Physical Rehabilitation of Older Persons Following a Community-Acquired Infection Hospitalization: A Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 460
- 试验地点
- 6
- 主要终点
- Re-hospitalization (infection-related and all-cause)
研究概览
简要总结
Community-acquired infections such as community-acquired pneumonia (CAP) and urinary tract infection (UTI) remain leading causes of hospitalization and death due to infections in older persons in Europe. Hospitalization often results in further disabilities and frailty for older and frail individuals, from which some may never recover. Physical activity is well-established as a cornerstone in the primary prevention and treatment of several noncommunicable diseases. However, there is currently no established rehabilitation model following a pneumonia or other infection, nor is there any evidence to support the impact of rehabilitation on the mental and physical health of older and frail individuals following a pneumonia hospitalization or other infection.
The aim of the feasibility study is to evaluate a patient-centered and individualized exercise intervention that is kick-started during hospitalization and continued for 3 months after discharge with video-supervised home-based exercise training to patients hospitalized with CAP or UTI compared to standard care with regard to safety, clinical outcomes, patients' perception, functional ability, organizational aspects, and economic aspects.
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
- •Patients aged ≥65 years or 18-64 years if the presence of at least one chronic disease (e.g., diabetes, COPD, heart failure, etc.)
- •Suspicious of a lower respiratory tract infection AND
- •Presence of one or more symptoms of a lower respiratory tract infection such as fever ≥38.3°C, hypothermia <35.0°C, new onset of cough, pleuritic chest pain, dyspnea, or altered breath sounds on auscultation.
- •Positive urine nitrate test and/or leukocyturia as depicted by positive esterase test or microscopy AND
- •Presence of one or more symptoms of urinary tract infection such as dysuria, urgent or frequent urination, perineal or suprapubic pain, costo-vertebral tenderness or flank pain, fever (ear or rectal temperature of ≥38.2°C or axillary temperature of ≥38.0°C), or history of feeling feverish with shivering or rigors in the past 24 hours.
- •Functionally independent before hospitalization and expected to be discharged to their own homes.
- •Signed informed consent.
排除标准
- •Hospitalization within the past 14 days.
- •Inability to participate in the study due to dementia, paralysis, or other disorders.
- •Severe aortic valve stenosis or terminal illness.
- •Unstable cardiac arrhythmic disease.
- •High risk for non-adherence as determined by screening evaluation.
- •Already participating in regular exercise training.
- •Unable to understand Danish.
- •Unwilling or unable to give informed consent.
研究组 & 干预措施
Video-supervised home-based exercise training
In-hospital exercise training: 30 min of daily one-on-one supervised exercise training using exercises from the exercise booklet "Sick but Healthy and Active".
Patient-centred video-supervised home-based exercise intervention phase (weeks 0-12): 3 weekly exercise sessions (3 supervised sessions/week) over 12 weeks. Each session will last 45-50 min, consisting of 10-15 min of endurance, 20-30 min of resistance, and 5 min of balance exercises. The exercise intensity will progressively increase during the 12 weeks and be based on a target training intensity of 4-7 points on the Borg CR-10 scale. The exercise training is supplemented with weekly, individualised step-count goals that progressively increase (+5%) if previous step goals are achieved.
Self-directed maintenance exercise phase (weeks 13-24): unsupervised self-directed exercise training 3 times per week for 12 weeks with phone calls, but with less frequency (see standard care below).
干预措施: Video-supervised home-based exercise training (Behavioral)
Standard care
In-hospital: Patients will receive standard of care as recommended by their healthcare personnel.
Control phase (weeks 0-12): Patients are contacted biweekly by phone calls after discharge up to 12 weeks after discharge. The patients will not receive any specific recommendations regarding physical activity.
Control phase (week 13-24): The patients will continuously receive phone calls, but with less frequency (i.e., 3 calls per week in week 13-16, 1 call per week in week 17-20, and 0 call per week in week 21-24).
结局指标
主要结局
Re-hospitalization (infection-related and all-cause)
时间窗: 90 days after discharge.
Report of the total number of re-hospitalized patients, defined as a hospital stay \>12 hours.
次要结局
- Lower limb muscle strength and power(Baseline; 1-month after discharge (secondary endpoint), 3-month after discharge (primary endpoint), and 6-month after discharge (secondary endpoint).)
