Pilot - Resistance Exercise for Inpatient Treatment in T2D

NCT06547541 | Terminated Phase 1 DMC

• 2 other identifiers: H-24002354PREFIT-T2D
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 2

Brief Summary

Type 2 Diabetes (T2D) is associated with prolonged hospitalization and an increased risk of readmission. Moreover, sedentary behavior and poor glycemic control may contribute to disease severity and mortality. The inactivity during hospitalization is particularly concerning in T2D patients, due to the negative effect on glucose metabolism and secondary loss of skeletal muscle mass, which can further disrupt glucose regulation. However, there are no exercise guidelines for hospitalized T2D patients. To address this gap, a feasibility study will be conducted examining the effectiveness of incorporating resistance training into hospital care for T2D patients. For the feasibility study, 24 patients with T2D or prediabetes will be recruited from the Department of Infectious Diseases at Rigshospitalet and Hvidovre Hospital and randomized to 4 weeks of resistance training for 30 minutes per day or standard treatment. If the participants are discharged they will be offered online-training sessions. During the hospitalization a continuous glucose monitor will be applied and an accelerometer during the full intervention. At baseline, discharge and at follow-up, extensive testing will be performed.

Conditions

Diabetes Mellitus, Type 2; Prediabetes or Diabetes; Prediabetes

Keywords

Exercise; Glycemic control

Outcome Measures

Primary Outcomes (2)

• Feasibility of exercise in hospitalized patients with type 2 diabetes

  • Recruitment: Include 24 patients in five months. Failure to achieve this goal will indicate challenges in the recruitment process. The recruitment will be continuously evaluated. o Failure to recruit 5 participants within the 1st month of recruitment will lead to patients with prediabetes (HbA1c ≥ 42 mmol/mol) being eligible for inclusion. This criterion will be assessed monthly and if the projected recruitment of 4-5 patients/month is not met, the inclusion criteria will be expanded to include prediabetes. If so, an amendment will be submitted to change the title of the project to include prediabetes. An intermediate state of diabetes also has a higher frequency of critical outcomes during hospitalization, and is inversely related to skeletal muscle mass.

  Baseline to follow-up visit (4 weeks).

• Glycemic variability

  Coefficient of variance (%CV) during hospitalization evaluated using a continuous glucose monitor. Defined as the oscillations in blood glucose occurring throughout the day. High glycemic variability is associated with an increased risk of cardiovascular events, mortality, and impaired quality of life. Glycemic variability adds considerable nuance to blood glucose control and allows for short-term assessments compared to glycated hemoglobin. If the participant is not discharged after 4 weeks the data collection will stop.

  Baseline until discharge, with a maximum of 4 weeks post-inclusion.

Secondary Outcomes (43)

• Short physical performance battery

  Baseline to follow-up visit (4 weeks).

• Sit-down stand-up test

  Baseline to follow-up visit (4 weeks).

• Grip strength

  Baseline to follow-up visit (4 weeks).

• Duration of hospitalization

  Baseline until discharge, with a maximum of 1 year post intervention.

• Insulin use during hospitalization

  Baseline until discharge, with a maximum of 4 weeks post-inclusion.

Study Arms (2)

Exercise

EXPERIMENTAL

The exercise intervention is a four-week intervention and will consist of body weight strength training. All training sessions during hospitalization will be supervised and will be performed individually for 30 min/day. If the patient is discharged within the four-week training period, the training will continue from home and will be online-based with a live video connection to an instructor. The training program will be the same. The intervention group will ideally exercise post-prandially (within 60 min following the meal) following either breakfast or lunch. Exercise intensity will be monitored throughout the training (with a heart rate monitor) and patients will estimate the rigorousness of the training using the rate of perceived exertion (RPE)-scale. If possible, the goal is for the patients to reach a minimum of 5, corresponding to moderate intensity, but preferably 7+ on the 0-10 RPE scale in each set. The aim is to complete the training sessions five out of seven days/week.

Behavioral: Exercise

Control

NO INTERVENTION

The Control group will be placed in a chair for 30 minutes, within 60 minutes following either breakfast or lunch daily during admission, depending on other workflows in the ward. This corresponds to the time spent on exercise by the intervention group. The control group will also be in daily contact with the instructor following discharge and will be asked the same daily questions and will be seated in a chair for 30 minutes as during hospitalization.

Interventions

Exercise BEHAVIORAL

A body weight based resistance training.

Exercise

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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) (from 18 of September, 2024)
• 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"

You may not qualify if:

• 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

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead
• TrygFonden, Denmark: collaborator

Study Sites (2)

Copenhagen University Hospital

Copenhagen, Capitol Region of Denmark, 2100, Denmark

Location

Departement of Infectious Diseases - Hvidovre Hospital

Copenhagen, Capitol Region of Denmark, 2650, Denmark

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Prediabetic State; Diabetes Mellitus; Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Researcher

Study Record Dates

• First Submitted: July 28, 2024
• First Posted: August 9, 2024
• Study Start: August 12, 2024
• Primary Completion: March 19, 2025
• Study Completion: March 20, 2025
• Last Updated: January 21, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

DK (2)