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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05779670
Other study ID # 5001
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 1, 2023
Est. completion date December 31, 2025

Study information

Verified date March 2024
Source Istituto Ortopedico Rizzoli
Contact alida abbruzzese
Phone +390516366354
Email alida.abbruzzese@ior.it
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 50
Est. completion date December 31, 2025
Est. primary completion date December 31, 2025
Accepts healthy volunteers No
Gender All
Age group 12 Years to 90 Years
Eligibility 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

Study Design


Locations

Country Name City State
Italy Istituto Ortopedico Rizzoli Bologna

Sponsors (1)

Lead Sponsor Collaborator
Istituto Ortopedico Rizzoli

Country where clinical trial is conducted

Italy, 

References & Publications (27)

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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. — View Citation

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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. Erratum In: Oncologist. 2011;16(2):260. — View Citation

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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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Erratum In: Breast Cancer Res Treat. 2019 Jan;173(1):245. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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* Note: There are 27 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary adherence to the rehabilitation program every day the patient will record the exercise execution/not-execution everyday from baseline at 6 months
Secondary TESS The TESS is a self-administered questionnaire evaluating possible limitations in physical activity. A total of 30 questions are included in the TESS, and the degree of disability is rated from 0 (complete disability) to 5 (no functional impairment) in each item. Similar to MSTS for lower extremity, the final TESS score is converted to a score ranging from 0 to 100 points. If a question in TESS score does not apply to the patient, the last can respond "not applicable." at 3 months and at 6 months
Secondary TUG Timed up and go is a simple test to measure a person's mobility level and requires static and dynamic balancing skills. It consists of measuring how many seconds it takes the patient to get up from the chair, walk a distance of 3 meters, turn around, return to the chair and sit down again. at 3 months and at 6 months
Secondary patient satisfaction will be investigated with a questionnaire consisting of a likert scale of 4 questions with score from 0 (not at all satisfied) to 5 (completely satisfied). at 3 months and at 6 months
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