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OpenTrials
Completed

NCT Number: NCT03103308

Hematopoetic Stem Cell Transplant and Physical Function

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.

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Key information

Conditions

Cancer Behavior Motor Activity Neoplasms Walking

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sylvester Comprehensive Cancer Center

Miami, Florida, 33136, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Walk Training and Transplant

Other

Subjects will receive free activity monitors and have three training sessions per week for the duration of their bone marrow transplant treatment

Activity Monitoring and Transplant

Other

Subjects will receive free activity monitors for the duration of their bone marrow transplant treatment

Primary outcomes

  1. The Physical Performance Test Battery

    Time frame: 10 minutes

    Physical Function

Secondary outcomes

  1. Functional Assessment of Cancer Therapy: Bone Marrow Transplant Questionaire Related Quality of Life

    Time frame: 20 minutes

    Health-related quality of Life

  2. Patient Reported Outcome Measurement Information System

    Time frame: 20 minutes

    Health Related Quality of Life

Sponsors and collaborators

Lead sponsor

University of Miami

Other

Registry information

Official study title

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

Acronym: HSCT

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Apr 6, 2017
Registry last updated
Apr 6, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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