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Physical Rehabilitation of Older Persons Following a Community-Acquired Infection Hospitalization: a Feasibility Study (REHAB-CAI)

N

Nordsjaellands Hospital

Status

Begins enrollment in 1 month

Conditions

Urinary Tract Infections
Community-acquired Pneumonia

Treatments

Behavioral: Video-supervised home-based exercise training

Study type

Interventional

Funder types

Other

Identifiers

NCT06689280
H-24047753

Details and patient eligibility

About

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.

Enrollment

50 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Patients aged ≥65 years or ≤65 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.

Exclusion criteria

  • 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

50 participants in 2 patient groups

Video-supervised home-based exercise training
Experimental group
Description:
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-centered video-supervised home-based exercise intervention phase (weeks 0-12): 3 weekly exercise sessions (2 supervised and 1 unsupervised session/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 progressivly 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 individualized 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).
Treatment:
Behavioral: Video-supervised home-based exercise training
Standard care
No Intervention group
Description:
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., 2 calls per week in week 13-16, 1 call per week in week 17-20, and 0 call per week in week 21-24).

Trial contacts and locations

3

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Central trial contact

Birgitte Lindegaard, MD, PhD; Camilla Koch Ryrsø, MSc, PhD

Data sourced from clinicaltrials.gov

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