Hematopoetic Stem Cell Transplant and Physical Function
HSCT
Effects of a Multidirectional Walking Program on Physical Function and Quality of Life in Hematopoetic Stem Cell Transplant Patients
1 other identifier
interventional
25
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable cancer
Started May 2017
Shorter than P25 for not_applicable cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 17, 2017
CompletedFirst Posted
Study publicly available on registry
April 6, 2017
CompletedStudy Start
First participant enrolled
May 16, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 15, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2018
CompletedApril 6, 2018
April 1, 2018
10 months
March 17, 2017
April 5, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The Physical Performance Test Battery
Physical Function
10 minutes
Secondary Outcomes (2)
Functional Assessment of Cancer Therapy: Bone Marrow Transplant Questionaire Related Quality of Life
20 minutes
Patient Reported Outcome Measurement Information System
20 minutes
Study Arms (2)
Walk training and transplant
EXPERIMENTALMultidirectional walk training with activity monitoring after bone marrow transplant
Activity Monitoring and transplant
EXPERIMENTALActivity monitoring alone after bone marrow transplant.
Interventions
Subjects will receive free activity monitors and have three training sessions per week for the duration of their bone marrow transplant treatment
Subjects will receive free activity monitors for the duration of their bone marrow transplant treatment
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Sylvester Comprehensive Cancer Center
Miami, Florida, 33136, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
March 17, 2017
First Posted
April 6, 2017
Study Start
May 16, 2017
Primary Completion
March 15, 2018
Study Completion
April 1, 2018
Last Updated
April 6, 2018
Record last verified: 2018-04