Telerehabilitation and Lymphoma Patients

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.

Study Overview

• Status: Completed
• Conditions: Lymphoma; Rehabilitation
• Intervention / Treatment: Device: Telerehablitation using heart rate monitor

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 Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Czechia
  • Brno, Czechia, 62500
    • University Hospital Brno

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 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.

Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cardiorespiratory fitness (CRF)	Peak oxygen uptake (VO2peak) during the cardiopulmonary exercise test	Change from baseline to 12 weeks and 1-year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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	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.	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)	12 weeks

Collaborators and Investigators

• Sponsor: Brno University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2021
• Primary Completion (Actual): April 26, 2022
• Study Completion (Actual): May 31, 2022

Study Registration Dates

• First Submitted: March 26, 2021
• First Submitted That Met QC Criteria: March 26, 2021
• First Posted (Actual): March 30, 2021

Study Record Updates

• Last Update Posted (Actual): July 20, 2022
• Last Update Submitted That Met QC Criteria: July 19, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Lymphoma
• Other Study ID Numbers: IPRHO-KOREHAB2021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No