"Exercise Intervention to Increase Physical Activity in Young Sarcoma Survivors (Sport Ist Herzenssache)"

NCT07729059 | Not Yet Recruiting

• 1 other identifier: Sport ist Herzenssache
• Study Type: interventional
• Target: 46
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

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; Limb Function

Outcome Measures

Primary Outcomes (11)

• 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 Outcomes (8)

• Health-Related Quality of Life - Physical Component Summary (SF-36 PCS, Adults)

  Baseline (1 week after inclusion), after 9 weeks and after 13 weeks

• Health-Related Quality of Life - Mental Component Summary (SF-36 MCS, Adults)

  Baseline (1 week after inclusion), after 9 weeks and after 13 weeks

• Health-Related Quality of Life - Physical Health Summary Score (Minors, PedsQL)

  Baseline (1 week after inclusion), after 9 weeks and after 13 weeks

• Health-Related Quality of Life - Psychosocial Health Summary Score (Minors, PedsQL)

  Baseline (1 week after inclusion), after 9 weeks and after 13 weeks

• Cancer-Related Fatigue

  Baseline (1 week after inclusion), after 9 weeks and after 13 weeks

Study Arms (2)

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.

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.

Interventions

Individualized Exercise Program BEHAVIORAL

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

Intervention Group (Exercise + Smartwatch)

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universität Duisburg-Essen: lead

MeSH Terms

Conditions

Bone Neoplasms; Sarcoma; Motor Activity

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Bone Diseases; Musculoskeletal Diseases; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Behavior

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ina Elisa Kirchberg, Dr. med.

CONTACT

+49 201 723 8084; InaElisa.Kirchberg@uk-essen.de

Miriam Götte, Dr. rer. medic.

CONTACT

+49 201 723 8083; miriam.goette@uk-essen.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PD Dr. rer. medic.

Study Record Dates

• First Submitted: July 16, 2026
• First Posted: July 27, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): July 31, 2028
• Study Completion (Estimated): July 31, 2028
• Last Updated: July 27, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share