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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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up six months
Awards & highlights
Fantastic Trial 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.Check my eligibility
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.See study design
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.
Fantastic Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 50 and 85 years old.
Select...
I have Type 2 diabetes and my kidney function is reduced but not severely.
Fantastic Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ six months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~six months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Changes in frailty status in response to the exercise intervention
Secondary outcome measures
Changes in cognitive health
Changes in health related quality of life (HRQOL)
Skeletal muscle structure
Fantastic 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
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Who is running the clinical trial?
University of AlbertaLead Sponsor
889 Previous Clinical Trials
385,014 Total Patients Enrolled
3 Trials studying Frailty
2,271 Patients Enrolled for Frailty
Diana Mager, PhD MSc RDPrincipal InvestigatorUniversity of Alberta
Media Library
Eligibility Criteria:
This trial includes the following eligibility 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 between 50 and 85 years old.I am on dialysis for kidney disease.I have Type 2 diabetes and my kidney function is reduced but not severely.I have severe, permanent vision loss.I have had a bone fracture in the past year.
Research Study Groups:
This trial has the following groups:- Group 1: Standard of Care or Control Frail
- Group 2: Standard of Care or Control Pre-Frail
- Group 3: Exercise Intervention Frail
- Group 4: Exercise Intervention Pre-Frail
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does this research offer the opportunity to participate?
"This research is looking for approximately 120 frail participants aged between 50 and 85. To be considered, these individuals must meet the predetermined criteria."
Answered by AI
Are any new patients able to join this experiment?
"Affirmative. Records hosted on clinicaltrials.gov show that this research is actively looking for participants, which was first published on November 30th 2019 and last modified on September 2nd 2022. To move forward with the trial, a total of 120 individuals must be recruited from only one medical facility."
Answered by AI
Do elderly individuals meeting the age requirement have access to this medical experiment?
"This clinical trial is seeking qualified participants aged between 50 and 85. On the other hand, there are 239 trials available for those below 18 years old and 1623 studies accessible to persons over 65."
Answered by AI
How many participants are being included in this experiment?
"Affirmative. Clinicaltrials.gov conveys that the trial, initially posted on November 30th 2019, is currently recruiting. Approximately 120 participants are needed from 1 location."
Answered by AI
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