LymphomaNCT04822389
Telerehabilitation and Lymphoma Patients
A study testing Telerehablitation using heart rate monitor in people with Lymphoma and Rehabilitation, run by Brno University Hospital at 1 site in Czechia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymphoma, Rehabilitation
- What is being tested?
- Telerehablitation using heart rate monitor
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteCzechia
- Study dates
- 1 Apr 2021to 31 May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of the Physical Exercise Training Using Telerehabilitation Among Lymphoma Patients: A Pilot Study
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.
Read the 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.
- Conditions
- Lymphoma, Rehabilitation
- Being tested
- Telerehablitation using heart rate monitor
- Medical subject headings
- Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telerehablitation using heart rate monitorDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Home-based telerehabilitation exercise | Experimental | 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. Receives: Device: Telerehablitation using heart rate monitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiorespiratory fitness (CRF)
Peak oxygen uptake (VO2peak) during the cardiopulmonary exercise test
Measured: Change from baseline to 12 weeks and 1-year
Secondary outcomes (6)
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.
Measured: Change from baseline to 12 weeks and 1-year
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.
Measured: Change from baseline to 12 weeks and 1-year
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.
Measured: Change from baseline to 12 weeks and 1-year
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
Measured: Data will be recorded continuously from the baseline to 12 weeks
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.
Measured: 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)
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2021
- Study start1 Apr 2021
- Primary completion26 Apr 2022
- Study completion31 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for LymphomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brno University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ladislav Batalik, Brno University Hospital
- Investigators
- Ladislav Batalik, Principal investigator, Department of Rehabilitation, University Hospital Brno, Czech Republic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04822389
- Sponsor's protocol ID
- IPRHO-KOREHAB2021
- Status last verified
- Jul 2022
- First submitted
- 26 Mar 2021
- Last updated
- 20 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Filakova K, Janikova A, Felsoci M, Dosbaba F, Su JJ, Pepera G, Batalik L. Home-based cardio-oncology rehabilitation using a telerehabilitation platform in hematological cancer survivors: a feasibility study. BMC Sports Sci Med Rehabil. 2023 Mar 23;15(1):38. doi: 10.1186/s13102-023-00650-2.
PubMed 36959613
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of the Physical Exercise Training Using Telerehabilitation Among Lymphoma Patients: A Pilot Study
- ClinicalTrials.gov ID
- NCT04822389
- Acronym / sponsor ID
- IPRHO-KOREHAB2021
- Conditions
- Lymphoma, Rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Brno University HospitalUniversity, hospital or other
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 26 Apr 2022 (actual)
- Study completion
- 31 May 2022 (actual)
- First posted
- 30 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Home-based telerehabilitation exercise | Experimental | Device: Telerehablitation using heart rate monitorExercise 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Telerehablitation using heart rate monitorEligible 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. | Device | Home-based telerehabilitation exercise |
Primary outcome
Cardiorespiratory fitness (CRF)
Time frame: Change from baseline to 12 weeks and 1-year
Peak oxygen uptake (VO2peak) during the cardiopulmonary exercise test
6 secondary outcomes
Body composition (Total muscle mass in kilograms)
Time frame: Change from baseline to 12 weeks and 1-year
Body composition (Body fat mass in kilograms)
Time frame: Change from baseline to 12 weeks and 1-year
Body composition (Body weight in kilograms)
Time frame: Change from baseline to 12 weeks and 1-year
Incidence of treatment-emergent adverse events assessed by 5 grade scale
Time frame: Data will be recorded continuously from the baseline to 12 weeks
Exercise adherence
Time frame: 12 weeks
Exercise compliance
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2022.
- Derived from this study: PubMed 36959613Filakova K, Janikova A, Felsoci M, Dosbaba F, Su JJ, Pepera G, Batalik L. Home-based cardio-oncology rehabilitation using a telerehabilitation platform in hematological cancer survivors: a feasibility study. BMC Sports Sci Med Rehabil. 2023 Mar 23;15(1):38. doi: 10.1186/s13102-023-00650-2.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ladislav Batalik principal investigator
Department of Rehabilitation, University Hospital Brno, Czech Republic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telerehablitation using heart rate monitor in people with Lymphoma and Rehabilitation, run by Brno University Hospital at 1 site in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiorespiratory fitness (CRF) (time frame: Change from baseline to 12 weeks and 1-year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04822389, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2022.