Telerehabilitation and Lymphoma Patients

Lymphoma Clinical Trial

Official title:

Effect of the Physical Exercise Training Using Telerehabilitation Among Lymphoma Patients: A Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04822389
• Other study ID #: IPRHO-KOREHAB2021
• Status: Completed
• Phase: N/A
• Start date: April 1, 2021
• Est. completion date: May 31, 2022

Study information

• Verified date: July 2022
• Source: Brno University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: May 31, 2022
• Est. primary completion date: April 26, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lymphoma
• Rehabilitation

Intervention

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.

Locations

Country	Name	City	State
Czechia	University Hospital Brno	Brno

Sponsors (1)

Lead Sponsor	Collaborator
Brno University Hospital

Country where clinical trial is conducted

Czechia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cardiorespiratory fitness (CRF)	Peak oxygen uptake (VO2peak) during the cardiopulmonary exercise test	Change from baseline to 12 weeks and 1-year
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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