Clinical trial NCT06547541: Pilot - Resistance Exercise for Inpatient Treatment in T2D
Official title: Exercise Training During Hospitalization in Patients with Type 2 Diabetes - a Phase 1 Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Diabetes Mellitus, Type 2
Prediabetes or Diabetes
Prediabetes
Keywords: Exercise
Glycemic control
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
Collaborators: name: TrygFonden, Denmark
First posted: 2024-08-09
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: Patients will be invited to participate, preferably within the first 24 hours of admission, and randomized to either resistance-based bodyweight exercise or a control group. In total, 24 patients will be recruited, and distributed between the groups stratified for biological sex. At baseline, participants will have their medical history, social anamnesis, height, and weight assessed. At baseline a continuous glucose monitor will and accelerometer will be applied, to be worn until discharge and end of the intervention, respectively. Furthermore at baseline a multitude of questionnaires will be performed: International Physical Activity Questionnaire (IPAQ), Strength, Assistance in walking, Rise from a chair, Climb stairs, and Falls (SARC-F), Brief Illness Perception Questionnaire (BIPQ), 5-level EQ-5D version (EQ-5D-5L), WHO-5 Well-Being Index (WHO-5).

Intervention session A body-weight based resistance exercise program will be performed based on a booklet "Syg men sund og aktiv" Sick but healthy and active for 30 minutes per day. Described in more detail below.

Control session The control group will be placed in a seated position for 30 minutes corresponding to the time the intervention group is active.

Assessments before and after intervention/control sessions Before the sessions the EQ-5D-5L, the WHO-5 modified to a daily version, and an acute assessment of malaise, tiredness, nausea, dizziness, pain and breathlessness will be performed using numerical rating scales (NRS). After the session the NRS will be performed again.

Follow-up visit Two days after completion of the intervention, the participants will be invited for a follow-up visit at the Centre for Physical Activity Research, Rigshospitalet. This visit includes a qualitative interview, assessment of body composition, assessment of physical capabilities, ultrasound of the thigh, and blood samples. In case the patient is unable to attend the follow-up visit at the center, the daily operating manager will visit the patient at home. In this case, Ultrasound and muscle biopsy will not be performed. If the patient lives more than one hour away by car, the assessment will be performed online and will not include ultrasound, body composition and blood tests.

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

Primary outcomes:
measure: Feasibility of exercise in hospitalized patients with type 2 diabetes
timeFrame: Baseline to follow-up visit (4 weeks).
measure: Glycemic variability
timeFrame: Baseline until discharge, with a maximum of 4 weeks post-inclusion.
Secondary outcomes:
measure: Short physical performance battery
timeFrame: Baseline to follow-up visit (4 weeks).
measure: Sit-down stand-up test
timeFrame: Baseline to follow-up visit (4 weeks).
measure: Grip strength
timeFrame: Baseline to follow-up visit (4 weeks).
measure: Duration of hospitalization
timeFrame: Baseline until discharge, with a maximum of 1 year post intervention.
measure: Insulin use during hospitalization
timeFrame: Baseline until discharge, with a maximum of 4 weeks post-inclusion.
measure: Mean glucose levels
timeFrame: Baseline until discharge, with a maximum of 4 weeks post-inclusion.
measure: Time in hyperglycemia
timeFrame: Baseline until discharge, with a maximum of 4 weeks post-inclusion.
measure: Time in hypoglycemia
timeFrame: Baseline until discharge, with a maximum of 4 weeks post-inclusion.
measure: Time in normal glucose range
timeFrame: Baseline until discharge, with a maximum of 4 weeks post-inclusion.
measure: Mean amplitude of glucose excursions
timeFrame: Baseline until discharge, with a maximum of 4 weeks post-inclusion.
measure: Cognitive function
timeFrame: Baseline to follow-up visit (4 weeks).
measure: Strength, Assistance in walking, Rise from a chair, Climb stairs, and Falls (SARC-F) questionnaire.
timeFrame: Baseline to follow-up visit (4 weeks).
measure: Perceived health - Health-related Quality of Life questionnaire (Euroqol EQ-5D-5L)
timeFrame: Baseline to follow-up visit (4 weeks).
measure: Perceived health - Brief Illness Perception Questionnaire (BIPQ)
timeFrame: Baseline to follow-up visit (4 weeks).
measure: Dual Energy X-Ray Absorptiometry - Appendicular lean mass
timeFrame: Follow-up visit (4 weeks).
measure: Dual Energy X-Ray Absorptiometry - Percentage of body fat
timeFrame: Follow-up visit (4 weeks).
measure: Dual Energy X-Ray Absorptiometry - Android fat
timeFrame: Follow-up visit (4 weeks).
measure: Dual Energy X-Ray Absorptiometry- Gynoid fat
timeFrame: Follow-up visit (4 weeks).
measure: Rectus femoris cross-sectional area
timeFrame: Baseline to follow-up visit (4 weeks).
measure: Rectus femoris echo intensity
timeFrame: Baseline to follow-up visit (4 weeks).
measure: Rectus femoris echo variation
timeFrame: Baseline to follow-up visit (4 weeks).
measure: Rectus femoris pennation angle
timeFrame: Baseline to follow-up visit (4 weeks).
measure: Thickness of the anterior thigh muscles
timeFrame: Baseline to follow-up visit (4 weeks).
measure: Thickness of rectus femoris
timeFrame: Baseline to follow-up visit (4 weeks).
measure: Bioelectrical Impedance - Appendicular lean body mass
timeFrame: Baseline to follow-up visit (4 weeks).
measure: Bioelectrical Impedance - Total lean body mass
timeFrame: Baseline to follow-up visit (4 weeks).
measure: Bioelectrical Impedance - Percentage of body fat
timeFrame: Baseline to follow-up visit (4 weeks).
measure: Readmission rates.
timeFrame: Baseline until 1 year follow-up.
measure: Sick leave rates.
timeFrame: Baseline until 1 year follow-up.
measure: All cause mortality
timeFrame: Baseline until 1 year follow-up.
measure: Use of antidiabetic medication 1-year post inclusion
timeFrame: Baseline until 1 year follow-up.
measure: Circulatory factors in plasma - Interferon-γ
timeFrame: Baseline to follow-up visit (4 weeks).
measure: Circulatory factors in plasma - Interleukin-1β
timeFrame: Baseline to follow-up visit (4 weeks).
measure: Circulatory factors in plasma - Interleukin-2
timeFrame: Baseline to follow-up visit (4 weeks).
measure: Circulatory factors in plasma - Interleukin-4
timeFrame: Baseline to follow-up visit (4 weeks).
measure: Circulatory factors in plasma - Interleukin-6
timeFrame: Baseline to follow-up visit (4 weeks).
measure: Circulatory factors in plasma - Interleukin-8
timeFrame: Baseline to follow-up visit (4 weeks).
measure: Circulatory factors in plasma - Interleukin-10
timeFrame: Baseline to follow-up visit (4 weeks).
measure: Circulatory factors in plasma - Interleukin-12p70
timeFrame: Baseline to follow-up visit (4 weeks).
measure: Circulatory factors in plasma - Interleukin-13
timeFrame: Baseline to follow-up visit (4 weeks).
measure: Circulatory factors in plasma - Tumor Necrosis Factor-α
timeFrame: Baseline to follow-up visit (4 weeks).
measure: Circulatory factors in plasma - Myostatin
timeFrame: Baseline to follow-up visit (4 weeks).
measure: Circulatory factors in plasma - Follistatin
timeFrame: Baseline to follow-up visit (4 weeks).
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Copenhagen University Hospital
state: Capitol Region of Denmark
city: Copenhagen
country: Denmark
facility: Departement of Infectious Diseases - Hvidovre Hospital
state: Capitol Region of Denmark
Study officials:
References: