Hospital-to-Home Rehabilitation Through Exercise and Cognitive Training
ConditionAcute Hospitalization
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65+
SponsorUniversidad Pública de Navarra
About this trial
This research project is structured in two phases: an initial observational phase and a subsequent randomized controlled trial (RCT) phase. The goal of the observational phase is to compare hospital admission and Hospital at Home (HaH). The objective of the RCT is to assess the effectiveness of a multicomponent intervention following acute hospitalization in older adults. The main questions it aims to answer are:
* What are the differences between hospital admission and HaH in sedentary and physical activity levels? * What are the effects of a multicomponent intervention following acute hospitalization in older adults?
Researchers will compare a post-discharge multicomponent intervention to usual care to see the effects on physical and cognitive function.
Participants will receive a home-based cognitive and physical exercise intervention or usual care.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Older adults admitted to the hospital or Hospital at Home (HaH) due to an acute illness.
Residents of Navarre.
Willingness to participate on a voluntary basis.
Ability to ambulate with or without assistance.
Disqualifiers
Acute illness that does not allow the assessment and practice of physical exercise during the study.
Medical contraindication for the practice of physical exercise.
Severe dementia.
Refusal to sign the informed consent form by the patient, accompanying person, or legal guardian.
Trial design
Design model
Parallel
Treatments tested in this trial
Physical exercise and cognitive exercises
BehavioralThe intervention will be based on the Vivifrail program, which is a multicomponent physical exercise program designed specifically for older adults.
Treatment groups
200 Participants
are divided into 2 treatment groupsGroup A: Multicomponent interventionExperimental treatment 1 intervention
Group B: Usual careNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Physical function
Short Physical Performance Battery (SPPB): scores range from 0 to 12, with higher scores indicating better physicalfunction.
Time frame
Within the first 24-48 hours of acute care admission (in hospital or home hospitalization), pre-intervention baseline, and immediately after the intervention.2
Cognitive function
Mini-Mental State Examination (MMSE): scores range from 0 to 30, with higher scores indicating better cognitive function.
Time frame
Within the first 24-48 hours of acute care admission (in hospital or home hospitalization), pre-intervention baseline, and immediately after the intervention.3
Physical activity
Physical activity will be assessed with a Firstbeat device (format: hh:mm:ss).
Time frame
During hospital stay or during home-base hospitalization .4
Sedentarism
Sedentarism will be assessed with a Firstbeat device (format: hh:mm:ss).
Time frame
During hospital stay or during home-based hospitalization.Secondary outcomes
1
Health-related quality of life (HRQOL)
EQ-5D-5L provides a health profile that is converted to a utility index, in which 0 is equivalent to death and 1 indicates perfect health. Additionally, the EQ-VAS ranges from 0 to 100, with higher scores indicating better health.
Time frame
Pre-intervention baseline and immediately after the intervention.2
Heart rate variability
Heart rate variability will be assessed usign a Firstbeat device.
Time frame
During hospital stay or during home-based hospitalization.3
Handgrip strength
Handgrip strength will be measured using a handgrip dynamometer.
Time frame
Within the first 24-48 hours of acute care admission (in hospital or home hospitalization), pre-intervention baseline, and immediately after the intervention.4
Sleep quantity
Sleep duration will be recorded (format: hh:mm:ss).
Time frame
During hospital stay or during home-based hospitalization.Locations
Sponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: