SarcomaNCT07893041
Exercise Rehabilitation to Improve Long-term Outcomes in Sarcoma Survivors.
A study testing Supervised Exercise Rehabilitation Program in people with Sarcoma and Sarcoma of Bone and Connective Tissue, run by Curtin University.
Trial summary
People who have had a sarcoma removed from the leg often live with weak muscles, stiff joints, and trouble walking. These problems can last for years. Formal medical follow-up usually ends about five years after treatment. Few studies have tested exercise at this stage. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Sarcoma, Sarcoma of Bone and Connective Tissue, Sarcoma of Soft Tissue
- What is being tested?
- Supervised Exercise Rehabilitation Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2014to 30 Oct 2015
- Phase
- Interventional
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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- At least 5 years post treatment for sarcoma involving wide resection surgery on the lower limb
- Aged 18 to 70 years
- Male or female
- Lives in the Perth metropolitan area
- Provided voluntary, written informed consent, including permission to publish de-identified data
- Capable of completing an exercise-based program
Who cannot join
- Currently engaged in a formal rehabilitation program at another institution
- Estimated life expectancy of less than 1 year
- Concurrent orthopaedic condition unrelated to the sarcoma treatment
- Cognitive disturbance, serious psychopathology or emotional instability that may hinder participation
- Unable to speak, read and understand English well enough to complete assessments and questionnaires
- Severe cardiovascular disease or other life-threatening illness
About this study
Official title: A MULTIDISCIPLINARY TEAM APPROACH TO IMPROVING LONG TERM OUTCOMES IN SARCOMA SURVIVORS
People who have had a sarcoma removed from the leg often live with weak muscles, stiff joints, and trouble walking. These problems can last for years. Formal medical follow-up usually ends about five years after treatment. Few studies have tested exercise at this stage.
This study tested an 8-week supervised exercise program. Participants were adults aged 18 to 67 who were at least 5 years past limb-sparing (wide resection) surgery for a leg sarcoma. They attended a clinic in Perth, Western Australia, twice a week for one hour. The program built leg strength, joint movement, balance, walking, and fitness. It progressed through three phases and was matched to each person's surgery and ability.
Read more
All participants received the same program type. There was no comparison group. Each person was tested twice before starting to confirm stable function. Testing was repeated at the end of the 8 weeks. It was repeated again 8 weeks later, after a period with no supervised exercise.
The main outcome was high-level mobility, measured by the High-level Mobility Assessment Tool (HiMAT). This tool scores walking, running, hopping, and stair climbing. Other outcomes were six-minute walk distance, leg strength, joint range of motion, and self-reported physical function and quality of life (TESS and SF-36 questionnaires).
The study aimed to learn two things. First, whether exercise improves strength and mobility years after sarcoma surgery. Second, whether those gains last after supervision stops.
- Being tested
- Supervised Exercise Rehabilitation Program
- Keywords
- rehabilitation, lower limb sarcoma, cancer survivorship, exercise rehabilitation,, physical function, exercise physiology
- Medical subject headings
- Sarcoma, Osteosarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supervised Exercise Rehabilitation ProgramBehavioural
Behavioral. An 8-week, fully supervised, individualised exercise program for adults at least 5 years after wide resection for lower limb sarcoma. Sessions ran twice weekly for 1 hour (16 sessions), one-to-one, adjusted to each person's resection and ability. Resistance, aerobic, range of motion, balance and gait training progressed through three phases with achievement criteria.
Phase 1 (weeks 1-2): range of motion, isolated muscle activation, hydrotherapy gait re-education, home exercises.
Phase 2 (weeks 2-4): weighted leg flexion, hip abduction and adduction, closed-chain exercises, balance training, mirror gait retraining, 10 minutes continuous aerobic exercise at about 50% maximum heart rate.
Phase 3 (weeks 4-8): squats, lunges, single-leg balance on uneven surfaces, multi-joint tasks, aerobic exercise at 60-70% maximum heart rate.
No supervised exercise followed from weeks 8 to 16.
| Study group | Role | What they receive |
|---|---|---|
| Supervised Exercise Rehabilitation | Experimental | Adults at least 5 years after wide resection surgery for lower limb sarcoma. All participants received the 8-week, fully supervised exercise rehabilitation program described under Interventions. They attended a clinic in Perth, Western Australia, twice weekly for 1 hour. The program was individualised to each person's surgery and ability. Participants were assessed twice at baseline, at 8 weeks, and at 16 weeks, after 8 weeks without supervised exercise. Receives: Behavioral: Supervised Exercise Rehabilitation Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
High-level Mobility Assessment Tool, HiMAT
The HiMAT measures high-level walking-based mobility across 13 timed or scored items: walking forwards and backwards, walking on toes, stepping over an obstacle, running, skipping, hopping, bounding on each leg, and ascending and descending stairs. Scores sum to a total from 0 to 54. Higher scores indicate better mobility. The primary outcome is the change in total score from baseline to the end of the 8-week supervised exercise program, and the retention of that change at 16 weeks, after 8 weeks without supervised exercise. Baseline is the second of two baseline assessments, taken one week apart to confirm stability. A 4-point change is considered clinically meaningful.
Measured: Baseline (second of two assessments), 8 weeks, and 16 weeks
Secondary outcomes (5)
six-minute walk test distance
Participants walked back and forth between two points 50 m apart for 6 minutes. They covered as much distance as they could safely manage. The tester gave standardised phrases and no encouragement. Total distance in metres was recorded, along with pain in the affected limb and breathlessness at the end. Higher distance indicates better walking capacity. A change of 50 m is considered clinically meaningful.
Measured: Baseline (second assessment), 8 weeks, 16 weeks
lower limb isokinetic strength (peak torque)
Knee extension and flexion peak torque measured bilaterally on an isokinetic dynamometer at 60 degrees per second, after warm-up repetitions. Values are normalised to body weight (Nm/kg). Hip abduction, adduction and flexion strength were also assessed by three-repetition maximum. Higher values indicate greater strength.
Measured: Baseline (second assessment), 8 weeks, 16 weeks
lower limb joint range of motion
Active range of motion in degrees, measured with a goniometer or bubble inclinometer on both limbs. Joints: hip flexion and extension, knee flexion and extension, ankle dorsiflexion and plantar flexion.
Measured: Baseline (second assessment), 8 weeks, 16 weeks
Toronto Extremity Salvage Score, lower limb
The 32-item lower limb version of the TESS, completed unassisted. Scores range from 0 to 100. Higher scores indicate better function
Measured: Baseline (second assessment), 8 weeks, 16 weeks
SF-36 physical and mental component summary scores
The 36-item Short Form Health Survey, completed unassisted. Eight domains combine into a physical component summary (PCS) and a mental component summary (MCS). Higher scores indicate better perceived health.
Measured: Baseline (second assessment), 8 weeks, 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2026
- Study start1 Jan 2014
- Primary completion30 May 2015
- Study completion30 Oct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Curtin University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Claire Munsie, Curtin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07893041
- Sponsor's protocol ID
- RA/4/1/6034
- Other IDs
- Emma Pauley Research Grant
- Status last verified
- Oct 2026
- First submitted
- 19 Oct 2026
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No