Physical Functions in Allogeneic-HSCT Candidates

NCT03915249 | Completed

• 1 other identifier: GaziUniversity17
• Study Type: observational
• Target: 49
• Locations: 0 countries
• Sites: N/A

Brief Summary

Physical inactivity and impairments in physical functions have been observed in patients due to hematological malignancy itself and treatments of chemotherapy, radiotherapy, corticosteroids. However, no study investigated relationship of physical activity with pulmonary and physical functions in allogeneic hematopoietic stem cell transplantation (HSCT) candidates. Therefore, investigation of the relationship among outcomes in allogeneic HSCT candidates was aimed.

Conditions

Stem Cell Transplantation

Keywords

Energy metabolism; Exercise test; Leisure activities; Hematopoietic stem cell transplantation; Muscle strength; Respiratory function test; Exercise

Outcome Measures

Primary Outcomes (1)

• Physical activity measurement

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

  during a total of 48 hours

Secondary Outcomes (4)

• Pulmonary function assessment

  5 minutes

• inspiratory and expiratory muscle strength (MIP, MEP)

  5-10 minutes

• Quadriceps femoris muscle strength

  5 minutes

• Six-minute walk test

  10 minutes

Study Arms (1)

Allogeneic-HSCT candidates

Physical activity, pulmonary functions (FEV1, FVC, FEV1/FVC, FEF25-75%, PEF), exercise capacity, respiratory (maximal inspiratory and expiratory pressures (MIP, MEP)) and peripheral muscle strength were evaluated in allogeneic-HSCT candidates.

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• 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.Study was planned as retrospective, cross sectional and approved by the local Ethics Committee. Informed consent was obtained from all individual participants included in the study.

You may qualify if:

• being 18-65 years of age,
• having a diagnosis with hematologic malignancy
• being clinically stabile,
• being an allogeneic-HSCT candidate
• 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 prevent assessment of exercise capacity,
• having comorbidities such as chronic obstructive pulmonary disease, cardiac diseases,
• acute infections and/or hemorrhage.

Sponsors & Collaborators

• Gazi University: lead

Related Publications (7)

• Bergenthal N, Will A, Streckmann F, Wolkewitz KD, Monsef I, Engert A, Elter T, Skoetz N. Aerobic physical exercise for adult patients with haematological malignancies. Cochrane Database Syst Rev. 2014 Nov 11;(11):CD009075. doi: 10.1002/14651858.CD009075.pub2.

  PMID: 25386666 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

• Gillis TA, Donovan ES. Rehabilitation following bone marrow transplantation. Cancer. 2001 Aug 15;92(4 Suppl):998-1007. doi: 10.1002/1097-0142(20010815)92:4+3.0.co;2-k.

  PMID: 11519026 RESULT

• Steinberg A, Asher A, Bailey C, Fu JB. The role of physical rehabilitation in stem cell transplantation patients. Support Care Cancer. 2015 Aug;23(8):2447-60. doi: 10.1007/s00520-015-2744-3. Epub 2015 May 14.

  PMID: 25971213 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, Ikegame K, Yoshihara S, Taniguchi K, Okada M, Kodama N, Ogawa H, Domen K. Impaired physiological function and health-related QOL in patients before hematopoietic stem-cell transplantation. Support Care Cancer. 2012 Apr;20(4):821-9. doi: 10.1007/s00520-011-1156-2. Epub 2011 Apr 9.

  PMID: 21479522 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

• Gülsan Türköz Sucak, PhD.

  Medikalpark hastanesi

  PRINCIPAL INVESTIGATOR

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, 2017
• Primary Completion: December 1, 2018
• Study Completion: February 1, 2019
• Last Updated: April 19, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share