Muscle Therapy for Dialysis Patients

Overseen By Natalie Isho

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Illinois at Chicago

Disqualifiers: Cardiac, Pulmonary, Unable to consent, others

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

Compensation: Varies

Number of Visits: 99

Duration: 12 months

150 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore how a specific exercise program, called the GH Method, can benefit patients with kidney issues who are on dialysis. Researchers seek to determine if regular physical activity can improve heart and body functions for those with advanced kidney disease. The trial includes a control group that won't exercise and a group that follows the exercise plan twice a week. It is suitable for individuals who have had kidney disease for a while, are currently on dialysis, or have received a kidney transplant and feel physically weak. Participants must be able to travel to the training center and follow instructions.

As an unphased trial, this study offers a unique opportunity for patients to contribute to understanding the benefits of exercise for kidney health.

Do I need to stop 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.

What prior data suggests that the GH Method is safe for dialysis patients?

Research has shown that exercise programs like the GH Method can be safe for people with chronic kidney disease (CKD). Studies have found that exercise can improve quality of life and help manage other health issues related to CKD. Participants in these studies generally handle exercise well, with few reports of serious side effects.

However, the strength of the evidence varies depending on study design and participant demographics. While specific data on the GH Method's safety in humans is limited, its focus on physical activity aligns with existing evidence suggesting exercise benefits CKD patients. For those considering joining a trial involving the GH Method, this background indicates it may be well-tolerated. Always consult healthcare professionals for advice tailored to individual health needs. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores the effects of a structured exercise intervention specifically tailored for dialysis patients, a group that typically doesn't have many exercise-focused treatment options. Unlike standard treatments that primarily focus on medication and dialysis to manage kidney disease, this method aims to improve muscle health and overall physical function through regular, guided exercise sessions. By assessing cardiovascular and functional responses over time, the study hopes to uncover new insights into how exercise can benefit dialysis patients, potentially leading to improved quality of life and better health outcomes.

What evidence suggests that the GH Method is effective for dialysis patients?

Research has shown that exercise programs like the GH Method, tested in this trial, can benefit people with kidney disease. Participants will join either an exercise intervention group or a control group. Studies have found that exercise can enhance the quality of life for those on dialysis by improving mental health and overall well-being. Other research suggests that regular physical activity might slow kidney disease progression and help manage related health issues. These benefits are crucial for people with chronic kidney disease, as exercise can improve heart health and physical ability. The GH Method aims to achieve these benefits through a specific exercise plan. ^{1 2 3 5 6}

Who Is on the Research Team?

Enrico Benedetti, MD

Principal Investigator

University of Illinois at Chicago

Are You a Good Fit for This Trial?

This trial is for patients who are weak and on dialysis, or have advanced chronic kidney disease (CKD stages 4 and 5), or are post-kidney transplant. They must be able to understand the study, consent to participate, and follow physical activity and diet instructions. Those with heart/lung diseases that make exercise unsafe or who can't travel to the training center cannot join.

Inclusion Criteria

I am on dialysis, have severe kidney issues, or had a kidney transplant.

I can understand and follow study instructions and give consent.

Exclusion Criteria

I am unable to understand and give consent for treatment.

I have heart or lung conditions that prevent me from undergoing physical training.

I cannot travel to the training center.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Baseline data collection visits to assess cardiovascular and functional responses

1 day

1 visit (in-person, 2-3 hours)

Treatment

Participants in the intervention arm perform a 12-month exercise intervention with personalized exercise rehabilitation twice a week

12 months

96 visits (in-person, 1 hour each)

Midpoint Assessment

Data collection visits at 6 months to assess changes in health and function

1 day

1 visit (in-person, 2-3 hours)

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

1 visit (in-person, 2-3 hours)

What Are the Treatments Tested in This Trial?

Interventions

• GH Method

Trial Overview The trial studies a specific physical activity program called GH Method in patients with kidney issues undergoing dialysis. It aims to see if this targeted muscle therapy improves their overall health condition.

How Is the Trial Designed?

Group I: Investigate the effects of an exercise intervention on clinically debilitated dialysis patients. Experimental Treatment 1 Intervention

150 patients from UI Health (≥ 18 years of age), who are on dialysis, or have chronic kidney disease stage 4 (CKD 4 = GFR between 15 and 29), or have chronic kidney disease stage 5 (CKD 5 = GFR below 15) and are considered clinically debilitated by their direct healthcare professional. After the initial baseline visit, subjects will come twice weekly, for roughly 1 hour each session, for 12 months (96 visits total). Subjects will also come in for data collection visits at baseline (prior to starting the exercise program), 6 months, and 12 months. Each of those visits will take about 2-3 hours. All testing done in the 3 test visits will help assess the patient's cardiovascular and functional responses and/or changes to the exercise intervention.

Group II: Control Active Control 1 Intervention

The control arm will receive no exercise intervention. Subjects will also come in for data collection visits at baseline (prior to starting the exercise program), 6 months, and 12 months. Each of those visits will take about 2-3 hours. All testing done in the 3 test visits will help assess the patient's cardiovascular and functional responses.

Who Is Running the Clinical Trial?

University of Illinois at Chicago

Lead Sponsor

Trials

653

Recruited

1,574,000+

Published Research Related to This Trial

Regular physical activity significantly benefits dialysis patients, and providing exercise opportunities at treatment centers can enhance these benefits.

Various exercise options, including in-center cycling, community walking programs, and individualized physical therapy, are effective, emphasizing the importance of a supportive treatment culture that prioritizes physical activity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

How can exercise be incorporated into the routine care of patients on dialysis? Kutner, NG.[2018]

A specially designed exercise program during hemodialysis, including low-intensity endurance training and strength exercises, has shown comparable benefits to traditional outpatient exercise programs for patients with end-stage renal failure, improving functional capacity and overall health.

This approach has been successfully implemented in about 200 German dialysis centers since 1995, with a high participation rate among patients, including the elderly and those with severe health issues, and no serious adverse effects reported, thanks to supervision by trained physiotherapists.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise during hemodialysis. Daul, AE., Schäfers, RF., Daul, K., et al.[2005]

In a study involving 7 chronic hemodialysis patients, the administration of recombinant human growth hormone (rhGH) alongside intradialytic parenteral nutrition (IDPN) and exercise led to a 22% improvement in whole-body protein balance compared to IDPN and exercise alone.

The use of rhGH also significantly reduced muscle loss of essential amino acids during the prehemodialysis period, indicating its potential as an effective anabolic therapy for improving protein and energy homeostasis in hemodialysis patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Recombinant human growth hormone improves muscle amino acid uptake and whole-body protein metabolism in chronic hemodialysis patients. Pupim, LB., Flakoll, PJ., Yu, C., et al.[2023]

The Healthy Beat Acupunch (HBA) exercise program was validated by experts as a safe and effective intervention for older adults with sarcopenia, showing improvements in gait speed after four weeks of training.

Participants in the study, which included 17 older adults, reported enjoying the program and expressed a desire to continue, indicating its feasibility and potential for enhancing well-being in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Healthy Beat Acupunch exercise program: Validation and feasibility study for older adults with reduced physical capacity or probable sarcopenia. Jones, C., Chen, KM., Weeks, B., et al.[2022]

After 12 weeks of dynamic strength training, older male subjects showed significant improvements in their maximum lifting capacities, with increases of 24% for legs and up to 54% for arms.

Training resulted in lower heart rates and blood pressure during exercise at the same absolute loads, indicating that the body's circulatory response to weight lifting is more influenced by the relative intensity of the effort rather than the absolute weight lifted.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Weight-training-induced attenuation of the circulatory response of older males to weight lifting. McCartney, N., McKelvie, RS., Martin, J., et al.[2017]

Strength training can significantly lower both systolic and diastolic blood pressure in adults with arterial hypertension, based on a systematic review of 14 studies involving 253 participants.

The most effective strength training protocols for reducing blood pressure included moderate to vigorous intensity (over 60% of one-repetition maximum), performed at least twice a week for a minimum of 8 weeks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Strength training for arterial hypertension treatment: a systematic review and meta-analysis of randomized clinical trials. Correia, RR., Veras, ASC., Tebar, WR., et al.[2023]

Aerobic or mixed exercise training significantly improves aerobic capacity in hemodialysis patients, while resistance training is more effective for increasing muscle strength, highlighting the importance of tailored exercise programs.

All types of exercise training enhance the quality of life for hemodialysis patients, but there is a need for standardized protocols and individualized goals to ensure safety and maximize adherence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise in patients on chronic hemodialysis: current evidence, knowledge gaps and future perspectives. Regolisti, G., Sabatino, A., Fiaccadori, E.[2021]

In a study involving 20 maintenance hemodialysis patients, exercising during dialysis significantly improved the removal rates of waste products like BUN and Scr compared to a control group that did not exercise.

The exercise group also showed higher levels of dialysis adequacy measures (KT/V, AUR, and SRI), suggesting that incorporating exercise into hemodialysis can enhance the overall efficiency of the treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[The effect of exercise during hemodialysis on adequacy of dialysis]. Sun, Y., Chen, B., Jia, Q., et al.[2014]

Patients with end-stage renal disease often experience malnutrition and muscle wasting, but exercise, particularly aerobic training, can help improve muscle health and nutritional status.

