CancerHSCTNCT03103308
Hematopoetic Stem Cell Transplant and Physical Function
A study testing Walk Training and Transplant and Activity Monitoring and Transplant in people with Cancer and Walking, run by University of Miami at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- What is being tested?
- Walk Training and Transplant and Activity Monitoring and Transplant
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 16 May 2017to 1 Apr 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Sylvester Comprehensive Cancer Center
Miami, Florida, 33136
About this study
Official title: Effects of a Multidirectional Walking Program on Physical Function and Quality of Life in Hematopoetic Stem Cell Transplant Patients
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.
Read the 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.
- Being tested
- Walk Training and Transplant, Activity Monitoring and Transplant
- Keywords
- Cancer, Exercise, Physical Function
- Medical subject headings
- Neoplasms, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Walk Training and TransplantOther
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 TransplantOther
Subjects will receive free activity monitors for the duration of their bone marrow transplant treatment
| Study group | Role | What they receive |
|---|---|---|
| Walk training and transplant | Experimental | Multidirectional walk training with activity monitoring after bone marrow transplant Receives: Other: Walk Training and Transplant |
| Activity Monitoring and transplant | Experimental | Activity monitoring alone after bone marrow transplant. Receives: Other: Activity Monitoring and Transplant |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Physical Performance Test Battery
Physical Function
Measured: 10 minutes
Secondary outcomes (2)
Functional Assessment of Cancer Therapy: Bone Marrow Transplant Questionaire Related Quality of Life
Health-related quality of Life
Measured: 20 minutes
Patient Reported Outcome Measurement Information System
Health Related Quality of Life
Measured: 20 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2017
- Study start16 May 2017
- Primary completion15 Mar 2018
- Study completion1 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joseph Signorile, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03103308
- Sponsor's protocol ID
- 20160711
- Acronym
- HSCT
- Status last verified
- Apr 2018
- First submitted
- 17 Mar 2017
- Last updated
- 6 Apr 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Multidirectional Walking Program on Physical Function and Quality of Life in Hematopoetic Stem Cell Transplant Patients
- ClinicalTrials.gov ID
- NCT03103308
- Acronym / sponsor ID
- HSCT / 20160711
- Keywords
- Cancer, Exercise, Physical Function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Study start
- 16 May 2017 (actual)
- Primary completion
- 15 Mar 2018 (actual)
- Study completion
- 1 Apr 2018 (actual)
- First posted
- 6 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Walk training and transplant | Experimental | Other: Walk Training and TransplantMultidirectional walk training with activity monitoring after bone marrow transplant |
| Activity Monitoring and transplant | Experimental | Other: Activity Monitoring and TransplantActivity monitoring alone after bone marrow transplant. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Walk Training and TransplantSubjects will receive free activity monitors and have three training sessions per week for the duration of their bone marrow transplant treatment | Other | Walk training and transplant |
| Activity Monitoring and TransplantSubjects will receive free activity monitors for the duration of their bone marrow transplant treatment | Other | Activity Monitoring and transplant |
Primary outcome
The Physical Performance Test Battery
Time frame: 10 minutes
Physical Function
2 secondary outcomes
Functional Assessment of Cancer Therapy: Bone Marrow Transplant Questionaire Related Quality of Life
Time frame: 20 minutes
Patient Reported Outcome Measurement Information System
Time frame: 20 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Walk Training and Transplant and Activity Monitoring and Transplant in people with Cancer and Walking, run by University of Miami at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Physical Performance Test Battery (time frame: 10 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2018.