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

NCT04057677 | Terminated DMC

• 2 other identifiers: 1461891R01AG060153
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Type 2 Diabetes; Muscular Atrophy; Sedentary Behavior; Exercise; Pre-diabetes

Outcome Measures

Primary Outcomes (2)

• Leg Lean Mass

  Determined by DXA (dual energy x-ray absorptiometry)

  Immediately following bed rest, and following the exercise or non-exercise recovery phase

• Mitochondrial Respiration

  Determined by high resolution respirometry in permeabilized muscle fiber bundles

  mmediately following bed rest, and following the exercise or non-exercise recovery phase

Secondary Outcomes (2)

• Insulin Sensitivity

  mmediately following bed rest, and following the exercise or non-exercise recovery phase

• Physical function

  mmediately following bed rest, and following the exercise or non-exercise recovery phase

Study Arms (2)

Exercise Recovery

EXPERIMENTAL

Older males and females with pre-diabetes or type 2 diabetes. We are examining the effects of a recovery exercise program for older adults with pre-diabetes and type 2 diabetes. Following 10 days of bed rest and during the first 4 weeks of recovery, participants will perform a combination of aerobic and resistance exercise training.

Behavioral: Bed Rest Intervention; Behavioral: Exercise Program

Non-Exercise Recovery

EXPERIMENTAL

Older males and females with pre-diabetes or type 2 diabetes. Participants in the ambulatory recovery group will not receive any exercise intervention or advice on exercise following 10 days of bed rest. Rather these participants will return to their regular daily routine that they engaged in prior to the bed rest intervention.

Behavioral: Bed Rest Intervention

Interventions

Bed Rest Intervention BEHAVIORAL

The participant will remain in bed rest for 10 days at the clinical research unit at TRI, AdventHealth, Orlando.

Exercise Recovery; Non-Exercise Recovery

Exercise Program BEHAVIORAL

During the first 4 weeks following bed rest, participants will perform a combination of aerobic and resistance exercise training with a certified exercise physiologist 3 days per week at the TRI exercise training facility.

Exercise Recovery

Eligibility Criteria

• Age: 60 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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).
• Thrombocytopenia (\<100,000/microL) or hyperkalemia (K \> 5.2) on screening laboratory assay. May repeat lab value per PI discretion.
• Untreated or poorly controlled hypertension (SBP \> 150, DBP \> 95), or hypotension (SBP \<100 DBP \<60)
• Participant has hypothyroidism (TSH less than or equal to (0.5mIU/L) or hyperthyroidism TSH greater than or equal to 10mIU/L.
• Participant has current infection (requiring prescription antimicrobial or antiviral medication, or hospitalization), or corticosteroid treatment (with the exception of inhaled or topical steroids) in the last 3 months prior to screening visit.
• Participant is currently taking anti-inflammatory medication or has had anti-inflammatory medication within 1 week prior to screening (including over the counter formulations; e.g. Aleve, Motrin, ibuprofen, naproxen, low dose asprin).
• Participant has had surgery requiring \> 2 days of hospitalization in the last 1 month prior to screening visit.
• Participant has an active malignancy or autoimmune disease.

Sponsors & Collaborators

• AdventHealth Translational Research Institute: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

AdventHealth Translational Research Institute

Orlando, Florida, 32804, United States

Location

Related Links

• AdventHealth Translational Research Institute

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Muscular Atrophy; Sedentary Behavior; Motor Activity; Glucose Intolerance

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Behavior; Hyperglycemia

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Paul Coen, PhD

  Principal Investigator

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The proposed clinical study is a prospective, parallel two arm, randomized controlled trial

Study Record Dates

• First Submitted: August 6, 2019
• First Posted: August 15, 2019
• Study Start: December 20, 2019
• Primary Completion: May 1, 2023
• Study Completion: February 7, 2025
• Last Updated: June 6, 2025

Record last verified: 2025-06

Locations

US (1)