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

NCT ID: NCT05779670

Last Updated: 2025-03-26

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 50 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-01-01
• Study Completion Date: 2025-12-31

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.

Detailed Description

In cancer patients undergoing adjuvant therapies, rehabilitation plays an important role in reducing the side effects of chemotherapy treatment by promoting cardiorespiratory function, reducing fatigue and improving quality of life. Physiotherapy treatment, generally, includes physical training programs administered in many ways, not yet well standardized. With the aim of seeking an empowerment of the patient and his active participation, more and more exercise programs are used that the patient is able to manage independently. Adherence to and compliance with such exercise programs is extremely variable in literature and can range from 52% to 89%. A high level of adhesion is a well-known challenge and a fundamental prerequisite for achieving the benefits of physical activity. Home exercise programs to be performed in complete autonomy have been proposed in patients with different types of cancer, while for patients with bone tumor, to date there are no experiences. In this group of patients the role of physiotherapy is significant not only to counteract the adverse effects of chemotherapy treatment but also to promote the recovery of patients following the important resection and reconstruction interventions. In this type of patient, a high adherence to the physiotherapy treatment started already during the periods of hospitalization for the administration of antiblastic treatment.

Data will be collected from all patients treated consecutively over two years according to the defined inclusion criteria. Given the rarity of oncologic pathology of the musculoskeletal system and the limited number of patients of 27 found to meet the inclusion criteria in the year 2021, it is assumed that data will be collected from a sample of 50 patients.

The variables collected will be: age, sex, BMI, smoking, physical activity level, diagnosis, metastasis at diagnosis, type of surgery, chemotherapy treatment.

Data will be described by mean and standard deviation or median and interquartile range values according to the nature of the data and frequency and percentage for dichotomous variables

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

Osteosarcoma; Ewing Sarcoma; Chondrosarcoma; Bone Tumor

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Istituto Ortopedico Rizzoli

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

alida abbruzzese

Role: PRINCIPAL_INVESTIGATOR

ufficio ricerca professioni sanitarie

Locations

Istituto Ortopedico Rizzoli

Bologna, , Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

alida abbruzzese

Role: CONTACT

alida.abbruzzese@ior.it

+390516366354

matilde meneghini

Role: CONTACT

matilde.meneghini@ior.it

+390516366354

Facility Contacts

alida abbruzzese

Role: primary

alida.abbruzzese@ior.it

References

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.

Reference Type: BACKGROUND

PMID: 23152233 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 18255249 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 22895974 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 21212429 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 12435261 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 9243585 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 10732535 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 11898235 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 9460778 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 12406050 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 17054230 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 24989069 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 9624661 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 30698050 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 30564936 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 29124455 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 31225844 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 31396745 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 31122656 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 17855013 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 22270466 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 30260524 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 19747830 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 11327558 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 31957034 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 1991946 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 30950445 (View on PubMed)

Other Identifiers

5001

Identifier Type: -

Identifier Source: org_study_id