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

Trial Summary

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 data supports the effectiveness of the treatment GH Method, Targeted Physical Activity Program for dialysis patients?

Research shows that regular exercise, including aerobic and resistance training, can improve muscle strength, quality of life, and reduce hospitalization risk in dialysis patients. A home-based exercise program has been effective in reversing muscle wasting and improving physical function in these patients. ^{1 2 3 4 5}

Is the Muscle Therapy for Dialysis Patients treatment generally safe for humans?

Research on similar exercise programs, like whole-body vibration and strength training, shows they are generally safe for older adults, including those with sarcopenia (muscle loss with aging) and hypertension (high blood pressure), without adverse effects on the heart or blood pressure. ^{6 7 8 9 10}

How is the GH Method treatment different from other treatments for dialysis patients?

The GH Method, a targeted physical activity program, is unique because it is designed to be performed during dialysis sessions, combining low-intensity endurance exercises, strength training, and relaxation techniques, which can improve muscle function and dialysis efficiency without requiring patients to attend separate exercise sessions. ^{4 11 12 13 14}

What is the purpose of this trial?

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 patients.

Research Team

Enrico Benedetti, MD

Principal Investigator

University of Illinois at Chicago

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

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]

References

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

Exercise in patients on chronic hemodialysis: current evidence, knowledge gaps and future perspectives. [2021]

2. China pubmed.ncbi.nlm.nih.gov

[The effect of exercise during hemodialysis on adequacy of dialysis]. [2014]

3. United States 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. [2023]

4. Switzerland 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. [2021]

5. Germany pubmed.ncbi.nlm.nih.gov

Nutritional status, functional capacity and exercise rehabilitation in end-stage renal disease. [2005]

6. Switzerland 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. [2021]

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

Healthy Beat Acupunch exercise program: Validation and feasibility study for older adults with reduced physical capacity or probable sarcopenia. [2022]

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

Weight-training-induced attenuation of the circulatory response of older males to weight lifting. [2017]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Traditional Chinese Medicine and Sarcopenia: A Systematic Review. [2023]

10. England pubmed.ncbi.nlm.nih.gov

Strength training for arterial hypertension treatment: a systematic review and meta-analysis of randomized clinical trials. [2023]

11. England pubmed.ncbi.nlm.nih.gov

Intradialytic exercise as anabolic therapy in haemodialysis patients -- a pilot study. [2006]

12. Netherlands pubmed.ncbi.nlm.nih.gov

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

13. Germany pubmed.ncbi.nlm.nih.gov

Exercise during hemodialysis. [2005]

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

Recombinant human growth hormone improves muscle amino acid uptake and whole-body protein metabolism in chronic hemodialysis patients. [2023]