Physical Activity Intervention for Cognitive Function Post-Stem Cell Transplant

(PROACTIVE Trial)

Overseen By Marcia M Free, BSN

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Thuy Koll MD

Disqualifiers: Heart disease, Stroke, Multiple sclerosis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

88 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if increasing physical activity can enhance thinking and memory in older adults who have undergone a stem cell transplant for blood cancer. Participants will engage in a specially adapted exercise program (CHAMPS-II, tailored for adults aged 60 and older in an HCT setting) to assess its impact on cognitive function. The study also examines how Alzheimer's disease factors and inflammation may influence memory issues related to cancer treatments. This trial is ideal for individuals aged 55 and older who have had a stem cell transplant in the past 3 to 6 months and can walk a short distance. As an unphased trial, it offers a unique opportunity to contribute to understanding the benefits of exercise on cognitive health post-transplant.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this physical activity intervention is safe for older adults post-stem cell transplant?

Studies have shown that the CHAMPS-II physical activity program is generally well-tolerated by older adults. This program allows seniors to choose their own physical activities, making it flexible and easier to follow. Although specific data on side effects for this version in the HCT setting is unavailable, older people have safely used the original CHAMPS-II program. This suggests that the adapted program could also be safe. Overall, programs like this have a good safety record for seniors. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the adapted CHAMPS-II physical activity program because it focuses on enhancing cognitive function for adults over 60 who have undergone stem cell transplants. Unlike traditional cognitive therapies that might rely on medication or cognitive exercises alone, this intervention incorporates physical activity tailored to the unique needs of this group. The program is not only expected to improve cognitive outcomes but also engages the patients' care-partners and healthcare team, providing a holistic approach to recovery and feedback. This comprehensive and interactive method has the potential to offer a more engaging and effective path to cognitive recovery compared to existing options.

What evidence suggests that the adapted CHAMPS-II intervention is effective for improving cognitive function post-stem cell transplant?

Research shows that exercise can boost brain function in older adults, including cancer survivors. Early data indicates that after a stem cell transplant, 35% of older patients face serious memory and thinking issues, compared to 19% before the transplant. In this trial, the CHAMPS-II program, a physical activity plan aimed at improving memory and thinking skills in seniors, has been specially adapted for older adults who have undergone hematopoietic cell transplantation (HCT). Initial studies suggest that increased activity can help reduce memory and thinking problems in this group, possibly enhancing their quality of life. Participants in this trial will either receive the adapted CHAMPS-II intervention immediately or after a wait period, allowing researchers to assess its effectiveness. ^{1 2 6 7 8}

Who Is on the Research Team?

Thuy Koll, MD

Principal Investigator

University of Nebraska

Are You a Good Fit for This Trial?

This trial is for older adults aged 60+ who have hematological malignancies like lymphoma or leukemia and are undergoing stem cell transplant. They must be able to walk a short distance, speak English, and consent to participate. Care-partners of these patients can also join if they meet similar criteria.

Inclusion Criteria

I am 19 or older and can speak and read English.

I am 60 or older, diagnosed with blood cancer, and can walk 4 meters. I agree to follow the study's physical activity plan.

Exclusion Criteria

You experience chest pain, severe shortness of breath, or any other safety concerns during physical activities, and have not been cleared by a doctor to exercise. You have medical, psychiatric, or behavioral factors that may interfere with participating in the study or following the study's requirements.

My care-partner is not cleared for exercise due to health concerns or has conditions that interfere with study participation.

Transplant Team Member: no exclusion criteria

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Preliminary Adaptation

Participants provide feedback on the CHAMPS-II intervention and survivorship education materials through qualitative interviews.

3-6 months

Interviews with participants, care-partners, and HCT team members

Treatment

Participants engage in the adapted CHAMPS-II physical activity program to improve cognitive function.

12 weeks

Regular sessions as per CHAMPS-II program

Follow-up

Participants are monitored for changes in cognitive function and physical activity outcomes.

12 weeks

What Are the Treatments Tested in This Trial?

Interventions

• CHAMPS-II adapted to adults 60+ years in HCT setting
• Survivorship education active control

Trial Overview The trial tests an adapted physical activity program called CHAMPS-II, designed to improve cognitive function in seniors post-stem cell transplant. Participants will engage in light to moderate exercises until Day 100 post-transplant compared with a wait-list control group.

