Hematopoetic Stem Cell Transplant and Physical Function

Not Applicable

Completed

• Conditions: Walking; Cancer
• Interventions: Other: Activity Monitoring and Transplant; Other: Walk Training and Transplant

• Registration Number: NCT03103308
• Lead Sponsor: University of Miami

Brief Summary

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.

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2017-03-17
• Study First Submitted QC: 2017-03-31
• Study First Posted: 2017-04-06
• Study Start: 2017-05-16
• Primary Completion: 2018-03-15
• Status Verified: 2018-04
• Study Completion: 2018-04-01
• Last Update Submitted: 2018-04-05
• Last Update Posted: 2018-04-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Activity Monitoring and transplant	Activity Monitoring and Transplant	Activity monitoring alone after bone marrow transplant.
Walk training and transplant	Walk Training and Transplant	Multidirectional walk training with activity monitoring after bone marrow transplant

Primary Outcome Measures

Name	Time	Method
The Physical Performance Test Battery	10 minutes	Physical Function

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Sylvester Comprehensive Cancer Center; 🇺🇸 Miami, Florida, United States