Functional capacity tests should be included in nutritional assessments for dialysis patients, as they provide valuable insights beyond standard nutritional evaluations and can indicate improvements in muscle function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nutritional status, functional capacity and exercise rehabilitation in end-stage renal disease. Mercer, TH., Koufaki, P., Naish, PF.[2005]

Whole-body vibration (WBV) exercises safely increased hemodynamic parameters such as heart rate and blood pressure in both sarcopenic and nonsarcopenic older adults during and after the exercise, indicating a positive cardiovascular response.

The study, involving 40 older participants, found no adverse effects from WBV exercise, suggesting it is a suitable nonpharmacological therapy for improving cardiovascular health in sarcopenic older individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Immediate Effects of Whole-Body Vibration Associated with Squatting Exercises on Hemodynamic Parameters in Sarcopenic Older People: A Randomized Controlled Trial. de Paula, FA., Mendonça, VA., Lage, VKDS., et al.[2021]

Traditional Chinese medicine (TCM), including Qigong exercises and herbal treatments, has shown a positive impact on muscle strength and physical function in older adults with sarcopenia, based on a systematic review of 21 studies involving 1,330 participants.

However, the overall quality of evidence is low due to small sample sizes and methodological issues in the studies, indicating a need for more rigorous, large-scale randomized controlled trials to confirm the efficacy of TCM for treating sarcopenia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Traditional Chinese Medicine and Sarcopenia: A Systematic Review. Guo, CY., Ma, YJ., Liu, ST., et al.[2023]

A 12-week home-based exercise program significantly improved exercise capacity (peak VO2) in 28 maintenance hemodialysis patients, demonstrating that structured exercise can enhance physical function in this population.

Participants in the exercise group also reported better general health-related quality of life, indicating that home-based exercise is a feasible and beneficial intervention for patients undergoing maintenance hemodialysis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of a Home-Based Exercise Program on Indices of Physical Function and Quality of Life in Elderly Maintenance Hemodialysis Patients. Myers, J., Chan, K., Chen, Y., et al.[2021]

A 3-month intradialytic high-intensity interval training program for nine hemodialysis patients significantly improved physical functioning, with increases in knee extensor strength and sit-stand test performance, but did not lead to changes in lean mass or insulin-like growth factor levels.

The exercise program was found to be safe and clinically feasible, highlighting the need for further research into additional anabolic treatments to address muscle wasting in patients with end-stage renal disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intradialytic exercise as anabolic therapy in haemodialysis patients -- a pilot study. Macdonald, JH., Marcora, SM., Jibani, M., et al.[2006]

A 6-month personalized walking exercise program for patients with kidney failure significantly reduced the long-term risk of hospitalization or death by 29% during a follow-up of up to 36 months, based on data from 227 participants.

Patients who adhered to the exercise program (attending more than 60% of sessions) experienced an even greater benefit, with a 45% lower risk of hospitalization or death compared to the control group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-Term Effect of Physical Exercise on the Risk for Hospitalization and Death in Dialysis Patients: A Post-Trial Long-Term Observational Study. Mallamaci, F., D'Arrigo, G., Tripepi, G., et al.[2023]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06374537

NCT06374537 | Evaluate the Impact of Targeted Physical ... This research is being done to better understand the impact of the use of a specific physical activity training program (GH Method) in dialysis/kidney ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12165990/

The effect of exercise training on quality of life in people ... This study aimed to determine the effect of exercise training on health-related QoL in individuals with CKD requiring dialysis, focusing on mental health ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S246802492401862X

Review of Exercise Interventions to Improve Clinical ... The potential benefits of exercise training in CKD range from slowing disease progression to improving comorbidities and quality of life.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11649798/

The effect of exercise training in people with pre-dialysis ... This review examines the impact of exercise on CKD patients not on dialysis, focusing on improvement in various health parameters.

5. kireports.org kireports.org/article/S2468-0249(24)01862-X/fulltext

Review of Exercise Interventions to Improve Clinical ... The potential benefits of exercise training in CKD range from slowing disease progression to improving comorbidities and quality of life.

6. trial.medpath.com trial.medpath.com/clinical-trial/60f4f4d379378bb3/nct06374537-evaluating-impact-physical-activity-dialysis-patients

Evaluate the Impact of Targeted Physical Activity on Clinically ... This research is being done to better understand the impact of the use of a specific physical activity training program (GH Method) in dialysis/kidney disease ...