Exercise Training During Hospitalization in Patients with Type 2 Diabetes - a Phase 1 Trial
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Feasibility of exercise in hospitalized patients with type 2 diabetes
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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"
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Exercise (Behavioral)
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.
结局指标
主要结局
Feasibility of exercise in hospitalized patients with type 2 diabetes
时间窗: 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
时间窗: 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.
次要结局
- Readmission rates.(Baseline until 1 year follow-up.)
- Sick leave rates.(Baseline until 1 year follow-up.)
- Bioelectrical Impedance - Total lean body mass(Baseline to follow-up visit (4 weeks).)
- Insulin use during hospitalization(Baseline until discharge, with a maximum of 4 weeks post-inclusion.)
- Duration of hospitalization(Baseline until discharge, with a maximum of 1 year post intervention.)
- Mean glucose levels(Baseline until discharge, with a maximum of 4 weeks post-inclusion.)
- Time in normal glucose range(Baseline until discharge, with a maximum of 4 weeks post-inclusion.)
- Perceived health - Brief Illness Perception Questionnaire (BIPQ)(Baseline to follow-up visit (4 weeks).)
- Sit-down stand-up test(Baseline to follow-up visit (4 weeks).)
- Mean amplitude of glucose excursions(Baseline until discharge, with a maximum of 4 weeks post-inclusion.)
- Cognitive function(Baseline to follow-up visit (4 weeks).)
- Dual Energy X-Ray Absorptiometry - Appendicular lean mass(Follow-up visit (4 weeks).)
- Dual Energy X-Ray Absorptiometry - Percentage of body fat(Follow-up visit (4 weeks).)
- Rectus femoris echo variation(Baseline to follow-up visit (4 weeks).)
- Bioelectrical Impedance - Appendicular lean body mass(Baseline to follow-up visit (4 weeks).)
- Bioelectrical Impedance - Percentage of body fat(Baseline to follow-up visit (4 weeks).)
- Short physical performance battery(Baseline to follow-up visit (4 weeks).)
- Time in hypoglycemia(Baseline until discharge, with a maximum of 4 weeks post-inclusion.)
- Strength, Assistance in walking, Rise from a chair, Climb stairs, and Falls (SARC-F) questionnaire.(Baseline to follow-up visit (4 weeks).)
- Perceived health - Health-related Quality of Life questionnaire (Euroqol EQ-5D-5L)(Baseline to follow-up visit (4 weeks).)
- Dual Energy X-Ray Absorptiometry- Gynoid fat(Follow-up visit (4 weeks).)
- Rectus femoris cross-sectional area(Baseline to follow-up visit (4 weeks).)
- Grip strength(Baseline to follow-up visit (4 weeks).)
- Time in hyperglycemia(Baseline until discharge, with a maximum of 4 weeks post-inclusion.)
- Dual Energy X-Ray Absorptiometry - Android fat(Follow-up visit (4 weeks).)
- Rectus femoris pennation angle(Baseline to follow-up visit (4 weeks).)
- Rectus femoris echo intensity(Baseline to follow-up visit (4 weeks).)
- Thickness of rectus femoris(Baseline to follow-up visit (4 weeks).)
- Use of antidiabetic medication 1-year post inclusion(Baseline until 1 year follow-up.)
- Circulatory factors in plasma - Interleukin-4(Baseline to follow-up visit (4 weeks).)
- Circulatory factors in plasma - Interleukin-13(Baseline to follow-up visit (4 weeks).)
- Circulatory factors in plasma - Tumor Necrosis Factor-α(Baseline to follow-up visit (4 weeks).)
- Circulatory factors in plasma - Myostatin(Baseline to follow-up visit (4 weeks).)
- Thickness of the anterior thigh muscles(Baseline to follow-up visit (4 weeks).)
- All cause mortality(Baseline until 1 year follow-up.)
- Circulatory factors in plasma - Interferon-γ(Baseline to follow-up visit (4 weeks).)
- Circulatory factors in plasma - Follistatin(Baseline to follow-up visit (4 weeks).)
- Circulatory factors in plasma - Interleukin-1β(Baseline to follow-up visit (4 weeks).)
- Circulatory factors in plasma - Interleukin-2(Baseline to follow-up visit (4 weeks).)
- Circulatory factors in plasma - Interleukin-6(Baseline to follow-up visit (4 weeks).)
- Circulatory factors in plasma - Interleukin-8(Baseline to follow-up visit (4 weeks).)
- Circulatory factors in plasma - Interleukin-10(Baseline to follow-up visit (4 weeks).)
- Circulatory factors in plasma - Interleukin-12p70(Baseline to follow-up visit (4 weeks).)
研究者
Julie Abildgaard
Senior Researcher
Rigshospitalet, Denmark