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Exercise Training as an Intervention to Improve Muscle Function and Recovery Following Bed Rest in Older Adults With Type 2 Diabetes | Clinical Trials | Clareo Health

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Exercise Training as an Intervention to Improve Muscle Function and Recovery Following Bed Rest in Older Adults With Type 2 Diabetes

NCT04057677•AdventHealth Translational Research Institute

View on ClinicalTrials.gov

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.

Detailed Description

Older adults with type 2 diabetes (T2D) experience an accelerated rate of sarcopenia, which is the deterioration in muscle mass, strength, and physical performance. Periods of disuse caused by illness or hospitalization causes rapid loss of muscle mass and strength, which negatively impact physical function upon re-ambulation. Without adequate rehabilitation, physical function does not fully recover in older adults following disuse, reducing the quality of life and loss of independence. In this study, participants will enter a 10-day strictly controlled bed rest intervention at the Translational Research Institute (TRI) clinical research unit. Participants are randomized to either a progressive 4-week aerobic and resistance training recovery program at the exercise training or an ambulatory recovery group. The overall objective of this project is to determine how an exercise intervention can aid in recovery of muscle mass, strength and physical function following bed rest in older adults with pre-diabetes and T2D.

Eligibility

Age

60 - 80 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•1. Participant must be male or female, ages 60 through 80 years of age.
•2. 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%.
•1. Participants on Insulin, injectable incretin mimetics, SGLT2 inhibitors, and Thiazolidinediones will be excluded.
•2. 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
•3. Participant must have renal function with an estimated glomerular filtration rate (eGFR) \> 45 ml/min/1.73m2 determined at screening.
•4. Participant's triglyceride level is \< 350 mg/dl and LDL cholesterol is ≤ 150 mg/dl at screening.
•5. Participant states willingness to follow protocol as described, the prescribed activity level and completing any forms needed throughout the study.
•6. 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

•1. Participant has type 1 Diabetes.
•2. BMI \> 40.0 kg/m2
•3. Participant is actively pursuing weight loss and/or lifestyle changes.
•4. Participant has a history of pressure ulcers.
•5. Participant has a stated history of Deep Vein Thrombosis (DVT), pulmonary embolism, or a known hypercoagulable condition, or other clotting or bleeding disorders.
•6. History of gastrointestinal or intracranial hemorrhage.
•7. History of stroke or cerebrovascular accident.
•8. Recent history of major trauma (within 3 months).
•9. Thrombocytopenia (\<100,000/microL) or hyperkalemia (K \> 5.2) on screening laboratory assay. May repeat lab value per PI discretion.
•10. Untreated or poorly controlled hypertension (SBP \> 150, DBP \> 95), or hypotension (SBP \<100 DBP \<60)
+24 more criteria

Locations (1)

AdventHealth Translational Research Institute

Orlando, Florida, United States

Key Dates

Start Date

December 20, 2019

Primary Completion Date

May 1, 2023

Completion Date

February 7, 2025

Last Updated

June 6, 2025

Enrollment

ACTUAL participants

Conditions

Type 2 DiabetesMuscular AtrophySedentary BehaviorExercisePre-diabetes

Interventions

Bed Rest Intervention

BEHAVIORAL

Exercise Program

BEHAVIORAL

Feasibility of a Tailored Online Self-compassion Intervention

NCT07051005

Type 1 Diabetes MellitusType 2 Diabetes Mellitus (T2DM)

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RECRUITINGPHASE2

Trial Against INtractable Type 2 Diabetes (CAPTAIN-T2D)

NCT07296484

Type 2 DiabetesCortisol Excess

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 6, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Exercise Training as an Intervention to Improve Muscle Function and Recovery Following Bed Rest in Older Adults With Type 2 Diabetes

Inclusion Criteria

Exclusion Criteria

Feasibility of a Tailored Online Self-compassion Intervention

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