Home-Based Exercise for Diabetes & Chronic Kidney Disease
(Fantastic Trial)
Recruiting in Palo Alto (17 mi)
Overseen byDiana Mager, PhD MSc RD
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of Alberta
Disqualifiers: Functional impairments, Cognitive impairments, Vision loss, others
No Placebo Group
Trial Summary
What is the purpose of this trial?One of the most common problems in people with diabetes (DM) and chronic kidney disease (CKD) is the high frequency of other coinciding medical conditions such as osteoporosis and frailty. Frailty in particular is very common in adults with DM and CKD and it can result in significant muscle weakness which can result in increasing difficulties with performing activities of daily life (ADL). This can lead to an increase risk for falls, bone fractures and increasing hospitalization. The investigators have showed that adults with DM and CKD who have frailty use hospital services more frequently, have reduced quality of life and difficulties with performing their ADLs1. There is some evidence that early screening for frailty and lifestyle interventions that focus on healthier eating and physical activity can help prevent frailty from getting worse. The study purpose is to develop and test a home-based lifestyle intervention program focused on optimizing diet and the ability to perform your ADLs in adults with DM and CKD. The goal of this program is to ensure that adults with DM can live healthier lives within the community.
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 is best to discuss this with the trial coordinators or your doctor.
What data supports the effectiveness of the treatment Resistance Exercise, Resistance Training, Strength Training for diabetes and chronic kidney disease?
Research shows that resistance exercise can improve muscle mass, strength, and physical function, which are beneficial for people with chronic kidney disease. It may also help with better glucose control and improve overall quality of life, making it a promising treatment for those with diabetes and kidney issues.
12345Is resistance exercise safe for people with chronic kidney disease?
Resistance exercise is generally safe for people with chronic kidney disease, as studies show it can improve muscle strength and quality of life without causing side effects like injuries or hospitalizations.
25678How is resistance exercise unique as a treatment for diabetes and chronic kidney disease?
Resistance exercise is unique because it focuses on building muscle strength and size, which can improve physical function and quality of life for patients with chronic kidney disease and diabetes. Unlike other treatments, it may also help with nutritional status, insulin sensitivity, and overall well-being, making it a noninvasive and cost-effective option.
2691011Eligibility Criteria
This trial is for adults aged 50-85 with Type 2 diabetes and moderate chronic kidney disease (not on dialysis). Participants should be able to perform resistance exercises and have no severe cognitive impairments, vision loss, recent bone fractures, or muscular disorders that limit mobility.Inclusion Criteria
I am between 50 and 85 years old.
I have Type 2 diabetes and my kidney function is reduced but not severely.
Exclusion Criteria
You have difficulties with thinking and remembering things.
I cannot do exercises like walking or standing up from a chair due to severe joint issues.
I am on dialysis for kidney disease.
+3 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
1 visit (in-person)
Development of Video Programming
Home video content is developed focusing on resistance exercise and nutrition literacy
2 months
Open-label Non-blinded Study
Participants undergo frailty screening and are randomized to intervention or control groups
6 months
Baseline and 6-month visits (in-person), monthly home visits
Follow-up
Participants are monitored for changes in frailty status, cognitive health, and quality of life
6 months
Participant Groups
The study is testing a home-based lifestyle program aimed at improving diet and daily activity in adults with diabetes and kidney disease. The goal is to prevent frailty-related issues like muscle weakness, falls, fractures, and hospitalizations.
4Treatment groups
Experimental Treatment
Active Control
Group I: Exercise Intervention Pre-FrailExperimental Treatment1 Intervention
Resistance Exercise Intervention (home video education: resistance training and diet education) for Pre-Frail participants
Group II: Exercise Intervention FrailExperimental Treatment1 Intervention
Resistance Exercise Intervention (home video education: resistance training and diet education) for Frail participants
Group III: Standard of Care or Control FrailActive Control1 Intervention
Standard of Care (standard diet and physical activity education) for Frail Participants
Group IV: Standard of Care or Control Pre-FrailActive Control1 Intervention
Standard of Care (standard diet and physical activity education) for Pre-Frail Participants
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Diabetic Nephropathy Prevention Clinic - Alberta Kidney Care - NorthEdmonton, Canada
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Who Is Running the Clinical Trial?
University of AlbertaLead Sponsor
References
Home-based aerobic exercise and resistance training for severe chronic kidney disease: a randomized controlled trial. [2022]Label="BACKGROUND">The potential effects of aerobic and resistance training in patients with severe chronic kidney disease (CKD) are not fully elucidated. This study investigated the effects of a home-based exercise programme on physical functioning and health-related quality of life (HRQOL) in patients with Stage 4 CKD, equivalent to estimated glomerular filtration rate of 15-30 mL/min/1.73 m2 .
