"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.

Study Overview

• Status: Not yet recruiting
• Conditions: Bone Sarcoma; Soft Tissue Sarcoma (STS)
• Intervention / Treatment: Behavioral: Individualized Exercise Program

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 Type: Interventional
• Enrollment (Estimated): 46
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ina Elisa Kirchberg, Dr. med.; Phone Number: +49 201 723 8084; Email: InaElisa.Kirchberg@uk-essen.de
• Study Contact Backup: Name: Miriam Götte, Dr. rer. medic.; Phone Number: +49 201 723 8083; Email: miriam.goette@uk-essen.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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., 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.; Other Names: Structured Home-Based Exercise Intervention; Partially Supervised Training Program; Individualized Physical Activity Program
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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)	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)	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	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)	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	Baseline (1 week after inclusion), after 9 weeks and after 13 weeks
Muscle Strength	Muscle strength measured in Newtons via handheld dynamometry	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)	Baseline (1 week after inclusion), after 9 weeks and after 13 weeks
Left Ventricular Ejection Fraction (LVEF)	Assessed via transthoracic echocardiography, measured in percent (%)	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	Baseline (1 week after inclusion), after 9 weeks and after 13 weeks
QTc Interval	Assessed via 12-lead ECG, measured in milliseconds	Baseline (1 week after inclusion), after 9 weeks and after 13 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Health-Related Quality of Life - Physical Component Summary (SF-36 PCS, Adults)	Points on a scale (0-100, higher = better); participants ≥18 years	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	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.	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.	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)	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)	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	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	Baseline (1 week after inclusion), after 9 weeks and after 13 weeks

Collaborators and Investigators

• Sponsor: Universität Duisburg-Essen
• Investigators: Principal Investigator: Miriam Götte, Dr. rer. medic., University Hospital, Essen; Principal Investigator: Ina Elisa Kirchberg, Dr. med., University Hospital, Essen; Principal Investigator: Uta Dirksen, Univ.-Prof. Dr. med., University Hospital, Essen

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): July 31, 2028
• Study Completion (Estimated): July 31, 2028

Study Registration Dates

• First Submitted: July 16, 2026
• First Submitted That Met QC Criteria: July 22, 2026
• First Posted (Actual): July 27, 2026

Study Record Updates

• Last Update Posted (Actual): July 27, 2026
• Last Update Submitted That Met QC Criteria: July 22, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: Physical Activity; Exercise; Quality of Life; Soft Tissue Sarcoma; Cardiorespiratory Fitness; Cancer Survivorship; Adolescents and Young Adults; Bone Sarcoma; Limb Function
• Additional Relevant MeSH Terms: Bone Diseases; Musculoskeletal Diseases; Neoplasms by Site; Neoplasms; Neoplasms by Histologic Type; Neoplasms, Connective and Soft Tissue; Behavior; Sarcoma; Bone Neoplasms; Motor Activity
• Other Study ID Numbers: Sport ist Herzenssache

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No