NCT05310539

Brief Summary

After "wedge resection" surgery, the physiotherapy programs proposed in the literature are heterogeneous and there are few data on the outcomes of such treatments in an oncological population for bone cancer. The aim of the study is to describe the early rehabilitation process after wedge resection surgery secondary to bone tumor pulmonary mestasasis, highlightining the possible functional recovery in the short and medium term after surgery and indentifying the possible prognostic factors.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 8, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 14, 2022

Completed
22 days until next milestone

First Posted

Study publicly available on registry

April 5, 2022

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 8, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 8, 2024

Completed
Last Updated

February 18, 2025

Status Verified

February 1, 2025

Enrollment Period

2 years

First QC Date

March 14, 2022

Last Update Submit

February 17, 2025

Conditions

Keywords

pulmonary rehabilitationwedge resectionearly recovery

Outcome Measures

Primary Outcomes (1)

  • 1 minute sit to stand (Sixth day after surgery)

    The test requires the person to stand up from a chair, without the help of the arms, fully extending their knees, and sit down the greatest number of times in the time of one minute.

    Sixth day after surgery

Secondary Outcomes (6)

  • 1 minute sit to stand (daily)

    every day after surgery up to 7 day; at 3, 6 and 12 months after surgery.

  • pain intensity

    every day after surgery up to 7 day, twice a day

  • vital capacity (ml)

    every day after surgery up to 7 day, twice a day

  • heart rate (bpm)

    once a day, before and after 1 minute sit to stand test, up to 7 day

  • peripheral oxygen saturation (SpO2 %)

    once a day, before and after 1 minute sit to stand test, up to 7 day

  • +1 more secondary outcomes

Interventions

To assess the early recovery will be used 1 minute sit to stand, Numeric Rating scale to assess pain, incentive spirometer to assess vital capacity, Borg modified scale to assess dyspnea.

Eligibility Criteria

Age12 Years+
Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

all patients admitted to the ward with a diagnosis of pulmonary metastases from bone cancer will be enrolled consecutively for the study.

You may qualify if:

  • over 12 years of age
  • ablative thoracic surgery for metastases localized to the lung and / or chest wall for primary bone cancer
  • must be able to perform the "one minute sit-to-stand" test in the preoperative physiotherapy evaluation

You may not qualify if:

  • ablative thoracic surgery for a diagnosis DIFFERENT FROM that of lung metastases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istituto Ortopedico Rizzoli

Bologna, Emilia-Romagna, 40136, Italy

Location

Related Publications (12)

  • Vijayamurugan N, Bakhshi S. Review of management issues in relapsed osteosarcoma. Expert Rev Anticancer Ther. 2014 Feb;14(2):151-61. doi: 10.1586/14737140.2014.863453. Epub 2013 Nov 26.

    PMID: 24308680BACKGROUND
  • Mori S, Shibazaki T, Noda Y, Kato D, Nakada T, Asano H, Matsudaira H, Ohtsuka T. Recovery of pulmonary function after lung wedge resection. J Thorac Dis. 2019 Sep;11(9):3738-3745. doi: 10.21037/jtd.2019.09.32.

    PMID: 31656646BACKGROUND
  • Bohannon RW, Crouch R. 1-Minute Sit-to-Stand Test: SYSTEMATIC REVIEW OF PROCEDURES, PERFORMANCE, AND CLINIMETRIC PROPERTIES. J Cardiopulm Rehabil Prev. 2019 Jan;39(1):2-8. doi: 10.1097/HCR.0000000000000336.

    PMID: 30489442BACKGROUND
  • Vaidya T, de Bisschop C, Beaumont M, Ouksel H, Jean V, Dessables F, Chambellan A. Is the 1-minute sit-to-stand test a good tool for the evaluation of the impact of pulmonary rehabilitation? Determination of the minimal important difference in COPD. Int J Chron Obstruct Pulmon Dis. 2016 Oct 19;11:2609-2616. doi: 10.2147/COPD.S115439. eCollection 2016.

    PMID: 27799759BACKGROUND
  • Tremblay Labrecque PF, Harvey J, Nadreau E, Maltais F, Dion G, Saey D. Validation and Cardiorespiratory Response of the 1-Min Sit-to-Stand Test in Interstitial Lung Disease. Med Sci Sports Exerc. 2020 Dec;52(12):2508-2514. doi: 10.1249/MSS.0000000000002423.

    PMID: 32555023BACKGROUND
  • Kohlbrenner D, Benden C, Radtke T. The 1-Minute Sit-to-Stand Test in Lung Transplant Candidates: An Alternative to the 6-Minute Walk Test. Respir Care. 2020 Apr;65(4):437-443. doi: 10.4187/respcare.07124. Epub 2019 Oct 22.

    PMID: 31641072BACKGROUND
  • Tarrant BJ, Robinson R, Le Maitre C, Poulsen M, Corbett M, Snell G, Thompson BR, Button BM, Holland AE. The Utility of the Sit-to-Stand Test for Inpatients in the Acute Hospital Setting After Lung Transplantation. Phys Ther. 2020 Jul 19;100(7):1217-1228. doi: 10.1093/ptj/pzaa057.

    PMID: 32280975BACKGROUND
  • Bijur PE, Latimer CT, Gallagher EJ. Validation of a verbally administered numerical rating scale of acute pain for use in the emergency department. Acad Emerg Med. 2003 Apr;10(4):390-2. doi: 10.1111/j.1553-2712.2003.tb01355.x.

    PMID: 12670856BACKGROUND
  • Wyser C, Stulz P, Soler M, Tamm M, Muller-Brand J, Habicht J, Perruchoud AP, Bolliger CT. Prospective evaluation of an algorithm for the functional assessment of lung resection candidates. Am J Respir Crit Care Med. 1999 May;159(5 Pt 1):1450-6. doi: 10.1164/ajrccm.159.5.9809107.

    PMID: 10228110BACKGROUND
  • Weiner P, Man A, Weiner M, Rabner M, Waizman J, Magadle R, Zamir D, Greiff Y. The effect of incentive spirometry and inspiratory muscle training on pulmonary function after lung resection. J Thorac Cardiovasc Surg. 1997 Mar;113(3):552-7. doi: 10.1016/S0022-5223(97)70370-2.

    PMID: 9081102BACKGROUND
  • Schnapp LM, Cohen NH. Pulse oximetry. Uses and abuses. Chest. 1990 Nov;98(5):1244-50. doi: 10.1378/chest.98.5.1244.

    PMID: 2225973BACKGROUND
  • 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: 31957034BACKGROUND

MeSH Terms

Conditions

Bone Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBone DiseasesMusculoskeletal Diseases

Study Officials

  • marco cotti, pt

    IOR - Istituto Ortopedico Rizzoli

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

March 14, 2022

First Posted

April 5, 2022

Study Start

January 8, 2022

Primary Completion

January 8, 2024

Study Completion

January 8, 2024

Last Updated

February 18, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations