Allogeneic HCT SurvivorsNCT03609203
Improving Self-Efficacy, Resolving Inflammaging Allo HSCT Survivors in Personal Training
An observational study of Allogeneic HCT Survivors, run by Masonic Cancer Center, University of Minnesota at 1 site in United States.
Trial summary
This protocol is a pilot study of a personalized and supervised 10-week strength training program to improve self-efficacy and resolve biomarkers of inflammaging in a cohort of allogeneic hematopoietic transplant (HCT) long-term survivors versus healthy controls. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Allogeneic HCT Survivors
- What is being tested?
- 10 Weeks of Strength Trailing and Group Nutrition Discussion: week 1, week 5 and week 10
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Sep 2018to 31 Mar 2021
- Phase
- Observational
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: A maximum of four pairs of patient/workout partners (8 subjects) should be actively participating in the 10-week group intervention on study at a time. Participants may sign consent at anytime but then begin group participation when spots become available.
Who may be able to join
- HCT recipients
- Age ≥ 18 years
- Greater than 6 months after completing systemic multiagent chemotherapy (greater than 12 months for HCT participants) at the time of enrollment. Maintenance chemotherapy is allowed
- In remission from cancer Off immunosuppression, or on a stable immunosuppression regimen with prednisone doses ≤ 20 mg daily, with no changes planned to the immunosuppression regimen during the study period
- Karnofsky performance status ≥ 50% (Appendix III)
- Platelet count ≥ 50,000 without transfusions
Show all 19Show fewer
- Absolute neutrophil count ≥ 1
- Willing to complete weekly strength training sessions for 10 consecutive weeks and complete all pre- and post-testing (self-efficacy survey and research blood draw)
- Currently reside within the Minneapolis-St. Paul metro area
- Has an adult (age ≥ 18) friend or relative who is willing to serve as an exercise partner and healthy control for the study
- If known diabetic: Stable doses of medications to treat diabetes within 4 weeks prior to enrollment
- Willing and able to sign voluntary written consent
- Healthy Controls
- Age ≥ 18 years
- Karnofsky performance status ≥ 50%
- Willing to complete weekly strength training sessions for 10 consecutive weeks and complete all pre- and post-testing (self-efficacy survey and research blood draw)
- Currently reside within the Minneapolis-St. Paul metro area
- If known diabetic: Stable doses of medications to treat diabetes within 4 weeks prior to enrollment
- Willing and able to sign voluntary written consent
Who cannot join
- Presence of an external central venous catheter (Hickman, PICC, etc); Port-a-cath devices that are completely internal are allowed
- Use of ≥ 20+ mg prednisone daily
- Current or planned use of investigational drugs during the study period
- Myocardial infarction or stroke within 6 months
- Heart failure graded Class IV on New York Heart Association (NYHA) scale (https://manual.jointcommission.org/releases/TJC2018A/DataElem0439.html)
- Any medical condition that the consenting medical provider deems would make the participant unsafe to perform a 10-week strength training program
- Are currently pregnant
Trial locations and contacts
1 site in 1 country.
United States1 site
Masonic Cancer Center, University of Minnesota
Minneapolis, Minnesota, 55455
About this study
Official title: Improving Self-Efficacy and Resolving Inflammaging in Allogeneic Hematopoietic Cell Transplant Survivors Through Personalized Strength Programming: A Pilot Study
This protocol is a pilot study of a personalized and supervised 10-week strength training program to improve self-efficacy and resolve biomarkers of inflammaging in a cohort of allogeneic hematopoietic transplant (HCT) long-term survivors versus healthy controls.
- Conditions
- Allogeneic HCT Survivors
- Being tested
- 10 Weeks of Strength Trailing, Group Nutrition Discussion: week 1, week 5 and week 10
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
10 Weeks of Strength TrailingOther
Week 1 (pre training session): self efficacy survey; 5-point frailty assessment*; diet survey; metabolic assessment; Functional status and body composition; blood and stool sample
Week 5: self efficacy survey; Functional status and body composition
Week 10: self efficacy survey; 5-point frailty assessment*; diet survey; metabolic assessment; Functional status and body composition; blood and stool samples
Group Nutrition Discussion: week 1, week 5 and week 10Other
Week 1 (pre training session): self efficacy survey; 5-point frailty assessment*; diet survey; metabolic assessment; Functional status and body composition; blood and stool sample
Week 5: self efficacy survey; Functional status and body composition
Week 10: self efficacy survey; 5-point frailty assessment*; diet survey; metabolic assessment; Functional status and body composition; blood and stool samples
| Study group | Role | What they receive |
|---|---|---|
| Patients | Not described Receives: Other: 10 Weeks of Strength Trailing; Other: Group Nutrition Discussion: week 1, week 5 and week 10 | |
| Controls | Not described Receives: Other: 10 Weeks of Strength Trailing; Other: Group Nutrition Discussion: week 1, week 5 and week 10 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-reported outcomes of self-efficacy
To quantify the changes in self-reported outcomes of self-efficacy after ten weeks of strength training in patients compared to controls.
Measured: Week 10
Secondary outcomes (1)
Biomarkers of inflammaging in the blood
To evaluate changes in biomarkers of inflammaging in the blood of HCT recipients before and after the intervention compared to controls.
Measured: Week 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2018
- Study start10 Sep 2018
- Primary completion31 Mar 2021
- Study completion31 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Allogeneic HCT SurvivorsStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Masonic Cancer Center, University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shernan G Holtan, MD, Principal investigator, Division of Hematology, Oncology and Transplantation, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03609203
- Sponsor's protocol ID
- 2018NTLS073
- Other IDs
- MT2018-09R
- Status last verified
- Mar 2022
- First submitted
- 24 Jul 2018
- Last updated
- 4 Apr 2022
- 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 4 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Self-Efficacy and Resolving Inflammaging in Allogeneic Hematopoietic Cell Transplant Survivors Through Personalized Strength Programming: A Pilot Study
- ClinicalTrials.gov ID
- NCT03609203
- Acronym / sponsor ID
- 2018NTLS073
- Conditions
- Allogeneic HCT Survivors
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Masonic Cancer Center, University of MinnesotaUniversity, hospital or other
- Study start
- 10 Sep 2018 (actual)
- Primary completion
- 31 Mar 2021 (actual)
- Study completion
- 31 Mar 2021 (actual)
- First posted
- 1 Aug 2018 (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 protocol is a pilot study of a personalized and supervised 10-week strength training program to improve self-efficacy and resolve biomarkers of inflammaging in a cohort of allogeneic hematopoietic transplant (HCT) long-term survivors versus healthy controls.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients | – | Other: 10 Weeks of Strength Trailing, Other: Group Nutrition Discussion: week 1, week 5 and week 10 |
| Controls | – | Other: 10 Weeks of Strength Trailing, Other: Group Nutrition Discussion: week 1, week 5 and week 10 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- A maximum of four pairs of patient/workout partners (8 subjects) should be actively participating in the 10-week group intervention on study at a time. Participants may sign consent at anytime but then begin group participation when spots become available.
Key inclusion criteria (19 listed)
- HCT recipients
- Healthy Controls
Key exclusion criteria (7 listed)
- Presence of an external central venous catheter (Hickman, PICC, etc); Port-a-cath devices that are completely internal are allowed
- Use of ≥ 20+ mg prednisone daily
- Current or planned use of investigational drugs during the study period
- Myocardial infarction or stroke within 6 months
- Heart failure graded Class IV on New York Heart Association (NYHA) scale (https://manual.jointcommission.org/releases/TJC2018A/DataElem0439.html)
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 |
|---|---|---|
| 10 Weeks of Strength TrailingWeek 1 (pre training session): self efficacy survey; 5-point frailty assessment*; diet survey; metabolic assessment; Functional status and body composition; blood and stool sample Week 5: self efficacy survey; Functional status and body composition Week 10: self efficacy survey; 5-point frailty assessment*; diet survey; metabolic assessment; Functional status and body composition; blood and stool samples | Other | Controls, Patients |
| Group Nutrition Discussion: week 1, week 5 and week 10Week 1 (pre training session): self efficacy survey; 5-point frailty assessment*; diet survey; metabolic assessment; Functional status and body composition; blood and stool sample Week 5: self efficacy survey; Functional status and body composition Week 10: self efficacy survey; 5-point frailty assessment*; diet survey; metabolic assessment; Functional status and body composition; blood and stool samples | Other | Controls, Patients |
Primary outcome
Self-reported outcomes of self-efficacy
Time frame: Week 10
To quantify the changes in self-reported outcomes of self-efficacy after ten weeks of strength training in patients compared to controls.
1 secondary outcome
Biomarkers of inflammaging in the blood
Time frame: Week 10
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 4 Apr 2022.
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.
Shernan G Holtan, MD principal investigator
Division of Hematology, Oncology and Transplantation, University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Allogeneic HCT Survivors, run by Masonic Cancer Center, University of Minnesota 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 19 inclusion and 7 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 4 Apr 2022. 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?
Self-reported outcomes of self-efficacy (time frame: Week 10). 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 4 Apr 2022; AzTrials last refreshed its copy on 29 Oct 2026.