Physical Inactivity in Candidates of HSCT

NCT03915210 | Completed

• 1 other identifier: GaziUniversity18
• Study Type: observational
• Target: 94
• Locations: 0 countries
• Sites: N/A

Brief Summary

Decreased number of steps and poorer quality of life are prevalently observed among candidates of hematopoietic stem cell transplantation (HSCT). However, impairments in other aspects of physical activity measurement including energy expenditure, physical activity duration, metabolic equivalents of daily task (METs) and lying down duration are still unknown in candidates based on comparison with healthy individuals, which was therefore aimed to investigate in current study.

Conditions

Hematopoietic Stem Cell Transplantation

Keywords

Energy metabolism; Exercise; respiratory function test; quality of life; leisure activities; hematopoietic stem cell transplantation

Outcome Measures

Primary Outcomes (1)

• Physical activity measurement

  Physical activity levels of all participants were assessed with a metabolic holter device.

  during a total of 48 hours

Secondary Outcomes (2)

• Evaluation of dynamic lung volumes

  5 minutes

• General quality of life assesment: European Organization for Research and Treatment of Cancer QOL Questionnaire (EORTCQOL)

  2 minutes

Study Arms (2)

Candidates of HSCT

Physical activity level using a metabolic holter device, dynamic lung volumes (FEV1, FVC, FEV1/FVC, PEF, FEF25-75%) using a spirometer and quality of life using European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 version 3.0 were objectively evaluated.

Healthy individuals

Physical activity level using a metabolic holter device, dynamic lung volumes (FEV1, FVC, FEV1/FVC, PEF, FEF25-75%) using a spirometer and quality of life using European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 version 3.0 were objectively evaluated.

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients were previously diagnosed with a hematological malignancy and determined to be a candidate for allogeneic-HSCT who were orientated from Bone Marrow Transplantation Unit for rehabilitation program. Healthy individuals were recruited from staff in the university and their healthy relatives.

You may qualify if:

• being aged between 18 and 65 years, being a candidate for either allogeneic or autologous HSCT before the start of conditioning regimen who were orientated from Bone Marrow Transplantation Unit,
• having a diagnosis with a hematologic malignancy,
• being clinically stabile,
• being functionally mobile
• receiving optimal standard medical therapy including antibiotics, supplements and other drugs.

You may not qualify if:

• having cooperation problems, having orthopedic or neurological disease with a potential to limit daily walking,
• having comorbidities such as chronic obstructive pulmonary disease, cardiac diseases, acute infections and/or active hemorrhage (with hemoglobin values ≤8 g/L and platelet count ≤10.000 mm3)
• being eager to participate to the study
• being aged between 18 and 65 years,
• having any diagnosis of chronic diseases
• being current smokers
• being ex-smokers (≥10 pack\*years)

Sponsors & Collaborators

• Gazi University: lead

Related Publications (10)

• Copelan EA. Hematopoietic stem-cell transplantation. N Engl J Med. 2006 Apr 27;354(17):1813-26. doi: 10.1056/NEJMra052638. No abstract available.

  PMID: 16641398 RESULT

• Paudel N, Schulze D, Gentzler RD, Evens AM, Helenowski I, Dillehay G, Frankfurt O, Mehta J, Donnelly ED, Gordon LI, Winter JN, Mittal BB. Patterns of Failure and Survival Outcomes after Total Lymphoid Irradiation and High-Dose Chemotherapy with Autologous Stem Cell Transplantation for Relapsed or Refractory Classical Hodgkin Lymphoma. Int J Radiat Oncol Biol Phys. 2019 Jun 1;104(2):436-446. doi: 10.1016/j.ijrobp.2019.02.007. Epub 2019 Feb 11.

  PMID: 30763660 RESULT

• Mohammed J, Smith SR, Burns L, Basak G, Aljurf M, Savani BN, Schoemans H, Peric Z, Chaudhri NA, Chigbo N, Alfred A, Bakhsh H, Salooja N, Chris Chim A, Hashmi SK. Role of Physical Therapy before and after Hematopoietic Stem Cell Transplantation: White Paper Report. Biol Blood Marrow Transplant. 2019 Jun;25(6):e191-e198. doi: 10.1016/j.bbmt.2019.01.018. Epub 2019 Jan 15.

