"Exercise Intervention to Increase Physical Activity in Young Sarcoma Survivors (Sport Ist Herzenssache)"
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age15+
SponsorUniversität Duisburg-Essen
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Individualized Exercise Program
BehavioralAn 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.
Treatment groups
46 Participants
are divided into 2 treatment groupsGroup A: Intervention Group (Exercise + Smartwatch)Experimental treatment 1 intervention
Group B: Control Group (Smartwatch Only)No intervention 0 interventions
Trial outcomes
Primary outcomes
1
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 weeks2
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 weeks3
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 weeks4
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 weeksSecondary outcomes
1
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 weeks2
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 weeks3
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 weeks4
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 weeksLocations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: