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

Trial Summary

What is the purpose of this trial?

Cancer and treatment-related cognitive changes, such as thinking or remembering, hinder resumption of normal routine and roles and worsen quality of life. Older adults undergoing hematopoietic cell transplantation (HCT) are at high-risk for cognitive impairment. Age is a risk factor for Alzheimer's Dementia (AD) and the hematological malignancies leading to HCT. There are shared mechanisms and interactions between AD and cancer-related cognitive decline (CRCD). Physical activity improves cognitive function in older adults and survivors of other cancers. This study hypothesizes that increasing physical activity can also improve cognitive function in this vulnerable population. The study has two goals. The first is to adapt and test an evidence-based physical activity intervention, The Community Health Activities Model Program for Seniors II (CHAMPS II), in the HCT setting for adults 55 years and older. This will be done using semi-structured interview of up to 10 patients who have experienced the HCT process within the last 3 to 6 months with HCT care-team partners. The second goal will explore the prevalence and impact of AD-neuropathology and inflammation on cancer-related cognitive decline (CRCD) in older adults undergoing HCT.

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 data supports the effectiveness of the treatment CHAMPS-II adapted to adults 60+ years in HCT setting?

Exercise interventions have shown preliminary success in maintaining physical function in patients undergoing hematopoietic cell transplantation (HCT), suggesting that physical activity can be beneficial in this context. ^{1 2 3 4 5}

Is physical activity intervention safe for people after stem cell transplant?

Exercise interventions for people undergoing stem cell transplants have generally been safe, with no adverse events directly linked to the exercise programs in the studies reviewed. However, one serious adverse event occurred during a baseline test, not related to the exercise intervention itself, suggesting that while exercise is generally safe, individual health conditions should be considered. ^{1 3 4 5 6}

How is the CHAMPS-II treatment different from other treatments for cognitive function post-stem cell transplant?

The CHAMPS-II treatment is unique because it focuses on a physical activity intervention specifically adapted for older adults (60+ years) who have undergone stem cell transplants, aiming to improve cognitive function. Unlike other treatments that may not emphasize exercise, this program is designed to enhance physical activity levels, which can help improve overall quality of life and cognitive health in this specific patient group. ^{2 4 6 7 8}

Research Team

Thuy Koll, MD

Principal Investigator

University of Nebraska

Eligibility Criteria

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.

I am 60 or older, had a stem cell transplant in the last 3-6 months for blood cancer, and can speak English.

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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 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]

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 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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Objective and subjective physical function in allogeneic hematopoietic stem cell transplant recipients. [2023]

2. United States 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. [2013]

3. Saudi Arabia pubmed.ncbi.nlm.nih.gov

Physical Activity Compliance to American Cancer Society Recommendations Amongst Hematopoietic Stem Cell Transplant Survivors. [2023]

4. Germany pubmed.ncbi.nlm.nih.gov

Lessons learned from a pilot randomized clinical trial of home-based exercise prescription before allogeneic hematopoietic cell transplantation. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Physical Activity and Sleep Measures Using a Fitness Tracking Device during Hematopoietic Cell Transplantation: A Pilot Study. [2021]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Exercise before, during, and after Hospitalization for Allogeneic Hematological Stem Cell Transplant: A Feasibility Randomized Controlled Trial. [2020]

7. United States pubmed.ncbi.nlm.nih.gov

Steps to Enhance Early Recovery After Hematopoietic Stem Cell Transplantation: Lessons Learned From a Physical Activity Feasibility Study. [2018]

8. England pubmed.ncbi.nlm.nih.gov

A randomized control trial of a supervised versus a self-directed exercise program for allogeneic stem cell transplant patients. [2009]