Bone SarcomaNCT07729059
"Exercise Intervention to Increase Physical Activity in Young Sarcoma Survivors (Sport Ist Herzenssache)"
A study testing Individualized Exercise Program in people with Bone Sarcoma and Soft Tissue Sarcoma (STS), run by Universität Duisburg-Essen.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Bone Sarcoma, Soft Tissue Sarcoma (STS)
- What is being tested?
- Individualized Exercise Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2026to 31 Jul 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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)
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.
Read more
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.
Read the 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.
- Conditions
- Bone Sarcoma, Soft Tissue Sarcoma (STS)
- Being tested
- Individualized Exercise Program
- Keywords
- Exercise, Physical Activity, Soft Tissue Sarcoma, Bone Sarcoma, Cancer Survivorship, Adolescents and Young Adults, Cardiorespiratory Fitness, Quality of Life, Limb Function
- Medical subject headings
- Bone Neoplasms, Sarcoma, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Individualized Exercise ProgramBehavioural
Also called Structured Home-Based Exercise Intervention, Partially Supervised Training Program, Individualized Physical Activity 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., 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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group (Exercise + Smartwatch) | Experimental | 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. Receives: Behavioral: Individualized Exercise Program |
| Control Group (Smartwatch Only) | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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)
Measured: 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)
Measured: 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
Measured: 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)
Measured: 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
Measured: Baseline (1 week after inclusion), after 9 weeks and after 13 weeks
Muscle Strength
Muscle strength measured in Newtons via handheld dynamometry
Measured: 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)
Measured: Baseline (1 week after inclusion), after 9 weeks and after 13 weeks
Left Ventricular Ejection Fraction (LVEF)
Assessed via transthoracic echocardiography, measured in percent (%)
Measured: 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
Measured: Baseline (1 week after inclusion), after 9 weeks and after 13 weeks
QTc Interval
Assessed via 12-lead ECG, measured in milliseconds
Measured: Baseline (1 week after inclusion), after 9 weeks and after 13 weeks
Secondary outcomes (8)
Health-Related Quality of Life - Physical Component Summary (SF-36 PCS, Adults)
Points on a scale (0-100, higher = better); participants ≥18 years
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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)
Measured: 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)
Measured: 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
Measured: 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
Measured: Baseline (1 week after inclusion), after 9 weeks and after 13 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2026
- Study start1 Aug 2026 (estimated)
- Primary completion31 Jul 2028 (estimated)
- Study completion31 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone SarcomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universität Duisburg-Essen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Miriam Götte, Universität Duisburg-Essen
- Investigators
- Miriam Götte, Dr. rer. medic., Principal investigator, University Hospital, EssenIna Elisa Kirchberg, Dr. med., Principal investigator, University Hospital, EssenUta Dirksen, Univ.-Prof. Dr. med., Principal investigator, University Hospital, Essen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07729059
- Sponsor's protocol ID
- Sport ist Herzenssache
- Status last verified
- Jul 2026
- First submitted
- 16 Jul 2026
- Last updated
- 27 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT07729059
- Acronym / sponsor ID
- Sport ist Herzenssache
- Conditions
- Bone Sarcoma, Soft Tissue Sarcoma (STS)
- Keywords
- Exercise, Physical Activity, Soft Tissue Sarcoma, Bone Sarcoma, Cancer Survivorship, Adolescents and Young Adults, Cardiorespiratory Fitness, Quality of Life
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- Universität Duisburg-EssenUniversity, hospital or other
- Study start
- 1 Aug 2026 (estimated)
- Primary completion
- 31 Jul 2028 (estimated)
- Study completion
- 31 Jul 2028 (estimated)
- First posted
- 27 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group (Exercise + Smartwatch) | Experimental | Behavioral: Individualized Exercise ProgramParticipants 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. |
| Control Group (Smartwatch Only) | No intervention | –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. |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Individualized Exercise ProgramAlso: Structured Home-Based Exercise Intervention, Partially Supervised Training Program, Individualized Physical Activity ProgramAn 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. | Behavioural | Intervention Group (Exercise + Smartwatch) |
Primary outcome
Moderate-to-Vigorous Physical Activity (MVPA)
Time frame: Baseline (1 week after inlcusion), after 9 weeks and after 13 weeks
Average daily MVPA, measured objectively in minutes/day via wearable activity tracker (Garmin Venu® Sq 2), compared between intervention and control group
Functional Mobility - Stair Climbing
Time frame: Baseline (1 week after inclusion), after 9 weeks and after 13 weeks
Time (in seconds) to ascend and descend 14 stairs (Timed Up and Down Stairs, TUDS)
Functional Mobility - Gait Speed
Time frame: Baseline (1 week after inclusion), after 9 weeks and after 13 weeks
Time (in seconds) to stand up, walk 3 meters, and sit down (Timed Up and Go, TUG)
Functional Exercise Capacity
Time frame: Baseline (1 week after inclusion), after 9 weeks and after 13 weeks
Distance walked in 6 minutes (6-Minute Walk Test, 6MWT), measured in meters
Postural Balance
Time frame: Baseline (1 week after inclusion), after 9 weeks and after 13 weeks
Time (in seconds) maintaining single-leg stance on varying surfaces (modified Clinical Test of Sensory Interaction in Balance, CTSIB-M)
Joint Range of Motion
Time frame: Baseline (1 week after inclusion), after 9 weeks and after 13 weeks
Range of motion of affected joints, measured in degrees via goniometry
Muscle Strength
Time frame: Baseline (1 week after inclusion), after 9 weeks and after 13 weeks
Muscle strength measured in Newtons via handheld dynamometry
Cardiorespiratory Fitness (VO2peak)
Time frame: Baseline (1 week after inclusion), after 9 weeks and after 13 weeks
Peak oxygen uptake (VO2peak in ml/kg/min) assessed via cardiopulmonary exercise testing (spiroergometry)
Left Ventricular Ejection Fraction (LVEF)
Time frame: Baseline (1 week after inclusion), after 9 weeks and after 13 weeks
Assessed via transthoracic echocardiography, measured in percent (%)
Resting Heart Rate
Time frame: Baseline (1 week after inclusion), after 9 weeks and after 13 weeks
Assessed via 12-lead ECG, measured in beats per minute
QTc Interval
Time frame: Baseline (1 week after inclusion), after 9 weeks and after 13 weeks
Assessed via 12-lead ECG, measured in milliseconds
8 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Miriam Götte, Dr. rer. medic. principal investigator
University Hospital, Essen
Ina Elisa Kirchberg, Dr. med. principal investigator
University Hospital, Essen
Uta Dirksen, Univ.-Prof. Dr. med. principal investigator
University Hospital, Essen
Questions about this trial
What is this clinical trial studying?
A study testing Individualized Exercise Program in people with Bone Sarcoma and Soft Tissue Sarcoma (STS), run by Universität Duisburg-Essen.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 27 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ina Elisa Kirchberg, Dr. med. (+49 201 723 8084, InaElisa.Kirchberg@uk-essen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Moderate-to-Vigorous Physical Activity (MVPA) (time frame: Baseline (1 week after inlcusion), after 9 weeks and after 13 weeks). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2026; AzTrials last refreshed its copy on 30 Oct 2026.