Diabetes Mellitus, Type 2Phase 1P-REFIT-T2DNCT06547541
Pilot - Resistance Exercise for Inpatient Treatment in T2D
A Phase 1 study testing Exercise in people with Diabetes Mellitus, Type 2 and Prediabetes or Diabetes, run by Copenhagen University Hospital, Rigshospitalet at 2 sites in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 2, Prediabetes or Diabetes, Prediabetes
- What is being tested?
- Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 2 sitesDenmark
- Study dates
- 12 Aug 2024to 20 Mar 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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"
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
Denmark2 sites
Copenhagen University Hospital
Copenhagen, Capitol Region of Denmark, 2100
Departement of Infectious Diseases - Hvidovre Hospital
Copenhagen, Capitol Region of Denmark, 2650
About this study
Official title: Exercise Training During Hospitalization in Patients With Type 2 Diabetes - A Phase 1 Trial
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.
Read the 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.
- Being tested
- Exercise
- Keywords
- Exercise, Glycemic control
- Medical subject headings
- Diabetes Mellitus, Type 2, Prediabetic State, Diabetes Mellitus, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseBehavioural
A body weight based resistance training.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
- 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.
Measured: 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.
Measured: Baseline until discharge, with a maximum of 4 weeks post-inclusion.
Secondary outcomes (43)
Short physical performance battery
The Short Physical performance battery (SPPB) will be assessed at baseline, discharge and 30-day follow-up. The SPPB consists of a combined score of a balance test (with the feet together, in a semitandem and tandem position), a walking test measuring the average speed over a three-meter distance, and a chair raise test that evaluates the time it takes for the participant to stand up and sit down five times.
Measured: Baseline to follow-up visit (4 weeks).
Sit-down stand-up test
A sit down stand-up test will be performed at baseline, discharge and 30-day follow-up to assess the number of times the participant can stand up and sit down from a chair within 60 seconds.
Measured: Baseline to follow-up visit (4 weeks).
Grip strength
Grip strength will be assessed at baseline, discharge and 30-day follow-up. Measurements will be taken three times per hand, with the participant in a seated position. The upper arm will be parallel to the torso, the elbow flexed at 90 degrees, and the wrist in a neutral position.
Measured: Baseline to follow-up visit (4 weeks).
Duration of hospitalization
Number of days in hospital, from baseline until a maximum of 1 year post intervention.
Measured: Baseline until discharge, with a maximum of 1 year post intervention.
Insulin use during hospitalization
Number of daily units during hospitalization, from baseline until a maximum of 4 weeks.
Measured: Baseline until discharge, with a maximum of 4 weeks post-inclusion.
Mean glucose levels
Mean glucose levels during hospitalization assessed using a continuous glucose monitor.
If the participant is not discharged after 4 weeks the data collection will stop.
Measured: Baseline until discharge, with a maximum of 4 weeks post-inclusion.
Time in hyperglycemia
Time in hyperglycemia (blood glucose > 10 mmol/l) during hospitalization assessed using a continuous glucose monitor.
If the participant is not discharged after 4 weeks the data collection will stop.
Measured: Baseline until discharge, with a maximum of 4 weeks post-inclusion.
Time in hypoglycemia
Time in hypoglycemia (blood glucose < 4 mmol/l) during hospitalization assessed using a continuous glucose monitor.
If the participant is not discharged after 4 weeks the data collection will stop.
Measured: Baseline until discharge, with a maximum of 4 weeks post-inclusion.
Time in normal glucose range
Time in normal range (6-10 mmol/l in accordance with Danish guidelines), during hospitalization assessed using a continuous glucose monitor.
If the participant is not discharged after 4 weeks the data collection will stop.
Measured: Baseline until discharge, with a maximum of 4 weeks post-inclusion.
Mean amplitude of glucose excursions
Mean amplitude of glucose excursions from peaks to nadirs that are > 1 SD of mean glucose, assessed during hospitalization assessed using a continuous glucose monitor. If the participant is not discharged after 4 weeks the data collection will stop.
Measured: Baseline until discharge, with a maximum of 4 weeks post-inclusion.
Cognitive function
Assessed using the Mini-mental state examination at baseline, discharge and follow-up visit. If the participant is not discharged after 4 weeks the follow-up will be examined at the hospital.
Measured: Baseline to follow-up visit (4 weeks).
