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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Phase 1
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Denmark
Copenhagen University Hospital
RECRUITING
Copenhagen
Departement of Infectious Diseases - Hvidovre Hospital
NOT_YET_RECRUITING
Copenhagen
Contact Information
Primary
Erik Niklasson PhD-student, MD
erik.karl.anders.niklasson@regionh.dk
4550262014
Time Frame
Start Date: 2024-08-12
Estimated Completion Date: 2026-06
Participants
Target number of participants: 24
Treatments
Experimental: Exercise
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.
No_intervention: Control
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.
Related Therapeutic Areas
Sponsors
Collaborators: TrygFonden, Denmark
Leads: Rigshospitalet, Denmark

This content was sourced from clinicaltrials.gov