Cognitive + Exercise Training for Cognitive Decline in Renal Disease

(IMPCT Trial)

No longer recruiting at 1 trial location

Overseen By Carolyn B Sidoti

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Johns Hopkins University

Disqualifiers: Pregnancy, Angina, Lung disease, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to find ways to slow memory and thinking problems in people undergoing hemodialysis, a treatment for kidney failure. Researchers are testing three approaches: cognitive training (brain games), exercise training, and a combination of both, compared to usual care. It suits English-speaking adults who began hemodialysis within the past three years at specific centers. Participants should not have conditions, such as severe heart or lung issues, that make physical activity risky. As an unphased trial, this study offers participants the chance to contribute to innovative research that could enhance the quality of life for those on hemodialysis.

Do I have to stop taking my current medications for the trial?

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that brain training exercises are generally safe and can significantly aid individuals with mild memory problems. These exercises offer long-lasting benefits, such as slowing memory loss.

Exercise programs are also safe, particularly for those with kidney disease. Studies suggest that exercise can maintain or even enhance cognitive function, ensuring it does not decline.

Combining brain and physical exercises appears promising as well. Research indicates that engaging in both can enhance physical and mental health in older adults. This combined approach has been tested and found to be safe and beneficial.

Overall, these treatments are well-tolerated, with no major safety issues reported. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments for cognitive decline in renal disease because they offer a fresh approach compared to standard care options, which typically include medications and lifestyle modifications. The combined cognitive and exercise training stands out by integrating "brain games" and physical activity, aiming to boost cognitive function through mental engagement and physical health. Cognitive training alone emphasizes brain stimulation via diverse tablet-based games, while exercise training focuses on maintaining physical activity during hemodialysis sessions using a stationary foot peddler. These methods are unique as they target cognitive decline through non-pharmacological means, potentially offering a safer, holistic alternative to traditional treatments.

What evidence suggests that this trial's treatments could be effective for cognitive decline in renal disease?

Research has shown that cognitive training (CT), which participants in this trial may receive, can effectively slow memory and thinking problems. Studies have found that CT helps maintain memory and reduces symptoms of mental decline in older adults, even those at risk. For exercise training (ET), another treatment arm in this trial, evidence indicates it can improve or maintain mental function in people undergoing hemodialysis (HD). Exercise boosts brain health and may help prevent further mental issues. Participants in this trial may also receive a combination of cognitive and exercise training (CT+ET), which has demonstrated even greater benefits. This combination can improve both physical and mental health, helping to preserve thinking abilities. ^{1 5 6 7 8}

Who Is on the Research Team?

Aarti Mathur, MD, PhD

Principal Investigator

Johns Hopkins University

Are You a Good Fit for This Trial?

This trial is for English-speaking adults over 18 who started hemodialysis between 3 months to 3 years ago at participating centers. It's not for those with severe heart or lung conditions, hepatitis B, mobility issues due to musculoskeletal conditions or amputations, blindness, orthopedic disorders worsened by exercise, or those pregnant or incarcerated.

Inclusion Criteria

I am currently receiving hemodialysis at a participating center.

English speaking

I started hemodialysis between 3 months and 3 years ago.

Exclusion Criteria

You have a type of access in your leg called femoral arteriovenous (AV) access.

I need oxygen therapy for my chronic lung condition.

My bone or joint condition gets worse with physical activity.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo cognitive training, exercise training, or combined cognitive and exercise training during hemodialysis sessions

6 months

During each hemodialysis session

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

Long-term Follow-up

Mortality and other long-term outcomes are monitored

1 year

What Are the Treatments Tested in This Trial?

Interventions

• Cognitive training
• Combined cognitive and exercise training
• Exercise training

Trial Overview The study compares three approaches—cognitive training (CT), exercise training (ET), and a combination of both (CT+ET)—against the usual care given to slow down cognitive decline in adults on hemodialysis. Participants are randomly assigned to one of these groups.

How Is the Trial Designed?

Group I: Combined cognitive and exercise training Active Control 1 Intervention

Participants in the CT+ET arm will start with 30 minutes of CT (playing "brain games" on tablet) with a 15-minute break, and then, 30 minutes of ET (stationary foot peddler).

Group II: Exercise training Active Control 1 Intervention

Participants randomized to the ET arm will be given a stationary foot peddler and will be asked to engage in the activity for a minimum of 30 minutes at each hemodialysis session for 6 months. ET will start with a 2 minute warm up, then the resistance will be adjusted so that participants are working at perceived exertion of "somewhat strong," using the Borg scale (87) (\~50 rpm). Resistance will be increased when the rating falls below "somewhat hard."

Group III: Standard of Care Active Control 1 Intervention

Participants in this arm will receive standard of care

Group IV: Cognitive training Active Control 1 Intervention

Participants randomized to CT will play "brain games" on a tablet. They will be asked to engage in the activity for a minimum of 30 minutes during each hemodialysis session for 6 months. At each HD session, participants will have 10 different brain games to play and the games will vary for each session.

Who Is Running the Clinical Trial?

Johns Hopkins University

Lead Sponsor

Trials

2,366

Recruited

15,160,000+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials

2,513

Recruited

4,366,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12321626/

Comparative efficacy of cognitive training modalities in ... In group-based interventions, RT exhibited the highest probability of cognitive improvement (77.3 %), followed sequentially by CST, MMT, MT, PC, ...

2. nature.com nature.com/articles/s41598-022-26924-2

Outcomes of a computer-based cognitive training (CoRe) ... Previous studies demonstrated the effectiveness of Cognitive Training (CT) programs in patients in the early stage of cognitive decline, i.e., ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S1041610224027133

Early intervention for cognitive decline Epidemiological and case control data support the effectiveness of cognitive training (CT) programs in healthy elderly and “at risk” older individuals ...

4. alz-journals.onlinelibrary.wiley.com alz-journals.onlinelibrary.wiley.com/doi/10.1002/dad2.12626

Five‐year effects of cognitive training in individuals with mild ... Cognitive training provides long-term benefits by mitigating memory decline and slowing clinical symptom progression in older adults with MCI.

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/29255842/

Does Cognitive Training Prevent Cognitive Decline? Cognitive training exercises are promoted to slow or prevent cognitive decline, including dementia, but their effectiveness is highly debated.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5762950/

Intradialytic Cognitive and Exercise Training May Preserve ... HD patients with cognitive impairment are at a 2.5-fold increased risk of mortality;13 in particular, worse executive function is associated with an increased ...

7. mdpi.com mdpi.com/2076-3425/13/8/1228

The Impact of Intradialytic Cognitive and Physical Training ... This study aimed to evaluate the impact on cognitive function of combining cognitive training with physical exercise and physical performance in HD patients.

8. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0022395624001936

Network meta-analysis of the effects of different cognitive ... Cognitive training can significantly improve the cognitive function of middle-aged and elderly patients with mild cognitive impairment.