Telerehabilitation in Hemato-oncological Survivors

Lymphoma Clinical Trial

— Tele@home  

Official title:

Remotely Monitored Rehabilitation in Hemato-oncological Survivors After Treatment: The Tele@Home Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05779605
• Other study ID #: NU23-09-00048
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2023
• Est. completion date: December 31, 2026

Study information

• Verified date: June 2023
• Source: Brno University Hospital
• Contact: Katerina Filakova
• Phone: 00420532233123
• Email: filakova.katerina[@]fnbrno.cz
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study investigates whether the 12-week home-based exercise training with remote guidance and telemonitoring compared to regular center-based training leads to better long-term cardiorespiratory fitness and physical activity levels in post-treatment patients with lymphoma.

Description:

80 lymphoma cancer patients post-treatment (except adjuvant treatment) will be enrolled in the study. Cardiorespiratory fitness (peak oxygen consumption), adverse events, body composition, quality of life, costs and adherence to exercise prescription will be evaluated at baseline, 12-week, and year after enrollment.

Investigators assume that home-based training with remote guidance and telemonitoring with objective training data obtained during rehabilitation after cancer treatment will improve long-term motivation and effectiveness of independent training in cancer survivors, resulting in superior cardiorespiratory fitness and physical activity levels.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria: Participants

• with hemato-oncological malignancy / lymphoma (in last two months)

• after cancer systemic chemotherapy-based treatment

• with clinically stable state

• with the ability to perform a cardiopulmonary exercise test

• with the ability to understand and write in the Czech language

• with an internet connection at home

• literacy with information and communication technology

Exclusion Criteria: Participants

• with acute heart disease or decompensation in the previous six weeks,

• with psychological severe, cognitive disorders,

• serious training limitations (musculoskeletal disorders)

• currently carried out the recommendations for physical activity (150min per week)

• who take part in a training program under supervision elsewhere

Related Conditions & MeSH terms

• Hematologic Malignancy
• Hematologic Neoplasms
• Lymphoma

Intervention

Device:
• Home-based training
Patients will be instructed to perform three weekly training sessions at home (30 to 50 min/session, at an intensity of 70-85% of their maximum heart rate). Patients in the home training group complete the first three training sessions in the clinic under direct supervision. During these sessions, patients are introduced to the duration and intensity of training. The trainer will provide remote guidance (feedback on training frequency, duration, and intensity) via telephone call once a week. During exercise, patients will use a wearable heart rate monitor (Polar M430, a commercially available device designed for long-term use). Patients will be instructed to properly use the wearable sensor and upload training data to a web-based platform (Polar Flow) via the Internet. Furthermore, patients will be asked to choose their preferred training modality at home (cycling, walking, Nordic walking) and receive instructions and advice.
• Center-based training
Patients receive three training sessions a week with 30 to 50 min duration at 70 - 90% of their maximal heart rate at the outpatient clinic under direct supervision. Exercise modalities will be walking on a treadmill, riding a bicycle ergometer, and resistance training. Physiotherapists will track the attendance rate and training adherence during the training program.

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	Peak oxygen uptake during cardiopulmonary exercise test	Change from baseline to 12 weeks and 52 weeks
Secondary	Health-related quality of life	Health-related quality of life (SF-36 Form) yields a score for each domain of health. All domains are scored on a scale from 0 (negative health) to 100 (positive health), with 100 representing the best possible health state	Change from baseline to 12 weeks and 52 weeks
Secondary	Satisfaction - self-completed questionnaire	Subjects will be provided with a 5-item self-completed questionnaire developed by our research team that will measure their satisfaction with the intervention they received and the study in general. The items will be presented in the form of statements to which subjects will be asked to respond using a 1-5 Likert scale ("strongly agree", "agree", "not sure", "disagree", and strongly disagree").	12 weeks and 52 weeks
Secondary	Body water	Total body water in liters will be measured by bioelectrical impedance analysis.	Change from baseline to 12 weeks and 52 weeks
Secondary	Muscle mass	Total muscle mass in kilograms will be measured by bioelectrical impedance analysis.	Change from baseline to 12 weeks and 52 weeks
Secondary	Body fat percentage	Body fat percentage will be measured by bioelectrical impedance analysis.	Change from baseline to 12 weeks and 52 weeks
Secondary	Incidence of exercise adverse events assessed by 5 grade scale	Participants will be encouraged to use the contact details for reporting incidence of exercise 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 intervention's baseline for 12 weeks and then for 52 weeks
Secondary	Training adherence (Number of compliant participants)	Evaluation of the total number of compliant participants (The criterium of compliance with the rehabilitation program is set at 70% of the prescribed training lessons, 100% = 36 lessons)	12 weeks
Secondary	Maximum Grip Strength	Maximum grip strength during dynamometer evaluation	Change from baseline to 12 weeks and 52 weeks