 12 weeks and 52 weeks
Title
Incidence of exercise adverse events assessed by 5 grade scale
Description
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
Title
Training adherence (Number of compliant participants)
Description
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
Title
Maximum Grip Strength
Description
Maximum grip strength during dynamometer evaluation
Time Frame
Change from baseline to 12 weeks and 52 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Katerina Filakova
Phone
00420532233123
Email
filakova.katerina@fnbrno.cz
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ladislav Batalik
Organizational Affiliation
Department of Rehabilitation, University Hospital Brno, Czech Republic
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Brno
City
Brno
Country
Czechia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ladislav Batalik, PhD
Phone
00420532231111
Email
batalik.ladislav@fnbrno.cz

12. IPD Sharing Statement

Learn more about this trial

Telerehabilitation in Hemato-oncological Survivors

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