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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03103308
Other study ID # 20160711
Secondary ID
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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