"Exercise Intervention to Increase Physical Activity in Young Sarcoma Survivors (Sport Ist Herzenssache)"
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Individualized Exercise Program.
- Who it may be relevant to
- Registry conditions: Bone Sarcoma, Soft Tissue Sarcoma (STS). Basic parameters: from 15 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Effects of an Individualized, Smartwatch-Supported Exercise Intervention on Physical Activity, Cardiorespiratory Fitness, Limb Function and Quality of Life in Adolescent and Young Adult Survivors of Bone and Soft Tissue Sarcoma: A Randomized Controlled Trial (Sport Ist Herzenssache)
Overview
Survivors of bone and soft tissue sarcoma often face long-term health problems after their cancer treatment, such as muscle weakness, joint stiffness, and reduced heart and lung fitness. Because of this, many survivors are less physically active than their healthy peers, which can further increase their risk of heart disease and other late effects later in life. This study, called "Sport ist Herzenssache" ("Sports is a Matter of the Heart"), tests whether a personalized exercise program can help young survivors (aged 15-39) become more physically active. All participants receive a fitness tracker (smartwatch) to monitor their daily activity. Half of the participants are randomly assigned to also receive an individualized home exercise plan, including strength and endurance training, with some sessions guided online by an exercise specialist. Before and after an 8-week exercise period (with continuous activity tracking for about 13 weeks total), participants complete simple physical tests (such as walking and balance tests), a heart and fitness check-up, and questionnaires about their quality of life and energy levels. The main goal is to find out whether the personalized exercise plan helps participants become more active in daily life, measured in minutes of moderate-to-intense activity per day. The study also looks at effects on heart health, physical function, and overall well-being. The results will help determine whether structured exercise support should become a standard part of long-term follow-up care for young sarcoma survivors.
Detailed description
Survivors of pediatric and adolescent bone and soft tissue sarcomas frequently experience long-term sequelae including reduced muscle strength, impaired joint mobility, and diminished cardiorespiratory fitness, often resulting from multimodal oncological therapy (surgery, chemotherapy, radiotherapy). These sequelae contribute to persistently low levels of physical activity compared to healthy peers, which in turn is associated with an elevated risk of cardiovascular disease-a risk already increased 2- to 10-fold in this population due to cardiotoxic treatment exposure (e.g., anthracyclines, thoracic irradiation). Despite established benefits of physical activity in reducing fatigue, improving quality of life, and lowering cardiovascular morbidity, structured exercise programs are not yet routinely integrated into long-term follow-up care for sarcoma survivors.
This monocentric, randomized controlled trial ("Sport ist Herzenssache") aims to evaluate the effectiveness of an individualized, partially supervised, digitally supported exercise intervention in increasing moderate-to-vigorous physical activity (MVPA) among adolescent and young adult (AYA) survivors of bone and soft tissue sarcoma during routine oncological follow-up care.
Eligible participants are aged 15-39 years, have completed local tumor therapy (surgery and/or radiotherapy) more than 12 months prior to enrollment, and are receiving follow-up care at the Sarcoma Center of the University Hospital Essen. Following informed consent, participants will be randomized 1:1, stratified by tumor location (lower extremity/pelvis, thorax, other), into two groups: (1) a control group receiving a wearable activity tracker (Garmin Venu® Sq 2) for self-monitoring, and (2) an intervention group receiving the same wearable device plus an individualized, partially supervised home-based exercise program over 8 weeks, combining endurance/cardio training (60 min/week) and strength/aerobic sessions (3 × 30 min/week), in accordance with WHO physical activity recommendations and exercise guidelines for cancer survivors. Supervised sessions are delivered via video conferencing by trained exercise therapists.
Physical activity is monitored continuously via wearable device across a total observation period of approximately 13-15 weeks in both groups. At baseline and after the observation period, participants undergo a comprehensive assessment including functional mobility testing (Timed Up and Down Stairs, Timed Up and Go, 6-Minute Walk Test, modified Clinical Test of Sensory Interaction in Balance), goniometry, handheld dynamometry, and cardiopulmonary evaluation (spiroergometry, echocardiography, 12-lead ECG). Patient-reported outcomes include health-related quality of life, cancer-related fatigue, physical functioning, and self-rated health status.
The primary endpoint is average daily MVPA (minutes/day), measured objectively via wearable device. Secondary endpoints include cardiorespiratory fitness (VO2max), cardiovascular risk factors, orthopedic function, and patient-reported quality of life and fatigue. Exploratory analyses will examine correlations between MVPA and physical/psychosocial outcomes, as well as associations with physical activity levels during acute cancer therapy.
