Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06547541
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-28
Brief Title:
Pilot - Resistance Exercise for Inpatient Treatment in T2D
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Exercise Training During Hospitalization in Patients With Type 2 Diabetes - A Phase 1 Trial
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
P-REFIT-T2D
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 will be recruited from the Department of Infectious Diseases at Rigshospitalet 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 interventioncontrol 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
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 interventioncontrol 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None