Fight Fatigue for Kidney Failure

Overseen By Mary Hannan, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Illinois at Chicago

Disqualifiers: Unstable angina, Unstable pulmonary, Amputation, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to ease fatigue in adults with severe kidney disease undergoing regular dialysis. It combines muscle relaxation exercises and walking to determine if these activities can reduce tiredness. Participants will be divided into two groups: one will try the new program called "Fight Fatigue," while the other will receive education about kidney disease. Candidates may qualify if they have been on dialysis for at least three months, often feel tired, and can walk a block. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could enhance the quality of life for dialysis patients.

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 intervention is safe for adults with end-stage kidney disease?

Research has shown that exercise and relaxation techniques are generally safe for people on dialysis. Studies of similar programs have found that participants handle them well. For instance, research on exercise for dialysis patients showed it improved health without causing major side effects. Progressive muscle relaxation, included in this trial, has been safely used in other kidney disease groups. Another study found that combining relaxation with mindfulness did not lead to serious issues. These findings suggest that the treatment in this trial is likely safe for participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Fight Fatigue program for kidney failure because it combines progressive muscle relaxation with increasing physical activity, specifically through walking. Unlike standard treatments that focus on medication or dialysis to manage symptoms, this approach emphasizes lifestyle changes that can empower patients to take an active role in their well-being. The intervention also includes education and supportive text messages, offering a holistic strategy that addresses both physical and mental health aspects of fatigue. This innovative method could provide a non-invasive, sustainable way to manage fatigue, potentially improving patients' quality of life significantly.

What evidence suggests that this intervention is effective for reducing fatigue in end-stage kidney disease?

This trial will compare a combined progressive muscle relaxation and walking intervention with an attention control group. Studies have shown that progressive muscle relaxation can reduce tiredness in people on dialysis. This method, combined with walking, may slow or prevent the worsening of kidney disease. Early findings suggest that this type of exercise could effectively combat fatigue. Research also shows that patients and caregivers consider exercise important for improving well-being during kidney treatments. While more information is needed, these early results suggest a positive effect on energy levels. ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

This trial is for adults with end-stage kidney disease (ESKD) who feel very tired, can walk at least one block, have a cell phone to receive texts, and speak English. They should be on hemodialysis for 3+ months but not if they're unable to follow the study procedures.

Inclusion Criteria

I have felt very tired, with a fatigue score of 4 or more in the past week.

Can read and speak English

I can walk one block without help.

Exclusion Criteria

Participation in the formative phase of the development of Fight Fatigue

I do not have any cognitive issues that would stop me from joining the trial.

I have had a leg amputation and do not use a prosthetic.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo a 12-week intervention involving progressive muscle relaxation and walking, with education/training and text message support

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Fight Fatigue

Trial Overview The 'Fight Fatigue' trial tests whether doing muscle relaxation exercises and walking can help reduce fatigue in people with ESKD on hemodialysis. Participants will either get regular care or do these activities as part of the study.

How Is the Trial Designed?

Group I: Fight Fatigue Experimental Treatment 1 Intervention

Combined progressive muscle relaxation and walking (increasing step count) 12-week intervention that consists of education/training followed by text messages

Group II: Attention Control Active Control 1 Intervention

End-stage kidney disease education, followed by text messages (over 12 weeks)

Who Is Running the Clinical Trial?

University of Illinois at Chicago

Lead Sponsor

Trials

653

Recruited

1,574,000+

National Center for Complementary and Integrative Health (NCCIH)

Collaborator

Trials

886

Recruited

677,000+

Citations

1. reporter.nih.gov reporter.nih.gov/project-details/11039297

Fight Fatigue: A progressive muscle relaxation and walking ... Findings from this study will provide the necessary data to design and test a large- scale efficacy trial to reduce fatigue for adults with ESKD and thus ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT07014111

Fight Fatigue: A Progressive Muscle Relaxation and ... Fight Fatigue is evaluating the feasibility and acceptability of a combined progressive muscle relaxation and walking intervention to reduce fatigue for adults ...

3. mdpi.com mdpi.com/2673-8236/5/2/25

The Effects of Exercise Training Interventions on Dialysis ... The results showed that progressive muscle relaxation had a better effect on all the considered outcomes [17]. The lack of trials evaluating home-based physical ...

4. academic.oup.com academic.oup.com/ckj/article/14/3/831/5722188

Patient-led identification and prioritization of exercise ... Patients and caregivers believed that exercise would slow or prevent bodily deterioration due to dialysis and end-stage kidney disease. Some ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10468823/

Interventions for fatigue in people with kidney failure requiring ... We aimed to evaluate the effects of pharmacological and non‐pharmacological interventions on fatigue in people with kidney failure receiving dialysis.

6. jnsw.kidney.org jnsw.kidney.org/index.php/jnsw/article/view/44/43

View of Relaxation Therapy and Mindfulness Meditation One ... End-stage renal disease (ESRD) requires ongoing dialysis treatment or kidney ... Body Scan, Progressive Muscle Relaxation, Safe Place Visualization ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11100145/

The influence of mindfulness meditation combined with ... This study aimed to observe the effect of mindfulness meditation combined with progressive muscle relaxation training on the clinical efficacy ...

8. academic.oup.com academic.oup.com/eurjpc/article/31/12/1493/7642937

role of exercise training on cardiovascular risk factors and ... The data showed that any type of exercise significantly increased aerobic capacity in patients with CKD G2–G5 on HD and in patients with a kidney transplant.11 ...