Home-Based Exercise for Diabetes & Chronic Kidney Disease

(Fantastic Trial)

Overseen By Diana Mager, PhD MSc RD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Alberta

Disqualifiers: Functional impairments, Cognitive impairments, Vision loss, others

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

Compensation: Varies

Number of Visits: 7

120 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to assist individuals with both Type 2 diabetes and chronic kidney disease (CKD) who experience frailty, which can hinder daily activities and increase fall risk. Researchers seek to determine if a home-based program focused on resistance exercises (also known as resistance or strength training) and diet can enhance strength and quality of life. Participants will either continue with standard care or engage in the new exercise and diet routine through home video education. This trial suits adults diagnosed with Type 2 diabetes and early to mid-stage CKD who face muscle weakness impacting their daily life. As an unphased trial, it offers a unique opportunity to explore innovative methods to improve daily living and well-being.

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 prior data suggests that this home-based exercise program is safe for adults with diabetes and chronic kidney disease?

Research shows that resistance exercise is generally safe for people with chronic kidney disease (CKD) and diabetes. Studies have found that it can boost physical abilities, improve metabolism, and benefit heart health. One study specifically noted that resistance training enhances heart health in adults, regardless of heart disease presence. Another study highlighted improvements in quality of life and potential slowing of CKD progression.

Negative effects from resistance training are rare. A review found only a small number of significant issues related to this type of exercise, indicating that most people handle it well.

In summary, resistance exercise is considered safe with few negative reports, making it a promising option for those wanting to improve their health at home. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores a home-based exercise program specifically designed for individuals with diabetes and chronic kidney disease. Unlike standard care, which typically includes general diet and physical activity education, this trial emphasizes resistance training combined with targeted dietary guidance through home video education. This approach not only aims to improve physical strength and overall health but also allows for flexible, at-home participation, which can be more accessible and sustainable for frail and pre-frail participants. The trial seeks to understand how this tailored exercise intervention might better support individuals in managing their conditions compared to traditional methods.

What evidence suggests that this trial's resistance exercise intervention could be effective for diabetes and chronic kidney disease?

This trial will compare resistance exercise interventions with standard care for participants with diabetes and chronic kidney disease. Studies have shown that resistance exercise benefits people with chronic kidney disease (CKD) and diabetes by improving mobility and increasing strength. Research also indicates that this type of exercise helps control blood sugar and blood fats, crucial for managing diabetes and kidney issues. Additionally, resistance exercise can reduce inflammation and enhance heart and lung health in those with CKD. Overall, it may slow disease progression and improve quality of life. ^{1 4 6 7 8}

Who Is on the Research Team?

Diana Mager, PhD MSc RD

Principal Investigator

University of Alberta

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Resistance Exercise

Trial Overview 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.

How Is the Trial Designed?

Group I: Exercise Intervention Pre-Frail Experimental Treatment 1 Intervention

Resistance Exercise Intervention (home video education: resistance training and diet education) for Pre-Frail participants

Group II: Exercise Intervention Frail Experimental Treatment 1 Intervention

Resistance Exercise Intervention (home video education: resistance training and diet education) for Frail participants

Group III: Standard of Care or Control Frail Active Control 1 Intervention

Standard of Care (standard diet and physical activity education) for Frail Participants

Group IV: Standard of Care or Control Pre-Frail Active Control 1 Intervention

Standard of Care (standard diet and physical activity education) for Pre-Frail Participants

Who Is Running the Clinical Trial?

University of Alberta

Lead Sponsor

Trials

957

Recruited

437,000+

Published Research Related to This Trial

Resistance exercise (RE) during hemodialysis significantly improved muscle strength and glucose levels in patients with chronic kidney disease (CKD) and diabetes mellitus (DM) over an eight-week period, indicating its efficacy as a treatment.

Patients participating in RE reported substantial enhancements in quality of life, including better functional capacity, reduced pain, and improved emotional and social well-being, highlighting the positive impact of exercise on overall health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Effect of resistance exercise intradialytic in renal patients chronic in hemodialysis]. Ribeiro, R., Coutinho, GL., Iuras, A., et al.[2019]

Resistance training (RT) has been shown to significantly improve muscle strength and quality of life in chronic kidney patients undergoing hemodialysis, based on a review of 21 studies.

All studies reviewed reported positive outcomes related to biochemical parameters, physical capacity, and body composition, highlighting the potential benefits of incorporating RT into the care of hemodialysis patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Resistance training in hemodialysis patients: a review. Bessa, B., de Oliveira Leal, V., Moraes, C., et al.[2015]

A 10-week supervised resistance exercise program significantly improved health-related quality of life and physical performance in 16 kidney transplant recipients, with notable enhancements in specific quality of life domains and physical tests like the 6-minute walk distance and handgrip strength.

The exercise intervention was safe, with no reported adverse events or injuries, indicating that resistance training can be a beneficial and safe rehabilitation strategy for kidney transplant patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of a resistance training program in kidney transplant recipients: A randomized controlled trial. Hernández Sánchez, S., Carrero, JJ., Morales, JS., et al.[2021]

Resistance or strength exercise training can significantly improve muscle mass, strength, and function in patients with chronic renal failure, potentially reversing malnutrition and delaying disease progression.

