Telerehabilitation and Lymphoma Patients

Not Applicable

Completed

• Conditions: Lymphoma; Rehabilitation
• Interventions: Device: Telerehablitation using heart rate monitor

• Registration Number: NCT04822389
• Lead Sponsor: Brno University Hospital

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.

Study Timeline

• Study First Submitted: 2021-03-26
• Study First Submitted QC: 2021-03-26
• Study First Posted: 2021-03-30
• Study Start: 2021-04-01
• Primary Completion: 2022-04-26
• Study Completion: 2022-05-31
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-19
• Last Update Posted: 2022-07-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Home-based telerehabilitation exercise	Telerehablitation using heart rate monitor	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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Exercise compliance	12 weeks	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)
Body composition (Total muscle mass in kilograms)	Change from baseline to 12 weeks and 1-year	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 weight in kilograms)	Change from baseline to 12 weeks and 1-year	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	Data will be recorded continuously from the baseline to 12 weeks	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
Body composition (Body fat mass in kilograms)	Change from baseline to 12 weeks and 1-year	Body fat mass is the actual weight of fat in body. Body fat mass will be measured by bioelectrical impedance analysis.
Exercise adherence	12 weeks	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.

Trial Locations

Locations (1)

University Hospital Brno; 🇨🇿 Brno, Czechia