Strength, Assistance in walking, Rise from a chair, Climb stairs, and Falls (SARC-F) questionnaire.
Assessed at baseline, discharge and follow-up visit using the questionnaire Strength, Assistance in walking, Rise from a chair, Climb stairs, and Falls (SARC-F).
Measured: Baseline to follow-up visit (4 weeks).
Perceived health - Health-related Quality of Life questionnaire (Euroqol EQ-5D-5L)
Assessed at baseline, discharge and follow-up visit using the questionnaire Health-related Quality of Life questionnaire (Euroqol EQ-5D-5L).
Measured: Baseline to follow-up visit (4 weeks).
Perceived health - Brief Illness Perception Questionnaire (BIPQ)
Assessed at baseline, discharge and follow-up visit using the questionnaire Brief Illness Perception Questionnaire (BIPQ).
Measured: Baseline to follow-up visit (4 weeks).
Dual Energy X-Ray Absorptiometry - Appendicular lean mass
Difference between exercise and control group in appendicular lean mass assessed at the 4-week follow-up using dual energy x-ray absorptiometry.
Measured: Follow-up visit (4 weeks).
Dual Energy X-Ray Absorptiometry - Percentage of body fat
Difference between exercise and control group in percentage of body fat assessed at the 4-week follow-up using dual energy x-ray absorptiometry.
Measured: Follow-up visit (4 weeks).
Dual Energy X-Ray Absorptiometry - Android fat
Difference between exercise and control group in android fat assessed at the 4-week follow-up using dual energy x-ray absorptiometry.
Measured: Follow-up visit (4 weeks).
Dual Energy X-Ray Absorptiometry- Gynoid fat
Difference between exercise and control group in gynoid fat assessed at the 4-week follow-up using dual energy x-ray absorptiometry.
Measured: Follow-up visit (4 weeks).
Rectus femoris cross-sectional area
Change in cross-sectional area assessed at baseline, discharge and 4-week follow-up using an ultrasound of rectus femoris in the dominant leg. If the participant is not discharged after 4 weeks, only baseline and follow-up will be assessed. It will be measured at the distal third and midpoint between the anterior superior iliac spine and the proximal point of the patella.
Measured: Baseline to follow-up visit (4 weeks).
Rectus femoris echo intensity
Change in echo intensity of rectus femoris assessed at baseline, discharge and 4-week follow-up using skeletal muscle ultrasound in the dominant leg. If the participant is not discharged after 4 weeks, only baseline and follow-up will be assessed. It will be measured at the distal third and midpoint between the anterior superior iliac spine and the proximal point of the patella.
Measured: Baseline to follow-up visit (4 weeks).
Rectus femoris echo variation
Change in echo variation of rectus femoris assessed at baseline, discharge and 4-week follow-up using skeletal muscle ultrasound in the dominant leg. If the participant is not discharged after 4 weeks, only baseline and follow-up will be assessed. It will be measured at the distal third and midpoint between the anterior superior iliac spine and the proximal point of the patella.
Measured: Baseline to follow-up visit (4 weeks).
Rectus femoris pennation angle
Change in pennation angle of rectus femoris assessed at baseline, discharge and 4-week follow-up using skeletal muscle ultrasound in the dominant leg. If the participant is not discharged after 4 weeks, only baseline and follow-up will be assessed. It will be measured at the distal third and midpoint between the anterior superior iliac spine and the proximal point of the patella.
Measured: Baseline to follow-up visit (4 weeks).
Thickness of the anterior thigh muscles
Change in anterior thigh muscle thickness assessed at baseline, discharge and 4-week follow-up, measured from the mid-anterior point rectus femoris to the mid posterior point of vastus intermedius of the femoral quadriceps in the dominant leg. If the participant is not discharged after 4 weeks, only baseline and follow-up will be assessed. It will be measured at the distal third and midpoint between the anterior superior iliac spine and the proximal point of the patella.
Measured: Baseline to follow-up visit (4 weeks).
Thickness of rectus femoris
Change in rectus femoris muscle thickness assessed at baseline, discharge and 4-week follow-up, measured from the mid-anterior point rectus femoris to the mid posterior point in the dominant leg. If the participant is not discharged after 4 weeks, only baseline and follow-up will be assessed. It will be measured at the distal third and midpoint between the anterior superior iliac spine and the proximal point of the patella.