Potential benefits of resistance exercise training on nutritional status in renal failure. [2019]Resistance or strength exercise training may help reverse the malnutrition common among patients in chronic renal failure and delay the progression of renal disease. Resistance training is characterized by resisting, lifting, and lowering weights. It results in muscle mass accretion, improved physical function, and slowed progression of muscle wasting. Resistance exercise training for a period of 8 to 12 weeks results in significant increases in muscle mass, muscle strength, and muscle function in frail "healthy" elderly individuals as well as in specific patient populations. States of malnutrition leading to muscle wasting directly affect lean tissue mass and functional capacity. Even at dietary protein intake below the Recommended Dietary Allowances, resistance training appears to exert an anabolic effect by improving energy intake and protein use allowing nitrogen retention. The potential benefits of resistance exercise extend beyond this direct impact on protein metabolism. They include improvements in functional capacity such as gait, balance, mobility, strength, exercise tolerance, improved glucose uptake, insulin sensitivity, and self-efficacy and self-esteem. Currently, the effects of resistance exercise in renal patients are unknown, although they are well shown in the case of other diseases. The potential benefits that resistance exercise training may have on muscle mass and function, nutritional status, hyperglycemia, disease progression, and the overall mental well-being of renal patients deserve further investigation. As an adjunct to current treatment modalities for chronic renal failure, resistance exercise may serve as a cost-effective, interdisciplinary, noninvasive approach to counteract malnutrition and improve the quality of life.
Advancing Exercise Science for Better Health Outcomes Across the Spectrum of Chronic Kidney Disease. [2023]Despite over 30 years of evidence for improvements in physical function, physical fitness, and health-related quality of life with exercise training in individuals with chronic kidney disease, access to dedicated exercise training programs remains outside the realm of standard of care for most kidney care programs. In this review, we explore possible reasons for this by comparing approaches in other chronic diseases where exercise rehabilitation has become the standard of care, identifying enablers and factors that need to be addressed for continued growth in this area, and discussing knowledge gaps for future research. For exercise rehabilitation to be relevant to all stakeholders and become a sustainable component of kidney care, a focus on the effect of exercise on clinically relevant outcomes that are prioritized by individuals living with kidney disease, use of evidence-based implementation strategies for diverse settings and populations, and approaching exercise as a medical therapy are required.
Exercise as a therapeutic intervention in chronic kidney disease: are we nearly there yet? [2023]The opportunity to review the more recent evidence for prescribing exercise-based physical rehabilitation for people living with chronic kidney disease (CKD) is timely. There has been a recent global focus evaluating how physical activity interventions might improve health-related quality of life and outcomes for people living with chronic health conditions in a post-COVID era. There is finally a long overdue commitment from the kidney research and clinical community to deliver pragmatic interventions to help people living with CKD to be able to live well with their condition.
Home-Based Exercise for People With Chronic Kidney Disease: A Systematic Review and Meta-Analysis. [2022]Exercise performed at home could be a useful therapy for people with chronic kidney disease. This systematic review and meta-analysis aimed at describing the characteristics, main findings, methodological quality, and adherence rate reported in the existent randomized controlled trials that have provided information regarding the impact of home-based exercise programs on people with chronic kidney disease.
A comparison of aerobic exercise and resistance training in patients with and without chronic kidney disease. [2022]The morbidity and mortality associated with chronic kidney disease (CKD) are primarily caused by atherosclerosis and cardiovascular disease, which may be in part caused by inflammation and oxidative stress. Aerobic exercise and resistance training have been proposed as measures to combat obesity, inflammation, endothelial dysfunction, oxidative stress, insulin resistance, and progression of CKD. In non-CKD patients, aerobic exercise reduces inflammation, increases insulin sensitivity, decreases microalbuminuria, facilitates weight loss, decreases leptins, and protects against oxidative injury. In nondialysis CKD, aerobic exercise decreases microalbuminuria, protects from oxidative stress, and may increase the glomerular filtration rate (GFR). Aerobic exercise in hemodialysis patients has been reported to enhance insulin sensitivity, improve lipid profile, increase hemoglobin, increase strength, decrease blood pressure, and improve quality of life. Resistance training, in the general population, decreases C-reactive protein, increases insulin sensitivity, decreases body fat content, increases insulin-like growth factor-1 (IGF-1), and decreases microalbuminuria. In the nondialysis CKD population, resistance training has been reported to reduce inflammation, increase serum albumin, maintain body weight, increase muscle strength, increase IGF-1, and increase GFR. Resistance training in hemodialysis increases muscle strength, increases physical functionality, and improves IGF-1 status. Combined aerobic exercise and resistance training during dialysis improves muscle strength, work output, cardiac fitness, and possibly dialysis adequacy. There is a need for more investigation on the role of exercise in CKD. If the benefits of aerobic exercise and strength training in non-CKD populations can be shown to apply to CKD patients as well, renal rehabilitation will begin to play an important role in the approach to the treatment, prevention, and slowed progression of CKD.
