Home-based lifestyle program to prevent frailty in adults with diabetes and kidney disease
Development of an Innovative Home-based Strategy for FrAilty preveNTion in AdultT With dIabetes and Chronic Kidney Disease (FANTASTIC)
This study is testing a home-based video program to help adults aged 50-85 with Type 2 diabetes and kidney disease improve their diet and activity levels to prevent frailty and boost their overall health.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 50 Years to 85 Years |
| Sex | All |
| Sponsor | University of Alberta Academic / other |
| Locations | 1 site (Edmonton, Alberta) |
| Trial ID | NCT05527574 on ClinicalTrials.gov |
What this trial studies
This study aims to develop and test a home-based video program that focuses on lifestyle modifications, including diet and physical activity, for adults aged 50-85 with Type 2 diabetes and chronic kidney disease. Over a period of six months, participants will receive education and support to improve muscle strength, functionality, and overall health-related quality of life. The research will identify features of frailty and pre-frailty in this population, targeting those who are most vulnerable for intervention. The ultimate goal is to prevent the progression of frailty and reduce healthcare utilization among these individuals.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 50-85 who have been clinically diagnosed with Type 2 diabetes and stage 1-IV chronic kidney disease.
Not a fit: Patients with severe cognitive impairments, recent bone fractures, or those on dialysis will not benefit from this study.
Why it matters
Potential benefit: If successful, this program could significantly improve the quality of life and independence of patients with diabetes and chronic kidney disease by preventing frailty.
How similar studies have performed: Previous studies have shown promise in using lifestyle interventions to improve outcomes in similar populations, indicating that this approach may be effective.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adults (50-85 years) * Clinically Diagnosed with diabetes (Type 2) and stage 1-IV CKD (Glomerular Filtration - Rate (GFR) 10-89 ml/min/1.73m2). Exclusion Criteria: * Functional and cognitive impairments (MMSE scores\<24) * Severe, permanent vision loss. * Recent history of bone fracture in the last 12 months * History of skeletal muscular disorders which precludes the ability to perform resistance exercises (e.g., moderate to severe osteoarthritis that prevents walking, bending and/or sit to stand or wheelchair dependent) * Pregnant women * Dialysis (hemodialysis or peritoneal dialysis) as treatment of kidney disease
Where this trial is running
Edmonton, Alberta
- Diabetic Nephropathy Prevention Clinic - Alberta Kidney Care - North — Edmonton, Alberta, Canada (Recruiting)
Study contacts
- Principal investigator: Diana Mager, PhD MSc RD — University of Alberta
- Study coordinator: Diana Mager, PhD MSc RD
- Email: mager@ualberta.ca
- Phone: 780-492-7687
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.