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Chrysarobin

The intervention group will receive PT 3 times per week for 60 minutes each session. The therapy sessions will include endurance, strengthening, and stretching exercises.

Exercise time and resistance will be progressed per individual's medical status and per participant's tolerance. All participants will be given a tailored home exercise program (HEP).

Participants will participate in PT 10 weeks prior to surgery and 10-12 weeks after surgery. Subjects will be seen by the physical therapist both when inpatient and outpatient. Patients will not be seen for PT if platelet count is less than 20,000mm3 and/or hemoglobin is less than 8g/dL.

Endurance exercise will consist of ambulating with assistive devices as needed, upper extremity (UE) ergometer, and/or playing the Wii.

Endurance

Strengthening exercises will involve both UE's and LE's. For UE's, bicep curls, triceps curls, shoulder flexion, and/or press-ups from the therapy mat or wheelchair will be included. For the LE's, bridging, long arc quads, hamstring curls, calf raises in standing, single LE squats, and/or dorsiflexion (DF) in supine will be performed on the uninvolved extremity.

Strengthening

Stretching will consist of ankle stretch into DF in supine or long sitting, hamstring stretch in supine with hip flexed to 90 degrees, and trunk extension in sitting.

Stretching

All participants will be given a tailored home exercise program (HEP) including endurance exercises, strengthening, and stretching exercises to be completed on days they do not have PT. If the participants return home, they will be asked to complete the HEP at least 3 days per week. The physical therapist will contact the participant weekly to modify the HEP if necessary and determine compliance.

Home exercise program

Angela M. Corr, PT, DPT

This application proposes a prospective clinical trial to evaluate the impact of adding a focused physical therapy (PT) intervention to the preoperative regimen of individuals diagnosed with a malignancy of the lower extremity (LE). The primary aim will be to determine if individuals diagnosed with a malignancy of the LE can participate in a 10 week preoperative strengthening, stretching, and aerobic exercise regimen.

The intervention group will receive PT 3 times per week for 60 minutes each session. The therapy sessions will include endurance, strengthening, and stretching exercises. Endurance exercises will consist of ambulating with assistive devices as needed, using the upper extremity (UE) ergometer, and/or playing the Wii. Strengthening exercises will involve both UE's and LE's. For UE's, bicep curls, triceps curls, shoulder flexion, and/or press-ups from the therapy mat or wheelchair will be included. For the LE's, bridging, long arc quads, hamstring curls, calf raises in standing, single LE squats, and/or dorsiflexion (DF) in supine will be performed on the uninvolved extremity. Resistance and exercise time will be increased depending upon participant's tolerance. Stretching will consist of ankle stretch into DF in supine or long sitting, hamstring stretch in supine with hip flexed to 90 degrees, and trunk extension in sitting.

PRIMARY OBJECTIVE

To determine if individuals diagnosed with a malignancy of the LE can participate in a 10 week preoperative strengthening, stretching, and aerobic exercise regimen.

Effects of Preoperative Physical Therapy in Patients With Lower Extremity Malignancy

A Pilot Study on the Effects of Preoperative Physical Therapy in Adolescents and Young Adults Diagnosed With a Lower Extremity Malignancy

Determine if individuals diagnosed with a malignancy of the LE can participate in a 10 week preoperative strengthening, stretching, and aerobic exercise regimen. We will consider the study to be feasible if at least 60% of the patients are able to complete at least 50% of their scheduled PT sessions.

Tennessee Physical Therapy Association

St. Jude Children's Research Hospital

Blood and Lymph Conditions

Symptoms and General Pathology

Lymphedema

Breast Neoplasms

Breast Cancer Lymphedema

Breast Diseases

Skin Diseases

Lymphatic Diseases

Postoperative Complications

Group A (Control). Home decongestive exercise regimen + daytime use of a compression sleeve (12 hours per day)

Group B. Decongestive Progressive Resistance Exercise + compression sleeve use during exercise + daytime use of a compression sleeve (12 hours per day)

Group C. Decongestive Progressive Resistance Exercise + Adjustable Compression (AC) garment use during exercise + daytime use of a compression sleeve (12 hours per day).

Participants wear their daytime compression sleeve during the DPRE program.

Compression sleeve, worn during exercise

Participants wear an Adjustable Compression (AC) garment during the DPRE program. Participants will be fitted for an Adjustable Compression garment and instructed in its application by a physical therapist.

Adjustable Compression (AC) garment, worn during exercise

Compression sleeve worn for at least 12 hours per day, seven days a week.

Compression sleeve, daytime wear

Supervised DPRE exercise program, twice a week for 12 weeks. Exercises will be individualized and offered in a group-based format.

After the 12-week intervention, participants will continue the same program (independently) twice weekly for an additional 12 weeks at home or in a community-based fitness center or attend supervised group exercise sessions virtually.

Decongestive Progressive Resistance Exercise program

Participants are provided with a home exercise program that follows the decongestive exercise sequence and instructed to perform the exercise sequence once daily for a 10-15 minute period.

The purpose of this study is to investigate the benefit of combining resistance exercise with use of a compression sleeve on arm lymphedema. In the study, participants will be taught a resistance exercise that follows the decongestive exercise sequence. This program is called "decongestive progressive resistance exercise" (DPRE). To evaluate the benefit from use of a compression garment on the arm. Some participants will wear their usual compression sleeve during exercise and others will use an adjustable compression wrap. The investigators hope to see if this type of combined program is helpful for women with lymphedema. The investigators also want to see if there are benefits from the addition of use of an adjustable compression wrap during exercise over use of a regularly prescribed compression sleeve.

Exercise and Compression for Lymphedema

Decongestive Progressive Resistance Exercise With Advanced Compression for Breast Cancer Related Lymphedema Management (DREAM): A Randomized Control Trial

Lymphedema will be objectively measured using the optoelectronic limb volumeter (perometer).

Bioimpedance analysis (BIA) is specially designed to estimate extracellular fluid volume in the limb. BIA measures the impedance ratio of the affected and unaffected limb and the resulting calculated index provides an estimate of extracellular fluid volume.

Muscle strength will be assessed with the one-repetition maximum (1-RM) method for bench press, leg press, and seated row. The 1-RM is the highest weight that can be lifted once using proper form, a smooth motion and without pain or other symptoms.

The Jamar hydraulic hand dynamometer will be used to measure grip strength.

Shoulder range of motion (ROM) will be measured using plastic goniometer and each arm will be measured separately for flexion, abduction, internal, external rotation, and horizontal abduction.

The Lymphedema Functioning, Disability, and Health (Lymph-ICF) questionnaire consists of 29 questions related to functional impairments, activity limitations, and participation restrictions in patients with upper limb lymphedema.The total score of the Lymph-ICF on the five areas ranges from 0 to 100, with a score of 0 meaning no impact and higher scores indicative of worse function or negative impact.

The Rand Short Form-36 Version 2 (SF-36) questionnaire is comprised of 36 questions that aim to evaluate the following eight models of HRQOL: physical functioning, role limitations due to physical health, bodily pain, general health perceptions, vitality/energy, social functioning, role limitations due to emotional problems, and general mental health.

The Godin leisure-time exercise questionnaire (GLTEQ) will be used to assess the physical activity level. The Godin questionnaire is a self reported measure of the average duration and frequency of strenuous (heart beats rapidly), moderate (not exhausting), and mild activities (minimal effort), resistance training, and flexibility training exercise.

Participants will be asked to record their adherence to their assigned exercise and compression intervention program using a daily diary.The adherence diary will collect details on exercise sessions performed each day, including sets, repetitions, and resistance weight, as well as use of the assigned compression sleeve (i.e. use of the garment during exercises and number of hours per day and days per week the compression sleeve is worn).

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Effects of Preoperative Physical Therapy in Patients With Lower Extremity Malignancy	NCT01674101	Osteosarcoma Ewing's Sarcoma Rhabdomyosarcom... Synovial Sarcom... Malignant Perip... Malignant Fibro... Chondrosarcoma ...	Endurance Strengthening Stretching Home exercise p...	6 Years - 30 Years	St. Jude Children's Research Hospital
Exercise and Compression for Lymphedema	NCT05022823	Breast Cancer R...	Compression sle... Adjustable Comp... Compression sle... Decongestive Pr... Home exercise p...	18 Years -	AHS Cancer Control Alberta
Effects of Preoperative Physical Therapy in Patients With Lower Extremity Malignancy	NCT01674101	Osteosarcoma Ewing's Sarcoma Rhabdomyosarcom... Synovial Sarcom... Malignant Perip... Malignant Fibro... Chondrosarcoma ...	Endurance Strengthening Stretching Home exercise p...	6 Years - 30 Years	St. Jude Children's Research Hospital
Exercise and Compression for Lymphedema	NCT05022823	Breast Cancer R...	Compression sle... Adjustable Comp... Compression sle... Decongestive Pr... Home exercise p...	18 Years -	AHS Cancer Control Alberta

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