An interventional study of Individualized Exercise Program in Bone Sarcoma and Soft Tissue Sarcoma (STS), sponsored by Universität Duisburg-Essen. Not yet recruiting. Open to participants aged 15 Years and older. Per ClinicalTrials.gov, last updated 2026-07-27.
Sponsored by Universität Duisburg-Essen · Not applicable, Interventional, and Supportive care
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.
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.
258 studies on the registry are indexed under Bone Neoplasms; 68 are open to participants now.
This study's planned enrollment of 46 is close to the median of 44 across 163 interventional studies indexed under Bone Neoplasms.
Browse Bone Neoplasms studies →Universität Duisburg-Essen is the lead sponsor of 85 studies on the registry; 14 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants receive a wearable activity tracker (Garmin Venu® Sq 2) and an individualized, partially supervised home-based exercise program over 8 weeks, comprising weekly endurance training (60 min/week) and three weekly aerobic/strength sessions (30 min each), based on individual counseling regarding personal interests, needs, and functional status. Supervised sessions via video conferencing occur in weeks 1, 2, 3, 5, and 7.
Behavioral: Individualized Exercise Program
Participants receive the same wearable activity tracker (Garmin Venu® Sq 2) for self-monitoring of physical activity, without a structured individualized exercise program. Individual exercise counseling is offered after study completion.
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., walking, cycling), Aerobic and strength training: 3 sessions/week, 30 minutes each, targeting endurance, strength, coordination, mobility, balance, and flexibility Training sessions are self-administered at home, supported by a digital training platform providing instructional videos, and monitored via a wearable activity tracker. Partial supervision is provided through live video-conferencing sessions conducted by a trained exercise therapist in weeks 1, 2, 3, 5, and 7.
Also known as: Structured Home-Based Exercise Intervention, Partially Supervised Training Program, Individualized Physical Activity Program
Moderate-to-Vigorous Physical Activity (MVPA)
Average daily MVPA, measured objectively in minutes/day via wearable activity tracker (Garmin Venu® Sq 2), compared between intervention and control group
Time frame: Baseline (1 week after inlcusion), after 9 weeks and after 13 weeks
Functional Mobility - Stair Climbing
Time (in seconds) to ascend and descend 14 stairs (Timed Up and Down Stairs, TUDS)
Time frame: Baseline (1 week after inclusion), after 9 weeks and after 13 weeks
Functional Mobility - Gait Speed
Time (in seconds) to stand up, walk 3 meters, and sit down (Timed Up and Go, TUG)
Time frame: Baseline (1 week after inclusion), after 9 weeks and after 13 weeks
Functional Exercise Capacity
Distance walked in 6 minutes (6-Minute Walk Test, 6MWT), measured in meters
Time frame: Baseline (1 week after inclusion), after 9 weeks and after 13 weeks
Postural Balance
Time (in seconds) maintaining single-leg stance on varying surfaces (modified Clinical Test of Sensory Interaction in Balance, CTSIB-M)
Time frame: Baseline (1 week after inclusion), after 9 weeks and after 13 weeks
Joint Range of Motion
Range of motion of affected joints, measured in degrees via goniometry
Time frame: Baseline (1 week after inclusion), after 9 weeks and after 13 weeks
Muscle Strength
Muscle strength measured in Newtons via handheld dynamometry
Time frame: Baseline (1 week after inclusion), after 9 weeks and after 13 weeks
Cardiorespiratory Fitness (VO2peak)
Peak oxygen uptake (VO2peak in ml/kg/min) assessed via cardiopulmonary exercise testing (spiroergometry)
Time frame: Baseline (1 week after inclusion), after 9 weeks and after 13 weeks
Left Ventricular Ejection Fraction (LVEF)
Assessed via transthoracic echocardiography, measured in percent (%)
Time frame: Baseline (1 week after inclusion), after 9 weeks and after 13 weeks
Resting Heart Rate
Assessed via 12-lead ECG, measured in beats per minute
Time frame: Baseline (1 week after inclusion), after 9 weeks and after 13 weeks
QTc Interval
Assessed via 12-lead ECG, measured in milliseconds
Time frame: Baseline (1 week after inclusion), after 9 weeks and after 13 weeks
Health-Related Quality of Life - Physical Component Summary (SF-36 PCS, Adults)
Points on a scale (0-100, higher = better); participants ≥18 years
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)
Points on a scale (0-100, higher = better); participants ≥18 years
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)
Physical Health Summary Score of the Pediatric Quality of Life Inventory (PedsQL), age-appropriate version (13-18 years), measured in points on a scale (0-100, higher scores indicate better health-related quality of life). Applied to participants \<18 years.
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)
Psychosocial Health Summary Score of the Pediatric Quality of Life Inventory (PedsQL), age-appropriate version (13-18 years), calculated as the mean of the Emotional, Social, and School Functioning subscales, measured in points on a scale (0-100, higher scores indicate better health-related quality of life). Applied to participants \<18 years.
Time frame: Baseline (1 week after inclusion), after 9 weeks and after 13 weeks
Cancer-Related Fatigue
Assessed via the Multidimensional Fatigue Inventory (MFI-20), comprising 5 subscales (General Fatigue, Physical Fatigue, Reduced Activity, Reduced Motivation, Mental Fatigue)
Time frame: Baseline (1 week after inclusion), after 9 weeks and after 13 weeks
Limb Function (Extremity-Specific)
Lower/upper extremity function assessed via the Toronto Extremity Salvage Score (TESS)
Time frame: Baseline (1 week after inclusion), after 9 weeks and after 13 weeks
Orthopedic Long-Term Complications
Incidence of orthopedic complications (e.g., prosthesis-related issues, need for re-operation) recorded during follow-up
Time frame: Baseline (1 week after inclusion), after 9 weeks and after 13 weeks
Self-Reported Physical Activity (SQUASH)
Subjectively assessed physical activity level, measured via the Short QUestionnaire to ASsess Health-enhancing physical activity (SQUASH), German version
Time frame: Baseline (1 week after inclusion), after 9 weeks and after 13 weeks
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This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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Universität Duisburg-Essen