Physical Inactivity in Candidates of HSCT

October 20, 2020 updated by: Meral Boşnak Güçlü, Gazi University

Physical Activity Level, Pulmonary Functions and Quality of Life in Candidates of Hematopoietic Stem Cell Transplantation and Healthy Individuals: a Cross-sectional Study

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.

Study Overview

Status

Completed

Conditions

Detailed Description

In recent years, hematopoietic stem cell transplantation (HSCT) has been largely used to cure not only many hematologic malignancies but also autoimmune diseases and even genetic diseases. Advances in the HSCT and other cancer treatment approaches including supportive care practices provide patients better survival time nowadays. However, as life expectancy for recipients is increasing up to 85% for being alive 10 years after HSCT, post-HSCT complications are concurrently increasing. After HSCT, recipients may suffer from many infectious complications, cytopenia, immunosuppression, graft versus host disease, a lot of organ involvements and even secondary malignancies. In addition, they are also exposed to immobility condition, physical inactivity, depressive symptoms, psychosocial distress, fatigue, and complications of musculoskeletal, respiratory and cardiovascular systems rely on mostly treatments and treatment related with complications all of which have a negative impact on the survival, physical functions and quality of life of recipients. Hence, the guidelines recommend to all recipients both routine evaluations of clinical and cardiovascular risk factors, and also complying with healthy life style including doing regular physical activity and exercises.

On the other hand, chemotherapy, radiation therapy and further conditioning regimens are required to exterminate the abnormally proliferating cancer cells in patients with hematologic malignancies before HSCT, which also leads to pre-HSCT complications. These complications are observed as physical inactivity, abnormal pulmonary functions, muscle weakness, decreased exercise capacity, evident fatigue, psychological mood disorders and poorer quality of life in these patients until HSCT. Should immobility and physical inactivity extend, the patients may need to respiratory support including oxygen supply, noninvasive or invasive mechanic ventilation. As previously shown, these impairments especially physical inactivity have even existed in patients with hematologic malignancies at the period of pre-diagnosis and early diagnosis. While 33.8% of patients (n=438) could achieve the daily/weekly exercise criteria of guidelines during the time of pre-diagnosis, only 6.5% of patients could perform physical activity during anticancer treatments. In that study, physical activity level was evaluated using a questionnaire, and the patients meeting public health exercise guidelines have reported higher quality of life level. According to results of another study with higher sample size (n=3060), 1392 (46%) of patients are physically active based on their responses to questions at the pre-diagnosis period. However, the most striking result to emerge from the data in 2018 is that these active patients have considerably higher survival rates rather than insufficiently active patients. As demonstrated in 2014 (n=29), 61% of patients with early diagnosis meet the physical activity guidelines, and patients walk about 6.149 steps/d before the start of chemotherapy which was evaluated via a tri-axial accelerometer. As known, although patients have survived after HSCT, these problems have not meliorated in survivors over a long time after HSCT. Therefore, guidelines recommend that the patients should be oriented for rehabilitation in order to maximize muscle strength, functional mobility and quality of life of patients before the patients are subject to the process of HSCT.

Evaluation and counseling of physical activity have become one of the most challenging topics recently; however, there is confusion in the meaning and usage of this term. Original definition of physical activity is "Physical activity is defined as any bodily movement produced by skeletal muscles that results in energy expenditure. Physical activity in daily life can be categorized into occupational, sports, conditioning, household, or other activities. Exercise is a subset of physical activity that is planned, structured, and repetitive and has as a final or an intermediate objective the improvement or maintenance of physical fitness.". In the literature, researchers have mostly tend to only one aspect of physical activity measurement in candidates of HSCT which is either steps count or estimation of physical activity intensity as regard to metabolic equivalent of daily task (MET). In fact, reason of this situation was that less objective tools such as questionnaire, questions, and pedometers were used to evaluate physical activity level in candidates. There is just a few studies used an objective device like triaxial accelerometer in the literature.

Physical inactivity as a cardiovascular risk factor is related with higher risks of cardiovascular diseases and complications after HSCT. Therefore, it is important to assess detailed physical activity along with its all aspects including energy expenditure, number of steps, activity types and durations in candidates of HSCT. However, impairments in energy expenditure, physical activity duration, metabolic equivalents of daily task (METs) and lying down duration are still unknown in candidates versus healthy individuals who are age and gender matched counterparts of candidates. Hence, it was aimed to compare physical activity parameters, pulmonary functions and quality of life scores of candidates with healthy individuals in the current study.

Study Type

Observational

Enrollment (Actual)

94

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 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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.

Description

Inclusion Criteria for the candidates:

  • 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.

Exclusion Criteria for the candidates:

  • 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)

Inclusion Criteria for the healthy individuals:

  • being eager to participate to the study
  • being aged between 18 and 65 years,

Exclusion Criteria for the healthy individuals:

  • having any diagnosis of chronic diseases
  • being current smokers
  • being ex-smokers (≥10 pack*years)

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

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Physical activity measurement
Time Frame: during a total of 48 hours
Physical activity levels of all participants were assessed with a metabolic holter device.
during a total of 48 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of dynamic lung volumes
Time Frame: 5 minutes
To assess dynamic lung volumes involving forced vital capacity (FVC), forced expiratory volume in one second (FEV1), forced expiratory volume in one second/forced vital capacity (FEV1/FVC), peak expiratory flow (PEF) and forced expiratory flow at 25%-75% (FEF25-75%), a spirometer was used. Guidelines were taken reference for this measurement. These values were recorded as percentages of predicted values.
5 minutes
General quality of life assesment: European Organization for Research and Treatment of Cancer QOL Questionnaire (EORTCQOL)
Time Frame: 2 minutes
European Organization for Research and Treatment of Cancer QOL Questionnaire C30 version3.0 was used to evaluate quality of life impairment. This is a self-administered questionnaire which consists of five functional subscales along with a social functioning subscale, three symptom subscales with also a fatigue subscale, a global health status subscale, and several single items. All item scores are converted to values from 0 to 100. Higher values show higher health levels in functional and social functioning subscales, a higher quality of life level in global health status subscale, and increased presence of symptoms in both symptom and fatigue subscales.
2 minutes

Collaborators and Investigators

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

Sponsor

Gazi 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)

January 1, 2012

Primary Completion (Actual)

November 1, 2014

Study Completion (Actual)

December 1, 2014

Study Registration Dates

First Submitted

April 11, 2019

First Submitted That Met QC Criteria

April 12, 2019

First Posted (Actual)

April 16, 2019

Study Record Updates

Last Update Posted (Actual)

October 22, 2020

Last Update Submitted That Met QC Criteria

October 20, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • GaziUniversity18

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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