Even with low dietary protein intake, resistance training enhances protein metabolism and overall physical function, suggesting it could be a valuable, noninvasive treatment option for improving the quality of life in renal patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Potential benefits of resistance exercise training on nutritional status in renal failure. Castaneda, C., Grossi, L., Dwyer, J.[2019]

Aerobic exercise interventions have been shown to improve physical functioning and performance in patients with chronic kidney disease (CKD), with evidence suggesting benefits for blood pressure control, lipid profiles, and mental health.

Despite the known safety and benefits of exercise for CKD patients, many remain inactive, highlighting the need for better assessment and encouragement of physical activity, particularly through low-intensity resistance and aerobic training programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise and chronic kidney disease: current recommendations. Johansen, KL.[2022]

Home-based exercise programs significantly improve fitness levels and quality of life for individuals with chronic kidney disease, based on a systematic review of 14 studies, 11 of which were included in the meta-analysis.

While home exercise is generally safe and feasible, adherence rates were low, indicating that many participants dropped out, suggesting a need for strategies to improve retention in future studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Home-Based Exercise for People With Chronic Kidney Disease: A Systematic Review and Meta-Analysis. Pedroso, RV., Sanchez-Lastra, MA., Comesaña, LI., et al.[2022]

A 6-month home-based exercise program significantly improved physical functioning in patients with Stage 4 chronic kidney disease (CKD), as evidenced by a greater increase in the incremental shuttle walking test compared to a control group.

The exercise program also enhanced health-related quality of life (HRQOL) in several domains, including work status and social interaction, while showing potential benefits on kidney function and related biomarkers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Home-based aerobic exercise and resistance training for severe chronic kidney disease: a randomized controlled trial. Uchiyama, K., Adachi, K., Muraoka, K., et al.[2022]

Recent evidence supports the use of exercise-based rehabilitation for individuals with chronic kidney disease (CKD), highlighting its potential to improve health-related quality of life and overall outcomes.

There is a growing commitment within the kidney research community to implement practical exercise interventions, including options for prehabilitation and post-transplant rehabilitation, as well as tailored programs for those undergoing hemodialysis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise as a therapeutic intervention in chronic kidney disease: are we nearly there yet? Castle, EM., Billany, RE., Lightfoot, CJ., et al.[2023]

Aerobic exercise and resistance training can significantly improve health outcomes in chronic kidney disease (CKD) patients by reducing inflammation, increasing insulin sensitivity, and potentially enhancing kidney function, as evidenced by improvements in glomerular filtration rate (GFR) and reductions in microalbuminuria.

Combining both aerobic and resistance training during dialysis has been shown to enhance muscle strength, physical functionality, and overall quality of life, suggesting that exercise could be a vital component in the management and prevention of CKD progression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A comparison of aerobic exercise and resistance training in patients with and without chronic kidney disease. Moinuddin, I., Leehey, DJ.[2022]

Exercise training has been shown to significantly improve physical function, fitness, and quality of life in individuals with chronic kidney disease, yet it is not commonly included in standard kidney care programs.

To integrate exercise rehabilitation into kidney care, it is essential to focus on clinically relevant outcomes for patients, implement evidence-based strategies, and treat exercise as a legitimate medical therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Advancing Exercise Science for Better Health Outcomes Across the Spectrum of Chronic Kidney Disease. Bohm, C., Bennett, P., Lambert, K., et al.[2023]

A 12-week lifestyle intervention involving exercise and dietary changes in 9 obese patients with chronic kidney disease (CKD) led to significant weight loss and improved exercise capacity, indicating that such interventions are feasible and beneficial for this population.

The intervention also resulted in enhanced insulin sensitivity and favorable changes in adipokines, although kidney function remained unchanged, suggesting that while lifestyle modifications can improve metabolic health, their long-term impact on kidney function needs further study.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Trial of Lifestyle Modification on Cardiopulmonary, Inflammatory, and Metabolic Effects among Obese with Chronic Kidney Disease. Navaneethan, SD., Fealy, CE., Scelsi, AC., et al.[2018]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10967118/

Impact of resistance exercise on patients with chronic ... Resistance exercise can improve physical function, metabolic condition, inflammatory response and cardiopulmonary function in CKD patients.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11743718/

The impact of different exercise modalities on chronic kidney ... This study sought to summarize the effects of different exercise modalities on the main outcomes impacted by CKD.

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. nature.com nature.com/articles/s41598-024-53333-4

The effect of periodic resistance training on obese patients ... Deus et al. also pointed out that, Resistance training can effectively control glucose and blood lipid in kidney disease. Resistance training- ...

5. rrtjournal.biomedcentral.com rrtjournal.biomedcentral.com/articles/10.1186/s41100-025-00658-z

Effectiveness of exercise therapy in managing muscle atrophy ... Resistance training showed the greatest effect on strength outcomes, particularly in dialysis patients, while combined aerobic and ...

6. 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 ...

7. ahajournals.org ahajournals.org/doi/10.1161/CIR.0000000000001189

Resistance Exercise Training in Individuals With and ... Resistance training is a safe and effective approach for improving cardiovascular health in adults with and without cardiovascular disease.

8. frontiersin.org frontiersin.org/journals/physiology/articles/10.3389/fphys.2024.1444976/full

The impact of different exercise modalities on chronic ... We found 7 (6.2%) significant reports for home-based training. There were 6 (5.3%) significant reports for isometric training, 10 (8.8%) for resistance training ...