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Completed

NCT Number: NCT04822389

Telerehabilitation and Lymphoma Patients

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Brno

Brno, 62500, Czechia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Cardiorespiratory fitness (CRF)

    Time frame: Change from baseline to 12 weeks and 1-year

    Peak oxygen uptake (VO2peak) during the cardiopulmonary exercise test

Secondary outcomes

  1. Body composition (Total muscle mass in kilograms)

    Time frame: 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.

  2. Body composition (Body fat mass in kilograms)

    Time frame: 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.

  3. Body composition (Body weight in kilograms)

    Time frame: 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.

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

    Time frame: 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

  5. Exercise adherence

    Time frame: 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.

  6. Exercise compliance

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

Brno University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Mar 30, 2021
Registry last updated
Jul 20, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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