- Center for Epidemiologic Studies Depression Scale (CES-D)(Baseline; 1-month after discharge (secondary endpoint); 3-month after discharge (primary endpoint); 6-month after discharge (secondary endpoint))
- Physical activity level(Baseline; 1-month after discharge (secondary endpoint); 3-month after discharge (primary endpoint); 6-month after discharge (secondary endpoint))
- Blood sample(Baseline; discharge (secondary endpoint); 1-month after discharge (seconary endpoint), 3-month after discharge (primary endpoint), 6-month after discharge (secondary endpoint), and 12-month after discharge (secondary endpoint).)
- Immune function(Baseline; discharge (secondary endpoint); 1-month after discharge (seconary endpoint), 3-month after discharge (primary endpoint), 6-month after discharge (secondary endpoint), and 12-month after discharge (secondary endpoint).)
- Biobank blood sample(Baseline; discharge (secondary endpoint); 1-month after discharge (seconary endpoint), 3-month after discharge (primary endpoint), 6-month after discharge (secondary endpoint), and 12-month after discharge (secondary endpoint).)
- Insulin resistance(Baseline; 1-month after discharge (secondary endpoint); 3-month after discharge (primary endpoint), and 6-month after discharge (secondary endpoint).)
- Glycemic variability(Baseline (day 0-10); 3-month after discharge (day 80-90, primary endpoint), and 6-month after discharge (day 170-180, secondary endpoint).)
- Semi-structured qualitative interviews(1-month after discharge (seconary endpoint), 3-month after discharge (primary endpoint), and 6-month after discharge (secondary endpoint).)
- Mortality (infection-related and all-cause)(30 days after discharge; 90 days after discharge; 180 days after discharge; 360 days after discharge)
- Adverse events(At 1-month after discharge, 3-month after discharge (primary endpoint), and 6-month after discharge.)
- Blood sample(Baseline; 1-month after discharge (secondary endpoint); 3-month after discharge (primary endpoint); 6-month after discharge (secondary endpoint); and 12-month after discharge (secondary endpoint).)
- Montreal Cognitive Assessment (MoCA)(Baseline; 1-month after discharge (secondary endpoint); 3-month after discharge (primary endpoint); and 6-month after discharge (secondary endpoint).)
- Center for Epidemiologic Studies Depression Scale (CES-D)(Baseline; 1-month after discharge (secondary endpoint); 3-month after discharge (primary endpoint); 6-month after discharge (secondary endpoint))
- Family Reported Outcome Measure (FROM-16)(1-month after discharge (secondary endpoint); 3-month after discharge (primary endpoint); 6-month after discharge (secondary endpoint))
- Physical activity level(Baseline; 1-month after discharge (secondary endpoint); 3-month after discharge (primary endpoint); 6-month after discharge (secondary endpoint))
- Immune function(Baseline; discharge (secondary endpoint); 1-month after discharge (seconary endpoint), 3-month after discharge (primary endpoint), 6-month after discharge (secondary endpoint), and 12-month after discharge (secondary endpoint).)
- Biobank blood sample(Baseline; discharge (secondary endpoint); 1-month after discharge (seconary endpoint), 3-month after discharge (primary endpoint), 6-month after discharge (secondary endpoint), and 12-month after discharge (secondary endpoint).)
- Insulin resistance(Baseline; 1-month after discharge (secondary endpoint); 3-month after discharge (primary endpoint), and 6-month after discharge (secondary endpoint).)
- Glycemic variability(Baseline (day 0-10); 3-month after discharge (day 80-90, primary endpoint), and 6-month after discharge (day 170-180, secondary endpoint).)
- P-glucose during an oral glucose tolerance test (OGTT)(Baseline; 3-month after discharge (primary endpoint), and 6-month after discharge (secondary endpoint).)
- P-insulin during an oral glucose tolerance test (OGTT)(Baseline; 3-month after discharge (primary endpoint), and 6-month after discharge (secondary endpoint).)
- C-peptide during an oral glucose tolerance test (OGTT)(Baseline; 3-month after discharge (primary endpoint), and 6-month after discharge (secondary endpoint).)
- Insulin sensitivity(Baseline; 3 month after discharge (primary endpoint); 6 months after discharge (secondary endpoint).)
- Glucose-lowering medication(Baseline; 3 months after discharge (primary endpoint); 6 months after discharge (secondary endpoint))
- Semi-structured qualitative interviews(1-month after discharge (seconary endpoint), 3-month after discharge (primary endpoint), and 6-month after discharge (secondary endpoint).)
- Adverse events(At 1-month after discharge, 3-month after discharge (primary endpoint), and 6-month after discharge.)
- 30-second sit to stand(Baseline; 1-month after discharge (secondary endpoint); 3-month after discharge (primary endpoint); and 6-month after discharge (secondary endpoint).)
- Barthel index(Baseline; 1-month after discharge (secondary endpoint); 3-month after discharge (primary endpoint); and 6-month after discharge (secondary endpoint).)
- Clinically Frailty Scale(Baseline; 1-month after discharge (secondary endpoint); 3-month after discharge (primary endpoint); and 6-month after discharge (secondary endpoint).)
- EuroQol-5D-5L (EQ-5D-5L)(Baseline; 1-month after discharge (secondary endpoint); 3-month after discharge (primary endpoint); and 6-month after discharge (secondary endpoint).)
- 1-minute sit to stand(Baseline; 1-month after discharge (secondary endpoint); 3-month after discharge (primary endpoint); and 6-month after discharge (secondary endpoint).)
- 6-minute walking test(Baseline; 1-month after discharge (secondary endpoint); 3-month after discharge (primary endpoint); and 6-month after discharge (secondary endpoint).)
- Short Physical Performance Battery (SPPB)(Baseline; 1-month after discharge (secondary endpoint); 3-month after discharge (primary endpoint); and 6-month after discharge (secondary endpoint).)
- 36-Item Short Form Survey (SF-36)(Baseline; 1-month after discharge (secondary endpoint); 3-month after discharge (primary endpoint); and 6-month after discharge (secondary endpoint).)
- COPD Assessment Test (CAT)(Baseline; 1-month after discharge (secondary endpoint); 3-month after discharge (primary endpoint); and 6-month after discharge (secondary endpoint).)
- Re-hospitalization (infection-related and all-cause)(30 days after discharge; 180 days after discharge.)
- Mortality (infection-related and all-cause)(30 days after discharge; 90 days after discharge; 180 days after discharge; 360 days after discharge)
- Handgrip strength(Baseline; 1-month after discharge (secondary endpoint); 3-month after discharge (primary endpoint); and 6-month after discharge (secondary endpoint).)
- Lower limb muscle strength and power(Baseline; 1-month after discharge (secondary endpoint), 3-month after discharge (primary endpoint), and 6-month after discharge (secondary endpoint).)
- Total and appendicular lean and fat mass(Baseline; 1-month after discharge (secondary endpoint); 3-month after discharge (primary endpoint); and 6-month after discharge (secondary endpoint).)
- Muslce quality and density(Baseline; 3-month after discharge (primary endpoint); and 6-month after discharge (secondary endpoint).)
- Fat mass index and fat-free mass index(Baseline; 1-month after discharge (secondary endpoint); 3-month after discharge (primary endpoint); and 6-month after discharge (secondary endpoint).)
- Muscle oxidative stress and inflammation(Baseline; 3-month after discharge (primary endpoint); and 6-month after discharge (secondary endpoint).)
- Muscle protein synthesis and proteolysis(Baseline; 3-month after discharge (primary endpoint); and 6-month after discharge (secondary endpoint).)
- Muscle insulin sensitivity(Baseline; 3-month after discharge (primary endpoint); and 6-month after discharge (secondary endpoint).)
- Skeletal muscle cell growth, development, and function(Baseline; 3-month after discharge (primary endpoint); and 6-month after discharge (secondary endpoint))
- Insulin sensitivity and signaling of adipose tissue(Baseline; 3-month after discharge (primary endpoint); and 6-month after discharge (secondary endpoint))
- Adipose tissue inflammation(Baseline; 3-month after discharge (primary endpoint); and 6-month after discharge (seconary endpoint))
- Adipose tissue immune cell infiltration(Baseline; 3-month after discharg (primary endpoint); and 6-month after discharge (secondary endpoint))
- Pulmonary medication(Baseline; 3 months after discharge (primary endpoint); 6 months after discharge (secondary endpoint))
- Lung function(Baseline, 3 months after discharge (primary endpoint); 6 months after discharge (seconary endpoint))
- Acute exacerbations of COPD(Baseline; 3 months after discharge (primary endpoint); 6 months after discharge (secondary endpoint))
- Health economics(From baseline to 360 days after discharge.)
- Lung function(Baseline; 3 months after discharge (primary endpoint); 6 months after discharge (secondary endpoint))
研究者
Birgitte Lindegaard Madsen
Associate professor, research responsible chief physician, PhD
Nordsjaellands Hospital