Clinical trial NCT05424055: Prevention of Functional and Cognitive Impairment in Hospitalized Oncogeriatric Patients
Official title: Prevention of Functional and Cognitive Impairment Through a Multicomponent Exercise Program in Hospitalized Oncogeriatric Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Hospital Acquired Condition
Debility
Aging
Keywords: Multicomponent exercise
Oncogeriatric
Hospitalization
Lead sponsor: Fundacion Miguel Servet
Sponsor class: OTHER
First posted: 2022-06-21
Enrollment: 58
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: PREVENTION

Brief summary: Hospitalized older patients usually remain bedridden for many hours and this may lead to the appearance of unwanted negative consequences, such as cognitive or physical decline upon discharge. Our study will analyze whether an intervention consisting of a multicomponent training programme applied to patients over the age of 60 who are hospitalized for acute medical conditions in an Oncology Department of a tertiary hospital improves functional capacity and cognitive function. A total of 50 hospitalized older adult patients will be recruited in the Hospital Universitario de Navarra, Pamplona, Spain. The participants will be randomized and included in an exercise intervention (n = 25) or a control (n = 25) group (hospital usual-care). The intervention consists of a multicomponent exercise training programme that will take place for 3 consecutive days (2 sessions/day). The control group will receive usual hospital care, which will include physical rehabilitation when needed. Functional and cognitive impairment after and during acute hospitalization in older adults are major determinants of the later need for health resources. If our hypothesis is correct and shows that a multicomponent, individualized and progressive exercise programme is an effective therapy for improving the functional capacity of acutely hospitalized older patients compared to usual care, a change in the current system of hospitalization may be justified in oncogeriatric patients with medical conditions


Eligibility criteria: Inclusion Criteria:

* Age \> 65 years
* Barthel Index ≥60 points
* Able to ambulate (with/without assistance)
* Sign the informed consent
* Able to communicate

Exclusion Criteria:

* Expected length of stay \< 6 days
* Terminal illness
* Very severe cognitive decline (i.e., GDS 7)
* Uncontrolled arrhythmias, acute pulmonary embolism, acute myocardial infarction or limb bone fracture in the past 3 months.

Primary outcomes:
measure: Change in functional capacity: Short Physical Performance Battery test (SPPB; Spanish versión)
timeFrame: 12 months
measure: Change in cognitive function: Minimental State Evaluation (MMSE; Spanish version)
timeFrame: 12 months
Secondary outcomes:
measure: Change in functional capacity: Barthel Index (spanish version)
timeFrame: 12 months
measure: Changes in handgrip strength (dominant hand)
timeFrame: 12 months
measure: Gait ability will be assessed using the 6-metre gait velocity test (GVT)
timeFrame: 12 months
measure: Changes in mood status: the 15-item Yesavage Geriatric Depression Scale (GDS-VE), Spanish version
timeFrame: 12 months
measure: Changes in the Trail Making Test (TMT) part A
timeFrame: 12 months
measure: Dual task GVT (verbal GVT and arithmetic GVT)
timeFrame: 12 months
measure: Changes in the quality of life measured by the Spanish version of the EuroQol-5 Dimension (EQ-5D) questionnaire
timeFrame: 12 months
Other outcomes:
Locations:
city: Pamplona
country: Spain
facility: Hospital Universitario de Navarra
state: Navarra
Study officials:
affiliation: Hospital of Navarra
name: NICOLA MARTINEZ-VELILLA, PhD
role: PRINCIPAL_INVESTIGATOR
References: