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Home-Based Exercise for Diabetes & Chronic Kidney Disease (Fantastic Trial)

N/A
Recruiting
Led By Diana Mager, PhD MSc RD
Research Sponsored by University of Alberta
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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)
Must not have
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)
Dialysis (hemodialysis or peritoneal dialysis) as treatment of kidney disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up six months
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a lifestyle intervention program focused on optimizing diet and physical activity in adults with diabetes and chronic kidney disease to prevent frailty.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Since the intervention involves dietary changes and resistance exercise, potential side effects may include muscle soreness or strain from new physical activities. Dietary adjustments might also cause temporary digestive discomfort.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 50 and 85 years old.
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I have Type 2 diabetes and my kidney function is reduced but not severely.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I cannot do exercises like walking or standing up from a chair due to severe joint issues.
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I am on dialysis for kidney disease.
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I have severe, permanent vision loss.
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I have had a bone fracture in the past year.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~six months
This trial's timeline: 3 weeks for screening, Varies for treatment, and six months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Changes in frailty status in response to the exercise intervention
Secondary study objectives
Changes in cognitive health
Changes in health related quality of life (HRQOL)
Skeletal muscle structure

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

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 Location

Who is running the clinical trial?

University of AlbertaLead Sponsor
937 Previous Clinical Trials
433,704 Total Patients Enrolled
3 Trials studying Frailty
2,271 Patients Enrolled for Frailty
Diana Mager, PhD MSc RDPrincipal InvestigatorUniversity of Alberta

Media Library

Resistance Exercise Clinical Trial Eligibility Overview. Trial Name: NCT05527574 — N/A
Frailty Research Study Groups: Standard of Care or Control Frail, Standard of Care or Control Pre-Frail, Exercise Intervention Frail, Exercise Intervention Pre-Frail
Frailty Clinical Trial 2023: Resistance Exercise Highlights & Side Effects. Trial Name: NCT05527574 — N/A
Resistance Exercise 2023 Treatment Timeline for Medical Study. Trial Name: NCT05527574 — N/A
~2 spots leftby Dec 2024
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