Adherence to a Personalized Home Exercise Program in Patients With Bone Tumor Undergoing Lower Extremity Salvage Surgery

NCT05779670 | Recruiting

• 1 other identifier: 5001
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this study is to describe adherence to a personalised home exercise program in patients undergoing resection and reconstruction of lower limb for bone tumor and neoadjuvant chemotherapy treatment in the first six months after surgery intervention and investigate possible prognostic factors.

Conditions

Chondrosarcoma; Bone Tumor; Osteosarcoma; Ewing Sarcoma

Keywords

rehabilitation; home based exercise; bone tumor

Outcome Measures

Primary Outcomes (1)

• adherence to the rehabilitation program

  every day the patient will record the exercise execution/not-execution

  everyday from baseline at 6 months

Secondary Outcomes (3)

• TESS

  at 3 months and at 6 months

• TUG

  at 3 months and at 6 months

• patient satisfaction

  at 3 months and at 6 months

Eligibility Criteria

• Age: 12 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Will be recruited consecutively all patients with bone cancer undergoing resection and reconstruction of the lower limb at the "Orthopedic and Traumatological Clinic III to prevalent oncological address" of the Rizzoli Orthopaedic Institute in the period from 01/2023 to 12/2024 and subsequently to the "SC Osteoncologia, sarcomas of bone and soft tissues, and innovative therapies of the same hospital for the continuation of treatment" in the next six months after surgery.

You may qualify if:

• patients aged 12 years with bone tumor undergoing surgery (resection and reconstruction of the lower limb) and in adjuvant treatment
• patients under physiotherapy treatment

You may not qualify if:

• patients with difficulties in understanding the Italian language
• patients not using digital services

Sponsors & Collaborators

• Istituto Ortopedico Rizzoli: lead

Study Sites (1)

Istituto Ortopedico Rizzoli

Bologna, 40136, Italy

RECRUITING

Related Publications (27)

• Cramp F, Byron-Daniel J. Exercise for the management of cancer-related fatigue in adults. Cochrane Database Syst Rev. 2012 Nov 14;11(11):CD006145. doi: 10.1002/14651858.CD006145.pub3.

  PMID: 23152233 BACKGROUND

• van Weert E, Hoekstra-Weebers JE, May AM, Korstjens I, Ros WJ, van der Schans CP. The development of an evidence-based physical self-management rehabilitation programme for cancer survivors. Patient Educ Couns. 2008 May;71(2):169-90. doi: 10.1016/j.pec.2007.11.027. Epub 2008 Feb 5.

  PMID: 18255249 BACKGROUND

• Mishra SI, Scherer RW, Snyder C, Geigle PM, Berlanstein DR, Topaloglu O. Exercise interventions on health-related quality of life for people with cancer during active treatment. Cochrane Database Syst Rev. 2012 Aug 15;2012(8):CD008465. doi: 10.1002/14651858.CD008465.pub2.

  PMID: 22895974 BACKGROUND

• Jones LW, Liang Y, Pituskin EN, Battaglini CL, Scott JM, Hornsby WE, Haykowsky M. Effect of exercise training on peak oxygen consumption in patients with cancer: a meta-analysis. Oncologist. 2011;16(1):112-20. doi: 10.1634/theoncologist.2010-0197. Epub 2011 Jan 6.

  PMID: 21212429 BACKGROUND

• Bodenheimer T, Lorig K, Holman H, Grumbach K. Patient self-management of chronic disease in primary care. JAMA. 2002 Nov 20;288(19):2469-75. doi: 10.1001/jama.288.19.2469.

  PMID: 12435261 BACKGROUND

• Mock V, Dow KH, Meares CJ, Grimm PM, Dienemann JA, Haisfield-Wolfe ME, Quitasol W, Mitchell S, Chakravarthy A, Gage I. Effects of exercise on fatigue, physical functioning, and emotional distress during radiation therapy for breast cancer. Oncol Nurs Forum. 1997 Jul;24(6):991-1000.

  PMID: 9243585 BACKGROUND

• Schwartz AL. Daily fatigue patterns and effect of exercise in women with breast cancer. Cancer Pract. 2000 Jan-Feb;8(1):16-24. doi: 10.1046/j.1523-5394.2000.81003.x.

  PMID: 10732535 BACKGROUND

• Schwartz AL. Exercise and weight gain in breast cancer patients receiving chemotherapy. Cancer Pract. 2000 Sep-Oct;8(5):231-7. doi: 10.1046/j.1523-5394.2000.85007.x.

  PMID: 11898235 BACKGROUND

• Segar ML, Katch VL, Roth RS, Garcia AW, Portner TI, Glickman SG, Haslanger S, Wilkins EG. The effect of aerobic exercise on self-esteem and depressive and anxiety symptoms among breast cancer survivors. Oncol Nurs Forum. 1998 Jan-Feb;25(1):107-13.

  PMID: 9460778 BACKGROUND

• Pickett M, Mock V, Ropka ME, Cameron L, Coleman M, Podewils L. Adherence to moderate-intensity exercise during breast cancer therapy. Cancer Pract. 2002 Nov-Dec;10(6):284-92. doi: 10.1046/j.1523-5394.2002.106006.x.

  PMID: 12406050 BACKGROUND

• Markes M, Brockow T, Resch KL. Exercise for women receiving adjuvant therapy for breast cancer. Cochrane Database Syst Rev. 2006 Oct 18;(4):CD005001. doi: 10.1002/14651858.CD005001.pub2.

  PMID: 17054230 BACKGROUND

• Kampshoff CS, Jansen F, van Mechelen W, May AM, Brug J, Chinapaw MJ, Buffart LM. Determinants of exercise adherence and maintenance among cancer survivors: a systematic review. Int J Behav Nutr Phys Act. 2014 Jul 2;11:80. doi: 10.1186/1479-5868-11-80.

  PMID: 24989069 BACKGROUND

• American College of Sports Medicine Position Stand. The recommended quantity and quality of exercise for developing and maintaining cardiorespiratory and muscular fitness, and flexibility in healthy adults. Med Sci Sports Exerc. 1998 Jun;30(6):975-91. doi: 10.1097/00005768-199806000-00032.

  PMID: 9624661 BACKGROUND

• Lund LW, Ammitzboll G, Hansen DG, Andersen EAW, Dalton SO. Adherence to a long-term progressive resistance training program, combining supervised and home-based exercise for breast cancer patients during adjuvant treatment. Acta Oncol. 2019 May;58(5):650-657. doi: 10.1080/0284186X.2018.1560497. Epub 2019 Jan 30.

  PMID: 30698050 BACKGROUND

• Kim JY, Lee MK, Lee DH, Kang DW, Min JH, Lee JW, Chu SH, Cho MS, Kim NK, Jeon JY. Effects of a 12-week home-based exercise program on quality of life, psychological health, and the level of physical activity in colorectal cancer survivors: a randomized controlled trial. Support Care Cancer. 2019 Aug;27(8):2933-2940. doi: 10.1007/s00520-018-4588-0. Epub 2018 Dec 18.

  PMID: 30564936 BACKGROUND

• Nyrop KA, Deal AM, Choi SK, Wagoner CW, Lee JT, Wood WA, Anders C, Carey LA, Dees EC, Jolly TA, Reeder-Hayes KE, Muss HB. Measuring and understanding adherence in a home-based exercise intervention during chemotherapy for early breast cancer. Breast Cancer Res Treat. 2018 Feb;168(1):43-55. doi: 10.1007/s10549-017-4565-1. Epub 2017 Nov 9.

  PMID: 29124455 BACKGROUND

• Wang YQ, Liu X, Yin YY, Ma RC, Yang Z, Cao HP, Xie J. Effects of Home-Based Exercise Training for Patients With Lung Cancer. Oncol Nurs Forum. 2019 Jul 1;46(4):E119-E134. doi: 10.1188/19.ONF.E119-E134.

  PMID: 31225844 BACKGROUND

• van Waart H, Buffart LM, Stuiver MM, van Harten WH, Sonke GS, Aaronson NK. Adherence to and satisfaction with low-intensity physical activity and supervised moderate-high intensity exercise during chemotherapy for breast cancer. Support Care Cancer. 2020 May;28(5):2115-2126. doi: 10.1007/s00520-019-05019-1. Epub 2019 Aug 8.