How Is the Trial Designed?

Group I: Adapted CHAMPS-II intervention Experimental Treatment 1 Intervention

All participants in Aim 2 (preliminary testing) and Aim 3 (RCT) will participate in the CHAMPS-II physical activity program adapted to the HCT setting. Testing for outcome measures will be completed, and feedback on the intervention will be obtained via qualitative interviews from 1)adult participants 60+ years receiving HCT, 2)participants' care-partner, and 3)HCT team members. Aim 3 participants will be randomized to either the immediate intervention (intervention then follow-up) or delayed intervention (wait period and then intervention).

Group II: Feedback for Preliminary Adaptation Active Control 1 Intervention

Participants in Aim 1 will participate in qualitative interviews to obtain feedback on the CHAMPS-II intervention and survivorship education active control condition materials. Interviews will be with 1)adult participants 60+ years who have recently undergone HCT, 2)participants' care-partner, and 3)HCT team members.

Who Is Running the Clinical Trial?

Thuy Koll MD

Lead Sponsor

Trials

1

Recruited

90+

University of Nebraska

Lead Sponsor

Trials

563

Recruited

1,147,000+

Published Research Related to This Trial

A study of 81 hematopoietic cell transplantation (HCT) survivors found that 83% did not meet the American Cancer Society's recommendation of over 500 MET minutes of physical activity per week, indicating a significant gap in adherence to physical activity guidelines.

Only 17.3% of participants met the recommended activity levels, highlighting the need for improved screening and counseling in HCT survivorship care to promote a more active lifestyle.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical Activity Compliance to American Cancer Society Recommendations Amongst Hematopoietic Stem Cell Transplant Survivors. Mead, LE., Kelly, DL., Dahl, WJ., et al.[2023]

A feasibility randomized controlled trial involving patients undergoing allogeneic hematological stem cell transplant (allo-HSCT) showed that an exercise program delivered before, during, and after the transplant was safe, with no adverse events linked to the exercise intervention.

Participants in the exercise group improved their six-minute walk test distances by an average of 45 meters before the transplant, suggesting that exercise may enhance physical function in this patient population and warrants further research with larger studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise before, during, and after Hospitalization for Allogeneic Hematological Stem Cell Transplant: A Feasibility Randomized Controlled Trial. Santa Mina, D., Dolan, LB., Lipton, JH., et al.[2020]

In a study of 47 adult patients who underwent allogeneic hematopoietic cell transplantation (HCT), physical function was assessed before and after the procedure, revealing that patients were largely sedentary, spending a median of 6 hours daily inactive post-transplant.

The 6-minute walk test (6MWT) conducted on day +30 post-HCT was strongly associated with survival outcomes, indicating that early physical function assessments can help predict long-term mortality risks in HCT recipients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Objective and subjective physical function in allogeneic hematopoietic stem cell transplant recipients. Mishra, A., Pidala, J., Thapa, R., et al.[2023]

In a study of 61 allogeneic stem cell transplant patients, both therapist-supervised and patient-directed exercise programs led to significant improvements in physical performance, with the supervised group showing slightly better results in walking distances after 4 weeks of training.

Both groups experienced a reduction in fatigue levels, although this change was not statistically significant, indicating that exercise can be beneficial for functional outcomes in transplant patients regardless of supervision style.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized control trial of a supervised versus a self-directed exercise program for allogeneic stem cell transplant patients. Shelton, ML., Lee, JQ., Morris, GS., et al.[2009]

A study involving 83 patients undergoing hematopoietic cell transplantation (HCT) found that physical activity significantly declines during hospital admission, with allogeneic HCT patients being less active than those undergoing autologous HCT.

Despite the decline in physical activity, the study revealed that this decrease did not correlate with HCT-related outcomes such as readmission or survival, indicating that while activity levels drop, they may not impact recovery as previously thought.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical Activity and Sleep Measures Using a Fitness Tracking Device during Hematopoietic Cell Transplantation: A Pilot Study. Jurdi, NE., Nock, N., Fu, P., et al.[2021]

A pilot study tested a 5- to 12-week home-based aerobic exercise program for patients preparing for allogeneic hematopoietic cell transplantation (alloHCT), but it did not show significant improvements in physical function measures like peak oxygen consumption (VO2peak) or 6-minute walk distance (6MWD).

