Telerehabilitation and Lymphoma Patients

NCT04822389 | Completed

• 1 other identifier: IPRHO-KOREHAB2021
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Lymphoma; Rehabilitation

Outcome Measures

Primary Outcomes (1)

• Cardiorespiratory fitness (CRF)

  Peak oxygen uptake (VO2peak) during the cardiopulmonary exercise test

  Change from baseline to 12 weeks and 1-year

Secondary Outcomes (6)

• Body composition (Total muscle mass in kilograms)

  Change from baseline to 12 weeks and 1-year

• Body composition (Body fat mass in kilograms)

  Change from baseline to 12 weeks and 1-year

• Body composition (Body weight in kilograms)

  Change from baseline to 12 weeks and 1-year

• Incidence of treatment-emergent adverse events assessed by 5 grade scale

  Data will be recorded continuously from the baseline to 12 weeks

• Exercise adherence

  12 weeks

Study Arms (1)

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.

Device: Telerehablitation using heart rate monitor

Interventions

Telerehablitation using heart rate monitor 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.

Home-based telerehabilitation exercise

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Brno University Hospital: lead

Study Sites (1)

University Hospital Brno

Brno, 62500, Czechia

Location

Related Publications (1)

• 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.

  PMID: 36959613 DERIVED

MeSH Terms

Conditions

Lymphoma

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Ladislav Batalik

  Department of Rehabilitation, University Hospital Brno, Czech Republic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 26, 2021
• First Posted: March 30, 2021
• Study Start: April 1, 2021
• Primary Completion: April 26, 2022
• Study Completion: May 31, 2022
• Last Updated: July 20, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (1)