Measured: Baseline to follow-up visit (4 weeks).
Bioelectrical Impedance - Appendicular lean body mass
Change in estimated appendicular lean body mass using bioelectrical impedance assessed at baseline, discharge and 4-week follow-up. If the participant is not discharged after 4 weeks, only baseline and follow-up will be assessed.
Measured: Baseline to follow-up visit (4 weeks).
Bioelectrical Impedance - Total lean body mass
Change in estimated total lean body mass using bioelectrical impedance assessed at baseline, discharge and 4-week follow-up. If the participant is not discharged after 4 weeks, only baseline and follow-up will be assessed.
Measured: Baseline to follow-up visit (4 weeks).
Bioelectrical Impedance - Percentage of body fat
Change in estimated percentage of body fat using bioelectrical impedance assessed at baseline, discharge and 4-week follow-up. If the participant is not discharged after 4 weeks, only baseline and follow-up will be assessed.
Measured: Baseline to follow-up visit (4 weeks).
Readmission rates.
Time-to-event, number of events and number of days and reason for event will be assessed. The event will be assessed at 30 days post-discharge, 90 days post-discharge, and 1 year post intervention.
Measured: Baseline until 1 year follow-up.
Sick leave rates.
Time-to-event, number of events and number of days and reason for event will be assessed. The event will be assessed at 30 days post-discharge, 90 days post-discharge, and 1 year post intervention
Measured: Baseline until 1 year follow-up.
All cause mortality
Time-to-event, number of events and number of days and reason for event will be assessed. The event will be assessed during hospitalization, 30 days post-discharge, 90 days post-discharge, and 1 year post intervention.
Measured: Baseline until 1 year follow-up.
Use of antidiabetic medication 1-year post inclusion
The use of which types of antidiabetic medication will be assessed at baseline, discharge, and 1-year follow up.
Measured: Baseline until 1 year follow-up.
Circulatory factors in plasma - Interferon-γ
Change in plasma Interferon-γ assessed using the Meso Scale Discovery's V-PLEX Proinflammatory Panel 1 Human Kit. These samples will be conducted at baseline, discharge, and follow-up visit. If the participant is not discharged within 4 weeks, samples will only be collected at baseline and follow-up.
Measured: Baseline to follow-up visit (4 weeks).
Circulatory factors in plasma - Interleukin-1β
Change in plasma interleukin-1β assessed using the Meso Scale Discovery's V-PLEX Proinflammatory Panel 1 Human Kit. These samples will be conducted at baseline, discharge, and follow-up visit. If the participant is not discharged within 4 weeks, samples will only be collected at baseline and follow-up.
Measured: Baseline to follow-up visit (4 weeks).
Circulatory factors in plasma - Interleukin-2
Change in plasma interleukin-2 assessed using the Meso Scale Discovery's V-PLEX Proinflammatory Panel 1 Human Kit. These samples will be conducted at baseline, discharge, and follow-up visit. If the participant is not discharged within 4 weeks, samples will only be collected at baseline and follow-up.
Measured: Baseline to follow-up visit (4 weeks).
Circulatory factors in plasma - Interleukin-4
Change in plasma interleukin-4 assessed using the Meso Scale Discovery's V-PLEX Proinflammatory Panel 1 Human Kit. These samples will be conducted at baseline, discharge, and follow-up visit. If the participant is not discharged within 4 weeks, samples will only be collected at baseline and follow-up.
Measured: Baseline to follow-up visit (4 weeks).
Circulatory factors in plasma - Interleukin-6
Change in plasma interleukin-6 assessed using the Meso Scale Discovery's V-PLEX Proinflammatory Panel 1 Human Kit. These samples will be conducted at baseline, discharge, and follow-up visit. If the participant is not discharged within 4 weeks, samples will only be collected at baseline and follow-up.
Measured: Baseline to follow-up visit (4 weeks).
Circulatory factors in plasma - Interleukin-8
Change in plasma interleukin-8 assessed using the Meso Scale Discovery's V-PLEX Proinflammatory Panel 1 Human Kit. These samples will be conducted at baseline, discharge, and follow-up visit. If the participant is not discharged within 4 weeks, samples will only be collected at baseline and follow-up.
Measured: Baseline to follow-up visit (4 weeks).