Based on a two-sided t-test with α = 0.05 and 80% power, a total sample size of n = 42 (21 per arm) is required to detect a clinically meaningful increase in MVPA from an expected baseline of 40 min/day (SD = 20) toward the WHO-recommended target of 60 min/day. Accounting for an estimated 10% dropout rate, recruitment aims to enroll 46 participants over a two-year period.
This study addresses a critical gap in survivorship care by generating evidence on the feasibility and efficacy of a structured, individualized exercise intervention to promote long-term physical activity, cardiovascular health, and quality of life in young sarcoma survivors, with the goal of informing the integration of exercise therapy as a standard component of long-term oncological follow-up care.
Interventions
- Behavioral Individualized Exercise Program
An 8-week individualized, partially supervised home-based exercise program designed to increase physical activity in accordance with exercise guidelines for cancer survivors. The program is tailored to each participant's functional status, based on a comprehensive baseline assessment (functional testing, cardiopulmonary evaluation, and a structured counseling session addressing individual interests, concerns, and goals). The program consists of: Endurance training: 60 minutes/week (e.g., walki
Primary outcome measures
- Moderate-to-Vigorous Physical Activity (MVPA) [Time frame: Baseline (1 week after inlcusion), after 9 weeks and after 13 weeks]
- Functional Mobility - Stair Climbing [Time frame: Baseline (1 week after inclusion), after 9 weeks and after 13 weeks]
- Functional Mobility - Gait Speed [Time frame: Baseline (1 week after inclusion), after 9 weeks and after 13 weeks]
- Functional Exercise Capacity [Time frame: Baseline (1 week after inclusion), after 9 weeks and after 13 weeks]
- Postural Balance [Time frame: Baseline (1 week after inclusion), after 9 weeks and after 13 weeks]
- Joint Range of Motion [Time frame: Baseline (1 week after inclusion), after 9 weeks and after 13 weeks]
- Muscle Strength [Time frame: Baseline (1 week after inclusion), after 9 weeks and after 13 weeks]
- Cardiorespiratory Fitness (VO2peak) [Time frame: Baseline (1 week after inclusion), after 9 weeks and after 13 weeks]
- Left Ventricular Ejection Fraction (LVEF) [Time frame: Baseline (1 week after inclusion), after 9 weeks and after 13 weeks]
- Resting Heart Rate [Time frame: Baseline (1 week after inclusion), after 9 weeks and after 13 weeks]
Secondary outcome measures (8)
- Health-Related Quality of Life - Physical Component Summary (SF-36 PCS, Adults) [Time frame: Baseline (1 week after inclusion), after 9 weeks and after 13 weeks]
- Health-Related Quality of Life - Mental Component Summary (SF-36 MCS, Adults) [Time frame: Baseline (1 week after inclusion), after 9 weeks and after 13 weeks]
- Health-Related Quality of Life - Physical Health Summary Score (Minors, PedsQL) [Time frame: Baseline (1 week after inclusion), after 9 weeks and after 13 weeks]
- Health-Related Quality of Life - Psychosocial Health Summary Score (Minors, PedsQL) [Time frame: Baseline (1 week after inclusion), after 9 weeks and after 13 weeks]
- Cancer-Related Fatigue [Time frame: Baseline (1 week after inclusion), after 9 weeks and after 13 weeks]
- Limb Function (Extremity-Specific) [Time frame: Baseline (1 week after inclusion), after 9 weeks and after 13 weeks]
- Orthopedic Long-Term Complications [Time frame: Baseline (1 week after inclusion), after 9 weeks and after 13 weeks]
- Self-Reported Physical Activity (SQUASH) [Time frame: Baseline (1 week after inclusion), after 9 weeks and after 13 weeks]
Eligibility criteria
Inclusion criteria
- Diagnosis of bone or soft tissue sarcoma
- Currently receiving follow-up care at the tumor orthopedics clinic of University Hospital Essen
- Age ≥15 and ≤39 years at time of enrollment
- Completion of local tumor therapy (surgery and/or definitive radiotherapy) more than 12 months prior to enrollment
- Access to a smartphone for data synchronization with the wearable device
Exclusion criteria
- Contraindications to physical activity
- Language barriers preventing communication in German
- Known or current psychiatric condition impairing the ability to understand study requirements, participate in the study, or provide informed consent
- Pregnancy
- Planned absence of more than 2 weeks during the study period (e.g., due to rehabilitation stays)
- Pre-existing average MVPA >60 minutes/day at baseline
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07729059 · Sport ist Herzenssache