Resistance exercise program for hospitalized patients with Type 2 Diabetes

Exercise Training During Hospitalization in Patients with Type 2 Diabetes - a Phase 1 Trial

This study is testing if a daily resistance exercise program can help hospitalized patients with Type 2 Diabetes feel better and manage their blood sugar more effectively compared to those who just receive standard care.

Quick facts

• Phase: PHASE1
• Study type: Interventional
• Enrollment: 24 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Rigshospitalet, Denmark (other)
• Locations: 2 sites (Copenhagen, Capitol Region of Denmark and 1 other locations)
• Trial ID: NCT06547541 on ClinicalTrials.gov

What this trial studies

This pilot study aims to evaluate the feasibility and effectiveness of incorporating a resistance exercise program into the care of hospitalized patients with Type 2 Diabetes (T2D) or prediabetes. A total of 24 patients will be recruited from the Department of Infectious Diseases at Rigshospitalet and Hvidovre Hospital, and they will be randomized to either a resistance training group or a control group receiving standard treatment. The intervention consists of 30 minutes of bodyweight resistance exercises daily for four weeks, while the control group will remain seated for the same duration. Various assessments, including glucose monitoring and questionnaires, will be conducted to evaluate the impact of the exercise on glycemic control and overall well-being.

Who should consider this trial

Good fit: Ideal candidates for this study are hospitalized adults aged 18 and older with Type 2 Diabetes or prediabetes who are expected to remain in the hospital for at least three days.

Not a fit: Patients who are terminally ill, have unstable cardiac conditions, or are unable to participate in the exercise program will not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could improve glycemic control and reduce the risk of complications for hospitalized patients with Type 2 Diabetes.

How similar studies have performed: While this specific approach is novel, similar studies have shown that exercise can positively impact glycemic control in diabetic patients.

Eligibility criteria

Inclusion Criteria:

* T2D or prediabetes defined as at least one of the following

  * ICD-10 diagnosis of T2D (DE11.x)
  * HbA1c \> 48 at time of admission
  * Use of type 2 antidiabetic medicine (excluding SGLT2 inhibitors)
  * HbA1c ≥ 42 within 3 months of admission (prediabetes)
* Hospitalized with an infection
* Expected residual hospitalization time of at least three days
* At least 18 years of age
* Able to perform exercises in the booklet "Syg men sun dog aktiv"

Exclusion Criteria:

* Admitted to the hospital more than 5 days ago
* Unable to give written consent to participate
* Terminal illness
* Unstable or new onset angina
* Ventricular arrhythmia
* Aortic stenosis
* Sternotomy in conjunction with the current hospitalization
* Blood pressure greater than 180/120 mmHg
* Kidney failure requiring dialysis
* Unable to follow the 3-stage command of the Mini-Mental State Examination
* Known allergy or contact dermatitis to tape, and CGMs

Where this trial is running

Copenhagen, Capitol Region of Denmark and 1 other locations

• Copenhagen University Hospital — Copenhagen, Capitol Region of Denmark, Denmark (RECRUITING)
• Departement of Infectious Diseases - Hvidovre Hospital — Copenhagen, Capitol Region of Denmark, Denmark (NOT_YET_RECRUITING)

Study contacts

• Study coordinator: Erik Niklasson PhD-student, MD

Conditions: Diabetes Mellitus, Type 2, Prediabetes or Diabetes, Prediabetes, Exercise, Glycemic control