Telerehabilitation and Lymphoma Patients

NCT ID: NCT04822389

Last Updated: 2022-07-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-01
• Study Completion Date: 2022-05-31

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.

Conditions

Lymphoma; Rehabilitation

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Home-based telerehabilitation exercise

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.

Group Type: EXPERIMENTAL

Telerehablitation using heart rate monitor

Intervention Type: DEVICE

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.

Interventions

Telerehablitation using heart rate monitor

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.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Brno University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Ladislav Batalik

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ladislav Batalik

Role: PRINCIPAL_INVESTIGATOR

Department of Rehabilitation, University Hospital Brno, Czech Republic

Locations

University Hospital Brno

Brno, , Czechia

Countries

Czechia

References

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.

Reference Type: DERIVED

PMID: 36959613 (View on PubMed)

Other Identifiers

IPRHO-KOREHAB2021

Identifier Type: -

Identifier Source: org_study_id