Hematopoetic Stem Cell Transplant and Physical Function (HSCT)

April 5, 2018 updated by: Joseph Signorile, University of Miami

Effects of a Multidirectional Walking Program on Physical Function and Quality of Life in Hematopoetic Stem Cell Transplant Patients

This study will determine if a structured walking intervention will help maintain or improve physical activity levels, physical function and quality of life in hematopoietic stem cell transplant patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The researchers will quantify the decline in physical function of HSCT patients using valid and reliable tests aimed to mimic activities of daily living, quantify cardiovascular health, and quantify muscle power declines. Also, patients will undergo a walking program during their hospitalization, which is designed to increase physical activity levels and maintain and improve physical function and quality of life. Additionally, using valid and reliable questionnaires, the researchers will gauge perception of exercise, quantify current exercise levels, determine preference of exercise programs and counseling, and measure differences in quality of life before and after HSCT treatment.

Study Type

Interventional

Enrollment (Actual)

25

Phase

  • Not Applicable

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

  • United States
    • Florida
      • Miami, Florida, United States, 33136
        • Sylvester Comprehensive Cancer Center

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

40 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Be between 40 and 80 years of age
  • Willing and able to provide written informed consent in English
  • Ability to comprehend the purpose of the study
  • Be scheduled to receive an autologous or allogeneic hematopoietic stem cell transplant at Sylvester Comprehensive Cancer Center
  • Have an expected hospital stay of at least 2 weeks
  • Not currently be participating in an exercise training program

Exclusion Criteria:

  • Dementia, altered mental status, or psychiatric condition
  • Received erythropoiesis-stimulating proteins within 4 weeks prior to enrollment
  • Comorbid conditions that would contraindicate exercise testing
  • Undergoing concurrent non-transplant-related chemotherapy or radiation

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

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Walk training and transplant
Multidirectional walk training with activity monitoring after bone marrow transplant
Other: Walk Training and Transplant
Subjects will receive free activity monitors and have three training sessions per week for the duration of their bone marrow transplant treatment
Experimental: Activity Monitoring and transplant
Activity monitoring alone after bone marrow transplant.
Other: Activity Monitoring and Transplant
Subjects will receive free activity monitors for the duration of their bone marrow transplant treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Physical Performance Test Battery
Time Frame: 10 minutes
Physical Function
10 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Functional Assessment of Cancer Therapy: Bone Marrow Transplant Questionaire Related Quality of Life
Time Frame: 20 minutes
Health-related quality of Life
20 minutes
Patient Reported Outcome Measurement Information System
Time Frame: 20 minutes
Health Related Quality of Life
20 minutes

Collaborators and Investigators

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

Sponsor

University of Miami

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)

May 16, 2017

Primary Completion (Actual)

March 15, 2018

Study Completion (Actual)

April 1, 2018

Study Registration Dates

First Submitted

March 17, 2017

First Submitted That Met QC Criteria

March 31, 2017

First Posted (Actual)

April 6, 2017

Study Record Updates

Last Update Posted (Actual)

April 6, 2018

Last Update Submitted That Met QC Criteria

April 5, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 20160711

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.

Clinical Trials on Cancer

Clinical Trials on Walk Training and Transplant

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Indonesia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe