Exercise Rehabilitation to Improve Long-term Outcomes in Sarcoma Survivors.

NCT07893041 | Completed

• 2 other identifiers: RA/4/1/6034Emma Pauley Research Grant
• Study Type: interventional
• Target: 25
• Locations: 0 countries
• Sites: N/A

Brief 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. 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. 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.

Conditions

Sarcoma; Sarcoma of Bone and Connective Tissue; Sarcoma of Soft Tissue; Sarcoma of Bone

Keywords

rehabilitation; lower limb sarcoma; cancer survivorship; exercise rehabilitation,; physical function; exercise physiology

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline (second of two assessments), 8 weeks, and 16 weeks

Secondary Outcomes (5)

• six-minute walk test distance

  Baseline (second assessment), 8 weeks, 16 weeks

• lower limb isokinetic strength (peak torque)

  Baseline (second assessment), 8 weeks, 16 weeks

• lower limb joint range of motion

  Baseline (second assessment), 8 weeks, 16 weeks

• Toronto Extremity Salvage Score, lower limb

  Baseline (second assessment), 8 weeks, 16 weeks

• SF-36 physical and mental component summary scores

  Baseline (second assessment), 8 weeks, 16 weeks

Study Arms (1)

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.

Behavioral: Supervised Exercise Rehabilitation Program

Interventions

Supervised Exercise Rehabilitation Program BEHAVIORAL

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.

Supervised Exercise Rehabilitation

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Curtin University: lead

MeSH Terms

Conditions

Sarcoma; Osteosarcoma

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Bone Tissue; Neoplasms, Connective Tissue

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: October 19, 2026
• First Posted: October 23, 2026
• Study Start: January 1, 2014
• Primary Completion: May 30, 2015
• Study Completion: October 30, 2015
• Last Updated: October 23, 2026

Record last verified: 2026-10

Data Sharing

• IPD Sharing: Will not share