Exercise Training as an Intervention to Improve Muscle Function and Recovery Following Bed Rest i… (NCT04057677) | Clinical Trial Compass
TerminatedNot Applicable
Exercise Training as an Intervention to Improve Muscle Function and Recovery Following Bed Rest in Older Adults With Type 2 Diabetes
Stopped: Insufficient funds.
United States12 participantsStarted 2019-12-20
Plain-language summary
The purpose of this research is to gather data on how exercise can help recovery of muscle mass, strength, and physical function after bedrest in older adults with pre-diabetes and type 2 diabetes.
Who can participate
Age range
60 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Participant must be male or female, ages 60 through 80 years of age.
. Participant has pre-diabetes or has been diagnosed with type 2 diabetes and taking 0-3 oral hypoglycemic agents, which include DPP-4 inhibitors, Sulfonylureas and/or Metformin therapy, and has an Hgb A1C \< 8.0%.
. Participants on Insulin, injectable incretin mimetics, SGLT2 inhibitors, and Thiazolidinediones will be excluded.
. Pre-Diabetics are defined as having an HgbA1c of greater than or equal to 5.7% and less 6.5%, or a fasting glucose of greater than or equal to 100 mg/dl and less than 126 mg/dl or has a glucose of greater than or equal to 140 mg/dl and less than 200mg/dl at the 2 hour blood draw during OGTT
. Participant must have renal function with an estimated glomerular filtration rate (eGFR) \> 45 ml/min/1.73m2 determined at screening.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Leg Lean Mass
Timeframe: Immediately following bed rest, and following the exercise or non-exercise recovery phase
2
Mitochondrial Respiration
Timeframe: mmediately following bed rest, and following the exercise or non-exercise recovery phase
Trial details
NCT IDNCT04057677
SponsorAdventHealth Translational Research Institute
. Participant's triglyceride level is \< 350 mg/dl and LDL cholesterol is ≤ 150 mg/dl at screening.
. Participant states willingness to follow protocol as described, the prescribed activity level and completing any forms needed throughout the study.
. Participant has voluntarily signed and dated an informed consent form, approved by an Institutional Review Board/Independent Ethics Committee, and provided Health Insurance Portability and Accountability Act authorization (HIPAA) or other privacy authorization prior to any participation in study.
Exclusion criteria
. Participant has type 1 Diabetes.
. BMI \> 40.0 kg/m2
. Participant is actively pursuing weight loss and/or lifestyle changes.
. Participant has a history of pressure ulcers.
. Participant has a stated history of Deep Vein Thrombosis (DVT), pulmonary embolism, or a known hypercoagulable condition, or other clotting or bleeding disorders.
. History of gastrointestinal or intracranial hemorrhage.
. History of stroke or cerebrovascular accident.
. Recent history of major trauma (within 3 months).