  PMID: 30658224 RESULT

• Wingard JR, Majhail NS, Brazauskas R, Wang Z, Sobocinski KA, Jacobsohn D, Sorror ML, Horowitz MM, Bolwell B, Rizzo JD, Socie G. Long-term survival and late deaths after allogeneic hematopoietic cell transplantation. J Clin Oncol. 2011 Jun 1;29(16):2230-9. doi: 10.1200/JCO.2010.33.7212. Epub 2011 Apr 4.

  PMID: 21464398 RESULT

• Majhail NS, Rizzo JD, Lee SJ, Aljurf M, Atsuta Y, Bonfim C, Burns LJ, Chaudhri N, Davies S, Okamoto S, Seber A, Socie G, Szer J, Van Lint MT, Wingard JR, Tichelli A; Center for International Blood and Marrow Transplant Research (CIBMTR); American Society for Blood and Marrow Transplantation (ASBMT); European Group for Blood and Marrow Transplantation (EBMT); Asia-Pacific Blood and Marrow Transplantation Group (APBMT); Bone Marrow Transplantation Society of Australia and New Zeland (BMTSANZ); East Mediterrnean Blood and Marrow Transplantation Group (EMBMT); Sociedale Brasileira de Transplante de Medula Ossea (SBTMO). [Recommended screening and preventive practices for long-term survivors after hematopoietic cell transplantation]. Rinsho Ketsueki. 2014 Jun;55(6):607-32. Japanese.

  PMID: 24975331 RESULT

• Vermaete N, Wolter P, Verhoef G, Gosselink R. Physical activity and physical fitness in lymphoma patients before, during, and after chemotherapy: a prospective longitudinal study. Ann Hematol. 2014 Mar;93(3):411-24. doi: 10.1007/s00277-013-1881-3. Epub 2013 Aug 21.

  PMID: 23963412 RESULT

• Hung YC, Bauer J, Horsley P, Waterhouse M, Bashford J, Isenring E. Changes in nutritional status, body composition, quality of life, and physical activity levels of cancer patients undergoing autologous peripheral blood stem cell transplantation. Support Care Cancer. 2013 Jun;21(6):1579-86. doi: 10.1007/s00520-012-1698-y. Epub 2013 Jan 10.

  PMID: 23306934 RESULT

• White AC, Terrin N, Miller KB, Ryan HF. Impaired respiratory and skeletal muscle strength in patients prior to hematopoietic stem-cell transplantation. Chest. 2005 Jul;128(1):145-52. doi: 10.1378/chest.128.1.145.

  PMID: 16002928 RESULT

• Morishita S, Kaida K, Yamauchi S, Wakasugi T, Ikegame K, Ogawa H, Domen K. Relationship of physical activity with physical function and health-related quality of life in patients having undergone allogeneic haematopoietic stem-cell transplantation. Eur J Cancer Care (Engl). 2017 Jul;26(4). doi: 10.1111/ecc.12669. Epub 2017 Feb 21.

  PMID: 28220548 RESULT

• Morishita S, Kaida K, Tanaka T, Itani Y, Ikegame K, Okada M, Ishii S, Kodama N, Ogawa H, Domen K. Prevalence of sarcopenia and relevance of body composition, physiological function, fatigue, and health-related quality of life in patients before allogeneic hematopoietic stem cell transplantation. Support Care Cancer. 2012 Dec;20(12):3161-8. doi: 10.1007/s00520-012-1460-5. Epub 2012 Apr 12.

  PMID: 22526152 RESULT

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Gülşah Barğı, PhD

  Gazi University

  STUDY CHAIR

• Meral Boşnak Güçlü, PhD

  Gazi University

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: April 11, 2019
• First Posted: April 16, 2019
• Study Start: January 1, 2012
• Primary Completion: November 1, 2014
• Study Completion: December 1, 2014
• Last Updated: October 22, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share