"Exercise Intervention to Increase Physical Activity in Young Sarcoma Survivors (Sport Ist Herzenssache)"
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.
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.
Panoramica dello studio
Stato
Stato
Condizioni
Condizioni
Intervento / Trattamento
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Tipo di studio
Iscrizione (Stimato)
Iscrizione
Fase
Fase
- Non applicabile
Contatti e Sedi
Contatto studio
Contatto studio
- Nome: Ina Elisa Kirchberg, Dr. med.
- Numero di telefono: +49 201 723 8084
- Email: InaElisa.Kirchberg@uk-essen.de
Backup dei contatti dello studio
- Nome: Miriam Götte, Dr. rer. medic.
- Numero di telefono: +49 201 723 8083
- Email: miriam.goette@uk-essen.de
Criteri di partecipazione
Criteri di ammissibilità
Criteri di ammissibilità
Età idonea allo studio
- Bambino
- Adulto
- Adulto più anziano
Accetta volontari sani
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Terapia di supporto
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Numero di armi
Armi e interventi
Gruppo di partecipanti / ArmGruppo di partecipanti / Arm |
Intervento / TrattamentoIntervento / Trattamento |
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Sperimentale: Intervention Group (Exercise + Smartwatch)
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.
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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.
Altri nomi:
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Nessun intervento: Control Group (Smartwatch Only)
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.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Moderate-to-Vigorous Physical Activity (MVPA)
Lasso di tempo: Baseline (1 week after inlcusion), after 9 weeks and after 13 weeks
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Average daily MVPA, measured objectively in minutes/day via wearable activity tracker (Garmin Venu® Sq 2), compared between intervention and control group
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Baseline (1 week after inlcusion), after 9 weeks and after 13 weeks
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Functional Mobility - Stair Climbing
Lasso di tempo: Baseline (1 week after inclusion), after 9 weeks and after 13 weeks
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Time (in seconds) to ascend and descend 14 stairs (Timed Up and Down Stairs, TUDS)
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Baseline (1 week after inclusion), after 9 weeks and after 13 weeks
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Functional Mobility - Gait Speed
Lasso di tempo: Baseline (1 week after inclusion), after 9 weeks and after 13 weeks
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Time (in seconds) to stand up, walk 3 meters, and sit down (Timed Up and Go, TUG)
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Baseline (1 week after inclusion), after 9 weeks and after 13 weeks
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Functional Exercise Capacity
Lasso di tempo: Baseline (1 week after inclusion), after 9 weeks and after 13 weeks
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Distance walked in 6 minutes (6-Minute Walk Test, 6MWT), measured in meters
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Baseline (1 week after inclusion), after 9 weeks and after 13 weeks
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Postural Balance
Lasso di tempo: Baseline (1 week after inclusion), after 9 weeks and after 13 weeks
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Time (in seconds) maintaining single-leg stance on varying surfaces (modified Clinical Test of Sensory Interaction in Balance, CTSIB-M)
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Baseline (1 week after inclusion), after 9 weeks and after 13 weeks
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Joint Range of Motion
Lasso di tempo: Baseline (1 week after inclusion), after 9 weeks and after 13 weeks
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Range of motion of affected joints, measured in degrees via goniometry
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Baseline (1 week after inclusion), after 9 weeks and after 13 weeks
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Muscle Strength
Lasso di tempo: Baseline (1 week after inclusion), after 9 weeks and after 13 weeks
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Muscle strength measured in Newtons via handheld dynamometry
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Baseline (1 week after inclusion), after 9 weeks and after 13 weeks
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Cardiorespiratory Fitness (VO2peak)
Lasso di tempo: Baseline (1 week after inclusion), after 9 weeks and after 13 weeks
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Peak oxygen uptake (VO2peak in ml/kg/min) assessed via cardiopulmonary exercise testing (spiroergometry)
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Baseline (1 week after inclusion), after 9 weeks and after 13 weeks
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Left Ventricular Ejection Fraction (LVEF)
Lasso di tempo: Baseline (1 week after inclusion), after 9 weeks and after 13 weeks
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Assessed via transthoracic echocardiography, measured in percent (%)
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Baseline (1 week after inclusion), after 9 weeks and after 13 weeks
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Resting Heart Rate
Lasso di tempo: Baseline (1 week after inclusion), after 9 weeks and after 13 weeks
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Assessed via 12-lead ECG, measured in beats per minute
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Baseline (1 week after inclusion), after 9 weeks and after 13 weeks
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QTc Interval
Lasso di tempo: Baseline (1 week after inclusion), after 9 weeks and after 13 weeks
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Assessed via 12-lead ECG, measured in milliseconds
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Baseline (1 week after inclusion), after 9 weeks and after 13 weeks
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Misure di risultato secondarie
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Health-Related Quality of Life - Physical Component Summary (SF-36 PCS, Adults)
Lasso di tempo: Baseline (1 week after inclusion), after 9 weeks and after 13 weeks
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Points on a scale (0-100, higher = better); participants ≥18 years
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Baseline (1 week after inclusion), after 9 weeks and after 13 weeks
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Health-Related Quality of Life - Mental Component Summary (SF-36 MCS, Adults)
Lasso di tempo: Baseline (1 week after inclusion), after 9 weeks and after 13 weeks
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Points on a scale (0-100, higher = better); participants ≥18 years
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Baseline (1 week after inclusion), after 9 weeks and after 13 weeks
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Health-Related Quality of Life - Physical Health Summary Score (Minors, PedsQL)
Lasso di tempo: Baseline (1 week after inclusion), after 9 weeks and after 13 weeks
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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.
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Baseline (1 week after inclusion), after 9 weeks and after 13 weeks
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Health-Related Quality of Life - Psychosocial Health Summary Score (Minors, PedsQL)
Lasso di tempo: Baseline (1 week after inclusion), after 9 weeks and after 13 weeks
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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.
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Baseline (1 week after inclusion), after 9 weeks and after 13 weeks
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Cancer-Related Fatigue
Lasso di tempo: Baseline (1 week after inclusion), after 9 weeks and after 13 weeks
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Assessed via the Multidimensional Fatigue Inventory (MFI-20), comprising 5 subscales (General Fatigue, Physical Fatigue, Reduced Activity, Reduced Motivation, Mental Fatigue)
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Baseline (1 week after inclusion), after 9 weeks and after 13 weeks
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Limb Function (Extremity-Specific)
Lasso di tempo: Baseline (1 week after inclusion), after 9 weeks and after 13 weeks
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Lower/upper extremity function assessed via the Toronto Extremity Salvage Score (TESS)
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Baseline (1 week after inclusion), after 9 weeks and after 13 weeks
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Orthopedic Long-Term Complications
Lasso di tempo: Baseline (1 week after inclusion), after 9 weeks and after 13 weeks
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Incidence of orthopedic complications (e.g., prosthesis-related issues, need for re-operation) recorded during follow-up
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Baseline (1 week after inclusion), after 9 weeks and after 13 weeks
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Self-Reported Physical Activity (SQUASH)
Lasso di tempo: Baseline (1 week after inclusion), after 9 weeks and after 13 weeks
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Subjectively assessed physical activity level, measured via the Short QUestionnaire to ASsess Health-enhancing physical activity (SQUASH), German version
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Baseline (1 week after inclusion), after 9 weeks and after 13 weeks
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Collaboratori e investigatori
Sponsor
Sponsor
Investigatori
Investigatori
- Investigatore principale: Miriam Götte, Dr. rer. medic., University Hospital, Essen
- Investigatore principale: Ina Elisa Kirchberg, Dr. med., University Hospital, Essen
- Investigatore principale: Uta Dirksen, Univ.-Prof. Dr. med., University Hospital, Essen
Studiare le date dei record
Studia le date principali
Inizio studio (Stimato)
Inizio studio
Completamento primario (Stimato)
Completamento primario
Completamento dello studio (Stimato)
Completamento dello studio
Date di iscrizione allo studio
Primo inviato
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Primo Inserito
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento pubblicato
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
Altri numeri di identificazione dello studio
- Sport ist Herzenssache
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