The small number of participants (34 randomized, with only 16 and 12 evaluable for VO2peak and 6MWD, respectively) limited the ability to draw strong conclusions about the efficacy of the exercise intervention, indicating that future studies need better design and participant recruitment strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lessons learned from a pilot randomized clinical trial of home-based exercise prescription before allogeneic hematopoietic cell transplantation. Wood, WA., Weaver, M., Smith-Ryan, AE., et al.[2021]

The pilot study showed that a free-living physical activity intervention after hematopoietic stem cell transplantation is feasible and acceptable, with participants meeting their activity goals 57% of the time over 6 weeks.

Participants experienced a significant reduction in physical fatigue after the intervention, and improvements in quality of life were noted, suggesting potential benefits of early physical activity in recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Steps to Enhance Early Recovery After Hematopoietic Stem Cell Transplantation: Lessons Learned From a Physical Activity Feasibility Study. Hacker, ED., Peters, T., Patel, P., et al.[2018]

Eighteen adolescent and young adult patients undergoing hematopoietic stem cell transplant engaged in exercise during hospitalization, averaging 76% of days and 36.5 minutes per day, primarily using standard activities like walking and resistance training.

Despite high participation rates in exercise, there were no improvements in functional capacity or quality of life, indicating that supervision and structured programs may be necessary to enhance the benefits of exercise for these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessment of voluntary exercise behavior and active video gaming among adolescent and young adult patients during hematopoietic stem cell transplantation. Rosipal, NC., Mingle, L., Smith, J., et al.[2013]

Citations

1. reporter.nih.gov reporter.nih.gov/project-details/11177811

Promoting Physical Activity to Improve Cognitive Function in Older ... Our preliminary data shows that post-HCT, 35% of older patients experience significant cognitive impairment compared to 19% pre-HCT. Physical activity improves ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT04898790

Improving Cognitive Function in Older Adults Undergoing ... Improving Cognitive Function in Older Adults Undergoing Stem Cell Transplant (PROACTIVE) ... CHAMPS-II physical activity program adapted to the HCT setting.

3. reporter.nih.gov reporter.nih.gov/search/FYlCILr1jEyDXP_FRmwhJA/project-details/11177811

Promoting Physical Activity to Improve Cognitive Function in Older ... Our preliminary data shows that post-HCT, 35% of older patients experience significant cognitive impairment compared to 19% pre-HCT. Physical activity improves ...

4. withpower.com withpower.com/trial/phase-multiple-myeloma-6-2021-9abe5?condition=Leukemia&overallStatus=Recruiting&hasNoPlacebo=true

Physical Activity Intervention for Cognitive Function Post-Stem ... Trial Overview The trial tests an adapted physical activity program called CHAMPS-II, designed to improve cognitive function in seniors post-stem cell ...

5. centerwatch.com centerwatch.com/clinical-trials/listings/NCT04898790/improving-cognitive-function-in-older-adults-undergoing-stem-cell-transplant

Improving Cognitive Function in Older Adults Undergoing ... Investigators will adapt CHAMPS II, an evidence-based physical activity intervention, to the HCT setting for older adults to improve cognitive ...

6. ebccp.cancercontrol.cancer.gov ebccp.cancercontrol.cancer.gov/programDetails.do?programId=207001

Community Healthy Activities Model Program for Seniors ... This individually tailored, choice-based physical activity program promotes increased long-term physical activity levels in older adults.

7. reporter.nih.gov reporter.nih.gov/search/_u-rnfOrskeyCX1PCObWMA/project-details/10917065

RePORT ⟩ RePORTER We're sorry but RePORTER doesn't work properly without JavaScript enabled. Please enable it to continue.

8. cadc.ucsf.edu cadc.ucsf.edu/champs

CHAMPS Physical Activity Questionnaire for Older Adults This unique program aimed to increase physical activity levels of seniors by encouraging them to participate in physical activities of their choice, based on ...