A Trial of Lifestyle Modification on Cardiopulmonary, Inflammatory, and Metabolic Effects among Obese with Chronic Kidney Disease. [2018]The feasibility and benefits of lifestyle intervention in chronic kidney disease (CKD) patients who are obese has not been well studied. We examined the early effects of an exercise plus weight loss intervention on body composition, exercise capacity, metabolic parameters and kidney function in obese subjects with CKD.
Effects of a resistance training program in kidney transplant recipients: A randomized controlled trial. [2021]Kidney transplant recipients are at risk of developing important adverse effects after transplantation. The objective of this study was to investigate the effects of a 10-week supervised resistance exercise-based intervention in kidney transplant recipients. Sixteen participants were randomized to a training (n = 8, 49.7 ± 9.6 years) or control group (n = 8, 48.6 ± 10.6 years). The primary endpoint was health-related quality of life evaluated through the Kidney Disease Quality of Life-Short Form (KDQOL-SF), which includes the 36-Item Short Form Survey (SF-36), and secondary endpoints included physical performance (6-minute walk distance [6-MWD], 60-second sit to stand test [60-STS], 8-foot up and go test, and handgrip and lower limb muscle strength), muscle mass, and biochemical parameters. Endpoints were assessed at baseline and after 10 weeks. Resistance exercise significantly increased (P .05) were found for the remaining endpoints. There were no adverse events, musculoskeletal injuries, hypoglycemic episodes, cardiovascular events, or hospitalizations related to the intervention. In conclusion, 10 weeks of supervised resistance training is enough to improve quality of life and physical performance without side effects such as musculoskeletal injuries, hypoglycemic episodes, cardiovascular events, or hospitalizations related to the intervention in kidney transplant recipients.
Resistance training in hemodialysis patients: a review. [2015]Few studies have examined the role of resistance training (RT) in chronic kidney patients on hemodialysis (HD). This study reviews the literature about resistance exercise for patients on HD and describes protocols and clinical outcomes.
[Effect of resistance exercise intradialytic in renal patients chronic in hemodialysis]. [2019]Patients with chronic kidney disease (CKD) when subjected to resistance exercise (RE) show substantial improvements in many functions, especially those related to the cardiovascular system, respiratory, muscular and quality of life (QOL). There are no evaluations of the impact of exercise simple and feasible in patients with CKD associated with Diabetes Mellitus (DM) during the intradialytic period. Thus, patients with CKD and submit to the DM + RE during hemodialysis.
Exercise and chronic kidney disease: current recommendations. [2022]Patients with chronic kidney disease (CKD) are inactive and have reduced physical functioning and performance. Aerobic exercise interventions have been shown to increase maximal oxygen consumption in selected patients. In addition, preliminary evidence, although mixed, suggests that aerobic exercise training can improve blood pressure control, lipid profiles and mental health in this population. A few larger studies are now available showing that aerobic training can also improve physical functioning and performance. The impact on survival or hospitalisation has not been determined. Resistance exercise training, although less studied, appears to increase muscle strength and size and may also improve functioning. There have been several reports of successful combined exercise interventions, but the designs have not allowed evaluation of the relative benefits of aerobic and resistance training on physical functioning. Despite the evidence that exercise is safe and beneficial in patients with CKD, dialysis patients remain inactive, and exercise assessment, counselling and training is not widely offered to patients with CKD. Studies of the barriers to patient participation in exercise and to provider assessment and recommendations are needed so that more widely generalisable interventions can be developed. However, in the interim, patients should be encouraged to participate in moderate physical activity to meet the US Surgeon General's recommendations. Patients who are weak can benefit from strength-training interventions. Resistance and aerobic exercise programmes should be initiated at relatively low intensity in patients with CKD and progressed as slowly as tolerated in order to avoid injury and discontinuation of exercise. For patients on haemodialysis, incorporation of exercise into the dialysis session may increase patient participation and tolerance of exercise.