Circulatory factors in plasma - Interleukin-10
Change in plasma interleukin-8 assessed using the Meso Scale Discovery's V-PLEX Proinflammatory Panel 1 Human Kit. These samples will be conducted at baseline, discharge, and follow-up visit. If the participant is not discharged within 4 weeks, samples will only be collected at baseline and follow-up.
Measured: Baseline to follow-up visit (4 weeks).
Circulatory factors in plasma - Interleukin-12p70
Change in plasma interleukin-12p70 assessed using the Meso Scale Discovery's V-PLEX Proinflammatory Panel 1 Human Kit. These samples will be conducted at baseline, discharge, and follow-up visit. If the participant is not discharged within 4 weeks, samples will only be collected at baseline and follow-up.
Measured: Baseline to follow-up visit (4 weeks).
Circulatory factors in plasma - Interleukin-13
Change in plasma interleukin-13 assessed using the Meso Scale Discovery's V-PLEX Proinflammatory Panel 1 Human Kit. These samples will be conducted at baseline, discharge, and follow-up visit. If the participant is not discharged within 4 weeks, samples will only be collected at baseline and follow-up.
Measured: Baseline to follow-up visit (4 weeks).
Circulatory factors in plasma - Tumor Necrosis Factor-α
Change in plasma tumor necrosis factor-α assessed using the Meso Scale Discovery's V-PLEX Proinflammatory Panel 1 Human Kit. These samples will be conducted at baseline, discharge, and follow-up visit. If the participant is not discharged within 4 weeks, samples will only be collected at baseline and follow-up.
Measured: Baseline to follow-up visit (4 weeks).
Circulatory factors in plasma - Myostatin
Change in plasma myostatin assessed using a Meso Scale custom plate. These samples will be conducted at baseline, discharge, and follow-up visit. If the participant is not discharged within 4 weeks, samples will only be collected at baseline and follow-up.
Measured: Baseline to follow-up visit (4 weeks).
Circulatory factors in plasma - Follistatin
Change in plasma follistatin assessed using a Meso Scale custom plate. These samples will be conducted at baseline, discharge, and follow-up visit. If the participant is not discharged within 4 weeks, samples will only be collected at baseline and follow-up.
Measured: Baseline to follow-up visit (4 weeks).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2024
- Study start12 Aug 2024
- Primary completion19 Mar 2025
- Study completion20 Mar 2025
Why it stopped: Too low recruitment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Collaborators
- TrygFonden, Denmark
- Responsible party
- Principal investigator, Julie Abildgaard, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06547541
- Sponsor's protocol ID
- H-24002354
- Other IDs
- PREFIT-T2D
- Acronym
- P-REFIT-T2D
- Status last verified
- Jan 2026
- First submitted
- 28 Jul 2024
- Last updated
- 21 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: If the data can be fully anonymized the researchers will consider to share the data
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exercise Training During Hospitalization in Patients With Type 2 Diabetes - A Phase 1 Trial
- ClinicalTrials.gov ID
- NCT06547541
- Acronym / sponsor ID
- P-REFIT-T2D / H-24002354
- Keywords
- Exercise, Glycemic control
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Too low recruitment.
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Collaborators
- TrygFonden, Denmark
- Study start
- 12 Aug 2024 (actual)
- Primary completion
- 19 Mar 2025 (actual)
- Study completion
- 20 Mar 2025 (actual)
- First posted
- 9 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise | Experimental | Behavioral: ExerciseThe 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- T2D or prediabetes defined as at least one of the following
- 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"
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExerciseA body weight based resistance training. | Behavioural | Exercise |
Primary outcome
Feasibility of exercise in hospitalized patients with type 2 diabetes
Time frame: Baseline to follow-up visit (4 weeks).
• 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.
Glycemic variability
Time frame: Baseline until discharge, with a maximum of 4 weeks post-inclusion.
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.
43 secondary outcomes
Short physical performance battery
Time frame: Baseline to follow-up visit (4 weeks).
Sit-down stand-up test
Time frame: Baseline to follow-up visit (4 weeks).
Grip strength
Time frame: Baseline to follow-up visit (4 weeks).
Duration of hospitalization
Time frame: Baseline until discharge, with a maximum of 1 year post intervention.
Insulin use during hospitalization
Time frame: Baseline until discharge, with a maximum of 4 weeks post-inclusion.