  PMID: 31396745 BACKGROUND

• Hiraoui M, Al-Haddabi B, Gmada N, Doutrellot PL, Mezlini A, Ahmaidi S. Effects of combined supervised intermittent aerobic, muscle strength and home-based walking training programs on cardiorespiratory responses in women with breast cancer. Bull Cancer. 2019 Jun;106(6):527-537. doi: 10.1016/j.bulcan.2019.03.014. Epub 2019 May 20.

  PMID: 31122656 BACKGROUND

• Indelicato DJ, Keole SR, Shahlaee AH, Shi W, Morris CG, Gibbs CP Jr, Scarborough MT, Marcus RB Jr. Long-term clinical and functional outcomes after treatment for localized Ewing's tumor of the lower extremity. Int J Radiat Oncol Biol Phys. 2008 Feb 1;70(2):501-9. doi: 10.1016/j.ijrobp.2007.06.032. Epub 2007 Sep 12.

  PMID: 17855013 BACKGROUND

• Mavrogenis AF, Abati CN, Romagnoli C, Ruggieri P. Similar survival but better function for patients after limb salvage versus amputation for distal tibia osteosarcoma. Clin Orthop Relat Res. 2012 Jun;470(6):1735-48. doi: 10.1007/s11999-011-2238-7. Epub 2012 Jan 24.

  PMID: 22270466 BACKGROUND

• Morri M, Raffa D, Barbieri M, Ferrari S, Mariani E, Vigna D. Compliance and satisfaction with intensive physiotherapy treatment during chemotherapy in patients with bone tumours and evaluation of related prognostic factors: An observational study. Eur J Cancer Care (Engl). 2018 Nov;27(6):e12916. doi: 10.1111/ecc.12916. Epub 2018 Sep 27.

  PMID: 30260524 BACKGROUND

• Carty CP, Bennett MB, Dickinson IC, Steadman P. Assessment of kinematic and kinetic patterns following limb salvage procedures for bone sarcoma. Gait Posture. 2009 Nov;30(4):547-51. doi: 10.1016/j.gaitpost.2009.08.234. Epub 2009 Sep 10.

  PMID: 19747830 BACKGROUND

• de Visser E, Deckers JA, Veth RP, Schreuder HW, Mulder TW, Duysens J. Deterioration of balance control after limb-saving surgery. Am J Phys Med Rehabil. 2001 May;80(5):358-65. doi: 10.1097/00002060-200105000-00007.

  PMID: 11327558 BACKGROUND

• Rossi L, Boffano M, Comandone A, Ferro A, Grignani G, Linari A, Pellegrino P, Piana R, Ratto N, Davis AM. Validation process of Toronto Exremity Salvage Score in Italian: A quality of life measure for patients with extremity bone and soft tissue tumors. J Surg Oncol. 2020 Mar;121(4):630-637. doi: 10.1002/jso.25849. Epub 2020 Jan 19.

  PMID: 31957034 BACKGROUND

• Podsiadlo D, Richardson S. The timed "Up & Go": a test of basic functional mobility for frail elderly persons. J Am Geriatr Soc. 1991 Feb;39(2):142-8. doi: 10.1111/j.1532-5415.1991.tb01616.x.

  PMID: 1991946 BACKGROUND

• Bahcaci U, Demirbuken I. Effects of chemotherapy process on postural balance control in patients with breast cancer. Indian J Cancer. 2019 Jan-Mar;56(1):50-54. doi: 10.4103/ijc.IJC_47_18.

  PMID: 30950445 BACKGROUND

MeSH Terms

Conditions

Osteosarcoma; Sarcoma, Ewing; Chondrosarcoma; Bone Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• alida abbruzzese

  ufficio ricerca professioni sanitarie

  PRINCIPAL INVESTIGATOR

Central Study Contacts

alida abbruzzese

CONTACT

+390516366354; alida.abbruzzese@ior.it

matilde meneghini

CONTACT

+390516366354; matilde.meneghini@ior.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2023
• First Posted: March 22, 2023
• Study Start: January 1, 2023
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: February 3, 2026

Record last verified: 2026-02

Locations

IT (1)