Physical Impairments in Allogeneic-HSCT

April 11, 2019 updated by: Meral Boşnak Güçlü, Gazi University

Physiological Responses to Maximal Exercise Capacity and Muscle Strength in Survived Hematopoietic Stem Cell Transplantation Recipients

Pulmonary functions, exercise capacity and muscle strength deteriorate in survived hematopoietic stem cell transplantation (HSCT) recipients due to toxic effects of chemotherapy, radiotherapy, conditioning regimens and/or corticosteroid use before HSCT, prolonged stay of recipients in rooms with laminar airflow and strict infection control rules during process of HSCT. There are also limited numbers of studies demonstrated pulmonary function abnormalities, decreased maximal exercise capacity, respiratory and peripheral muscle weakness in recipients. Current study was planned since no study compared pulmonary functions, maximal exercise capacity, respiratory and peripheral muscle strength between recipients and healthy individuals in the literature.

Study Overview

Status

Completed

Conditions

Detailed Description

Treatments of hematologic malignancies consist of chemotherapy, radiotherapy, surgery, medical treatment, supportive care and/or hematopoietic stem cell transplantation (HSCT) which is resulted in early or late adverse effects on body systems, tissues and organs. Physical deconditioning is also observed in patients with hematologic malignancies because of reasons such as neurotoxic and pulmonary toxic effects of long term these anticancer treatments, immobilization, recommendation of resting and avoiding intense exercise, nutrition problems, severe anemia and thrombocytopenia etc. For these reasons, normal physical activities may not be kept on by patients which induces decreased physical performance.

The HSCT provides longer survival with standard treatments for patients with hematological malignancies while it increases risk of HSCT-related toxicity, complications and even mortality. Infectious and non-infectious pulmonary complications occur in about 60% of HSCT recipients and intensive-care unit support is also required in one-third of recipients for these reasons. Restrictive lung disease prior to allogeneic HSCT is related to early respiratory failure, non-relapse mortality and respiratory muscle weakness in post transplantation period. Therefore pulmonary restriction is considered as a risk factor for complications or failure of HSCT. Moreover it is known that carbon monoxide diffusing capacity of lungs which is the most common abnormality seen in pulmonary function test, respiratory muscle strength and functional exercise capacity are reduced in the majority of patients before HSCT. In addition to muscle weakness and decreased exercise capacity at prior to HSCT, patients experience more reduction in both inspiratory and expiratory muscles and exercise capacity after HSCT. Unfortunately, exercise capacity and peripheral muscle strength are decreased in HSCT recipients in spite of doing regular and planned exercise during acute process of HSCT. The average reduction in functional exercise capacity of recipients is 48 m. As shown in the literature, limited number of study has used evaluation of maximal exercise capacity with Modified-Incremental Shuttle Walk Test (ISWT) in HSCT patients and recipients. On the other hand, it has been reported that ISWT is a reliable test and has no adverse event or side effects for HSCT recipients in these studies, as well. Despite the fact that there is no negative feedback related to using of this test in recipients, no study comprehensively demonstrated influence of HSCT on maximal exercise capacity.

Impairments in pulmonary functions, respiratory muscle strength and maximal exercise capacity have been demonstrated in limited number of studies. Moreover, there is no study compared pulmonary functions, respiratory muscle strength and maximal exercise capacity between HSCT recipients and healthy individuals. Therefore investigators aimed to compare aforementioned outcomes between recipients and healthy individuals.

Study Type

Observational

Enrollment (Actual)

122

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Ankara, Turkey, 06010
        • Gazi University Faculty of Health Science Department of PhysioTherapy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

66 recipients underwent allogeneic HSCT who were at minimum 100 days status post-transplantation compared with 50 healthy individuals.

All recipients transplanted at the Bone Marrow Transplantation Unit of University Faculty of Medicine. All measurements were done by a physiotherapist at Cardiopulmonary Unit of University Faculty of Health Science Department of Physiotherapy and Rehabilitation. Demographic and clinical characteristics of all participants were recorded. 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.

Description

Inclusion Criteria for recipients:

  • between ages of 18 and 70
  • under standard medical treatment
  • underwent allogeneic HSCT who were at minimum 100 days status post-transplantation

Exclusion Criteria for recipients:

  • having cognitive disorder, orthopedic or neurological disease with a potential to affect assessment of maximal exercise capacity,
  • having comorbidities such as asthma, chronic obstructive pulmonary disease (COPD), acute respiratory or other infections,
  • having problems like visual and mucositis which may prevent measurements,
  • acute hemorrhage anywhere in the body,
  • hemoglobin value less than 8 g/L and platelet count less than 10.000 mm3

Inclusion Criteria for healthy individuals:

  • being individuals without known and diagnosed any chronic diseases
  • not actively smoking
  • their cigarette exposure is not greater than 5 pack*year.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Group 1: HSCT recipients
Pulmonary functions [spirometry], maximal exercise capacity [Modified-Incremental Shuttle Walk Test (ISWT)], inspiratory and expiratory muscle strength (MIP and MEP, respectively) [mouth pressure device] and peripheral muscle strength [hand-held dynamometer] were evaluated in allogeneic HSCT recipients (n=66).Vital signs, dyspnea and fatigue perception [Modified Borg Scale] were recorded as pre-post measurements of Modified-ISWT.
Group 2: healthy individuals
Healthy individuals (n=50) were selected from individuals without known and diagnosed any chronic diseases. Similar measurements were applicated in healthy individuals.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Modified-Incremental Shuttle Walk Test (ISWT)
Time Frame: 15-20 minutes
This test was used to evaluate maximal exercise capacity
15-20 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
pulmonary function test
Time Frame: 5 minutes
This test was evaluated using a spirometry
5 minutes
inspiratory and expiratory muscle strength (MIP, MEP)
Time Frame: 5-10 minutes
Respiratory muscle strength was evaluated with a mouth pressure device
5-10 minutes
Quadriceps femoris muscle strength
Time Frame: 5 minutes
Peripheral muscle strength was evaluated with a hand-held dynamometer
5 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gazi University

Investigators

  • Study Chair: Gülşah Barğı, PhD, Gazi University
  • Study Director: Meral Boşnak Güçlü, PhD, Gazi University
  • Principal Investigator: Gülsan Türköz Sucak, Bahçeşehir University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2012

Primary Completion (Actual)

November 1, 2014

Study Completion (Actual)

December 1, 2017

Study Registration Dates

First Submitted

February 22, 2018

First Submitted That Met QC Criteria

February 22, 2018

First Posted (Actual)

February 28, 2018

Study Record Updates

Last Update Posted (Actual)

April 16, 2019

Last Update Submitted That Met QC Criteria

April 11, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • GaziUniversity6

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

There is not a plan to make individual participant data but when the statistical analyses of all data are made, all results will be shared.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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