Hematopoetic Stem Cell Transplant and Physical Function

Cancer Clinical Trial

— HSCT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03103308
• Other study ID #: 20160711
• Status: Completed
• Phase: N/A
• First received: March 17, 2017
• Last updated: April 5, 2018
• Start date: May 16, 2017
• Est. completion date: April 1, 2018

Study information

• Verified date: April 2018
• Source: University of Miami
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: April 1, 2018
• Est. primary completion date: March 15, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Cancer
• Walking

Intervention

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
• Activity Monitoring and Transplant
Subjects will receive free activity monitors for the duration of their bone marrow transplant treatment

Locations

Country	Name	City	State
United States	Sylvester Comprehensive Cancer Center	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Miami

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Physical Performance Test Battery	Physical Function	10 minutes
Secondary	Functional Assessment of Cancer Therapy: Bone Marrow Transplant Questionaire Related Quality of Life	Health-related quality of Life	20 minutes
Secondary	Patient Reported Outcome Measurement Information System	Health Related Quality of Life	20 minutes