Clinical trial NCT05779605: Telerehabilitation in Hemato-oncological Survivors
Official title: Remotely Monitored Rehabilitation in Hemato-oncological Survivors After Treatment: The Tele@Home Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hematologic Malignancy
Lymphoma
Lead sponsor: Brno University Hospital
Sponsor class: OTHER
First posted: 2023-03-22
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Cardiorespiratory fitness
timeFrame: Change from baseline to 12 weeks and 52 weeks
Secondary outcomes:
measure: Health-related quality of life
timeFrame: Change from baseline to 12 weeks and 52 weeks
measure: Satisfaction - self-completed questionnaire
timeFrame: 12 weeks and 52 weeks
measure: Body water
timeFrame: Change from baseline to 12 weeks and 52 weeks
measure: Muscle mass
timeFrame: Change from baseline to 12 weeks and 52 weeks
measure: Body fat percentage
timeFrame: Change from baseline to 12 weeks and 52 weeks
measure: Incidence of exercise adverse events assessed by 5 grade scale
timeFrame: Data will be recorded continuously from the intervention's baseline for 12 weeks and then for 52 weeks
measure: Training adherence (Number of compliant participants)
timeFrame: 12 weeks
measure: Maximum Grip Strength
timeFrame: Change from baseline to 12 weeks and 52 weeks
Other outcomes:
Locations:
city: Brno
country: Czechia
facility: University Hospital Brno
Study officials:
affiliation: Department of Rehabilitation, University Hospital Brno, Czech Republic
name: Ladislav Batalik
role: PRINCIPAL_INVESTIGATOR
References: