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Telerehabilitation and Lymphoma Patients

Primary Purpose

Lymphoma, Rehabilitation

Status
Completed
Phase
Not Applicable
Locations
Czechia
Study Type
Interventional
Intervention
Telerehablitation using heart rate monitor
Sponsored by
Brno University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Lymphoma

Eligibility Criteria

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

Inclusion Criteria:

  • Lymphoma patients post-treatment (except ongoing adjuvant treatment)
  • Post-treatment period not exceeding 3 months
  • Internet connection at home
  • Literacy with information and communication technology
  • Patients who agreed with informed consent

Exclusion Criteria:

  • Inability to perform a cardiopulmonary exercise test
  • Psychological severe or cognitive disorders
  • Contraindications for cardiopulmonary exercise testing
  • Other exercise limitations (musculoskeletal disorders)
  • Planned intervention or operation
  • Participants who are enrolled in or participate in other rehabilitation program
  • Participants who plan to be or are included in other studies

Sites / Locations

  • University Hospital Brno

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Home-based telerehabilitation exercise

Arm Description

Exercise training is conducted in the patient's home conditions using modern technology to transfer medical data remotely - the participants receive a heart rate monitor and sensor. To know what to do and how to exercise, the first (1-2) exercise training sessions will be controlled by the physiotherapist in a rehabilitation clinic in the hospital, who creates individual exercise training for each patient. The patient's training data will be downloaded and updated regularly via the internet platform and clinicians will evaluate these results and provide patients with telephone feedback.

Outcomes

Primary Outcome Measures

Cardiorespiratory fitness (CRF)
Peak oxygen uptake (VO2peak) during the cardiopulmonary exercise test

Secondary Outcome Measures

Body composition (Total muscle mass in kilograms)
Total muscle mass is the amount of muscle in body, including skeletal muscles, smooth muscles, and cardiac muscles. Total muscle mass will be measured by bioelectrical impedance analysis.
Body composition (Body fat mass in kilograms)
Body fat mass is the actual weight of fat in body. Body fat mass will be measured by bioelectrical impedance analysis.
Body composition (Body weight in kilograms)
Body weight is the measurement of weight without items located on the person. Body weight will be measured by bioelectrical impedance analysis.
Incidence of treatment-emergent adverse events assessed by 5 grade scale
Participants will be encouraged to use the contact details for reporting the incidence of treatment-emergent 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
Exercise adherence
Exercise adherence is defined as number of exercise sessions attended of a possible 36 offered by the exercise intervention program. Exercise adherence will be determined by participant exercise web datasheet review at 12 weeks.
Exercise compliance
Number of participants who attend atleast 70% of prescribed exercise sessions measured by exercise datasheet at 12 weeks. (70% of prescribed exercise sessions = 25 exercise sessions in 12 weeks)

Full Information

First Posted
March 26, 2021
Last Updated
July 19, 2022
Sponsor
Brno University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04822389
Brief Title
Telerehabilitation and Lymphoma Patients
Official Title
Effect of the Physical Exercise Training Using Telerehabilitation Among Lymphoma Patients: A Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
April 1, 2021 (Actual)
Primary Completion Date
April 26, 2022 (Actual)
Study Completion Date
May 31, 2022 (Actual)

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
Data Monitoring Committee
No

5. Study Description

Brief Summary
This study aims to examine the feasibility and effect of a home-based short-term telerehabilitation exercise intervention using heart rate monitor and internet platform in patients with lymphoma.
Detailed Description
Fifteen lymphoma cancer patients post-treatment (except adjuvant treatment) will be enrolled in the study. Cardiorespiratory fitness (peak oxygen consumption), adverse events, body composition and adherence to exercise prescription will be evaluated at baseline, 12-week, and year after enrollment.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Home-based telerehabilitation exercise
Arm Type
Experimental
Arm Description
Exercise training is conducted in the patient's home conditions using modern technology to transfer medical data remotely - the participants receive a heart rate monitor and sensor. To know what to do and how to exercise, the first (1-2) exercise training sessions will be controlled by the physiotherapist in a rehabilitation clinic in the hospital, who creates individual exercise training for each patient. The patient's training data will be downloaded and updated regularly via the internet platform and clinicians will evaluate these results and provide patients with telephone feedback.
Intervention Type
Device
Intervention Name(s)
Telerehablitation using heart rate monitor
Intervention Description
Eligible participants will undergo 12 weeks of physical exercise using a heart rate monitor and internet platform at home. The participants will regularly (minimum once per week) upload the exercise data from the heart rate monitor into the internet platform. An exercise telerehabilitation session consists of the warm-up phase, aerobic phase (30 - 50 minutes gradually increasing exercise duration; heart rate zone based on baseline cardiopulmonary exercise test) and cool-down phase. The exercise training period is set to 3 times a week for 12 weeks. Study participants will receive user guides developed by research team with detailed instructions regarding equipment set-up, training protocol, and contact information. Also, participants will receive weekly phone calls from week 0 to week 12 to monitor adverse events, encourage compliance and adherence to the study protocol, address any subject questions or concerns, and collect information regarding participants' current symptomatology.
Primary Outcome Measure Information:
Title
Cardiorespiratory fitness (CRF)
Description
Peak oxygen uptake (VO2peak) during the cardiopulmonary exercise test
Time Frame
Change from baseline to 12 weeks and 1-year
Secondary Outcome Measure Information:
Title
Body composition (Total muscle mass in kilograms)
Description
Total muscle mass is the amount of muscle in body, including skeletal muscles, smooth muscles, and cardiac muscles. Total muscle mass will be measured by bioelectrical impedance analysis.
Time Frame
Change from baseline to 12 weeks and 1-year
Title
Body composition (Body fat mass in kilograms)
Description
Body fat mass is the actual weight of fat in body. Body fat mass will be measured by bioelectrical impedance analysis.
Time Frame
Change from baseline to 12 weeks and 1-year
Title
Body composition (Body weight in kilograms)
Description
Body weight is the measurement of weight without items located on the person. Body weight will be measured by bioelectrical impedance analysis.
Time Frame
Change from baseline to 12 weeks and 1-year
Title
Incidence of treatment-emergent adverse events assessed by 5 grade scale
Description
Participants will be encouraged to use the contact details for reporting the incidence of treatment-emergent 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 baseline to 12 weeks
Title
Exercise adherence
Description
Exercise adherence is defined as number of exercise sessions attended of a possible 36 offered by the exercise intervention program. Exercise adherence will be determined by participant exercise web datasheet review at 12 weeks.
Time Frame
12 weeks
Title
Exercise compliance
Description
Number of participants who attend atleast 70% of prescribed exercise sessions measured by exercise datasheet at 12 weeks. (70% of prescribed exercise sessions = 25 exercise sessions in 12 weeks)
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Lymphoma patients post-treatment (except ongoing adjuvant treatment) Post-treatment period not exceeding 3 months Internet connection at home Literacy with information and communication technology Patients who agreed with informed consent Exclusion Criteria: Inability to perform a cardiopulmonary exercise test Psychological severe or cognitive disorders Contraindications for cardiopulmonary exercise testing Other exercise limitations (musculoskeletal disorders) Planned intervention or operation Participants who are enrolled in or participate in other rehabilitation program Participants who plan to be or are included in other studies
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
ZIP/Postal Code
62500
Country
Czechia

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Telerehabilitation and Lymphoma Patients

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