Mean glucose levels
Time frame: Baseline until discharge, with a maximum of 4 weeks post-inclusion.
Time in hyperglycemia
Time frame: Baseline until discharge, with a maximum of 4 weeks post-inclusion.
Time in hypoglycemia
Time frame: Baseline until discharge, with a maximum of 4 weeks post-inclusion.
Time in normal glucose range
Time frame: Baseline until discharge, with a maximum of 4 weeks post-inclusion.
Mean amplitude of glucose excursions
Time frame: Baseline until discharge, with a maximum of 4 weeks post-inclusion.
Cognitive function
Time frame: Baseline to follow-up visit (4 weeks).
Strength, Assistance in walking, Rise from a chair, Climb stairs, and Falls (SARC-F) questionnaire.
Time frame: Baseline to follow-up visit (4 weeks).
Perceived health - Health-related Quality of Life questionnaire (Euroqol EQ-5D-5L)
Time frame: Baseline to follow-up visit (4 weeks).
Perceived health - Brief Illness Perception Questionnaire (BIPQ)
Time frame: Baseline to follow-up visit (4 weeks).
Dual Energy X-Ray Absorptiometry - Appendicular lean mass
Time frame: Follow-up visit (4 weeks).
Dual Energy X-Ray Absorptiometry - Percentage of body fat
Time frame: Follow-up visit (4 weeks).
Dual Energy X-Ray Absorptiometry - Android fat
Time frame: Follow-up visit (4 weeks).
Dual Energy X-Ray Absorptiometry- Gynoid fat
Time frame: Follow-up visit (4 weeks).
Rectus femoris cross-sectional area
Time frame: Baseline to follow-up visit (4 weeks).
Rectus femoris echo intensity
Time frame: Baseline to follow-up visit (4 weeks).
Rectus femoris echo variation
Time frame: Baseline to follow-up visit (4 weeks).
Rectus femoris pennation angle
Time frame: Baseline to follow-up visit (4 weeks).
Thickness of the anterior thigh muscles
Time frame: Baseline to follow-up visit (4 weeks).
Thickness of rectus femoris
Time frame: Baseline to follow-up visit (4 weeks).
Bioelectrical Impedance - Appendicular lean body mass
Time frame: Baseline to follow-up visit (4 weeks).
Bioelectrical Impedance - Total lean body mass
Time frame: Baseline to follow-up visit (4 weeks).
Bioelectrical Impedance - Percentage of body fat
Time frame: Baseline to follow-up visit (4 weeks).
Readmission rates.
Time frame: Baseline until 1 year follow-up.
Sick leave rates.
Time frame: Baseline until 1 year follow-up.
All cause mortality
Time frame: Baseline until 1 year follow-up.
Use of antidiabetic medication 1-year post inclusion
Time frame: Baseline until 1 year follow-up.
Circulatory factors in plasma - Interferon-γ
Time frame: Baseline to follow-up visit (4 weeks).
Circulatory factors in plasma - Interleukin-1β
Time frame: Baseline to follow-up visit (4 weeks).
Circulatory factors in plasma - Interleukin-2
Time frame: Baseline to follow-up visit (4 weeks).
Circulatory factors in plasma - Interleukin-4
Time frame: Baseline to follow-up visit (4 weeks).
Circulatory factors in plasma - Interleukin-6
Time frame: Baseline to follow-up visit (4 weeks).
Circulatory factors in plasma - Interleukin-8
Time frame: Baseline to follow-up visit (4 weeks).
Circulatory factors in plasma - Interleukin-10
Time frame: Baseline to follow-up visit (4 weeks).
Circulatory factors in plasma - Interleukin-12p70
Time frame: Baseline to follow-up visit (4 weeks).
Circulatory factors in plasma - Interleukin-13
Time frame: Baseline to follow-up visit (4 weeks).
Results and safety
The study was stopped early (reason given: Too low recruitment.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2026.
- Individual participant dataSharing planned: No. If the data can be fully anonymized the researchers will consider to share the data
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Exercise in people with Diabetes Mellitus, Type 2 and Prediabetes or Diabetes, run by Copenhagen University Hospital, Rigshospitalet at 2 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 21 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Too low recruitment.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of exercise in hospitalized patients with type 2 diabetes (time frame: Baseline to follow-up visit (4 weeks).). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jan 2026.