Clinical trial NCT05290532: Effect of Multimodal Postoperative Rehabilitation on Functional and Cognitive Decline
Official title: Effect of Multimodal Postoperative Rehabilitation on Functional and Cognitive Decline, in Elderly Patients Undergoing Urgent Abdominal Surgery: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Surgery--Complications
Keywords: Elderly patients
Exercises
Cognitive Dysfunction
Quality of life
Lead sponsor: Hospital of Navarra
Sponsor class: OTHER
Collaborators: name: Fundacion Miguel Servet
First posted: 2022-03-22
Enrollment: 218
Sex: ALL
Minimum age (years): 70
Maximum age (years): 105
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a randomized clinical trial,patient who meet the inclusion criteria will be randomly assigned to the intervention or control group
Primary purpose: PREVENTION

Brief summary: Older adults, especially those with frailty, have a higher risk for complications, functional and cognitive decline after urgent surgery.

These patients have their functional and physiological reserve reduced which makes them more vulnerable to the effects of being bedridden. The consequences are at multiple levels emphasizing the functional loss or cognitive impairment, longer stays, mortality and institutionalization, delirium, poor quality of life and increased use of resources related to health. Exercise training can prevent functional and cognitive decline and modify even the posterior trajectory

Detailed description: This study is a randomized clinical trial conducted in the Department of Surgery of a tertiary public hospital. Patients undergoing urgent abdominal surgery who meet inclusion criteria will be randomly assigned to the intervention or control group. A total of 218 elderly patients undergoing urgent abdominal surgery( control group=109 and intervention group 109) randomly assigned to the intervention or control group.

Patient recruitment will begin in the 4-day after the surgical procedure, which will be identified through the list of patients admitted to the hospital and assigned to the Department. The doctor who decides the inclusion in the intervention or control group will not be the attending physician. Patients or their families (if the patient has cognitive impairment) will be informed of the random inclusion in one group, but will not be informed as to which they belong. Randomization will be performed by applying http://www.randomizer.org/. The information in both the intervention group and the control group will obtained in four different stages: the initial visit and at months 1, 3 and 6 after hospital discharge.

The intervention will consist of a multicomponent exercise training program, which will composed of supervised progressive resistance exercise training, aerobic and anaerobic exercises. This training period consist on 2 training sessions per week during 4 weeks after one week of discharge.

Eligibility criteria: Inclusion Criteria:

* Age 70 years and older
* Able to tolerate exercise
* Able to ambulate, with or without personal / technical assistance or move unassisted in a wheelchair
* Able to communicate
* Undergoing urgent abdominal surgery
* Barthel Index\>60
* Informed consent: must be capable and willing to provide consent

Exclusion Criteria:

* Severe dementia (GDS 7)
* Duration of hospitalization \<4 days
* Unwillingness to either complete the study requirements or to be randomized into control or intervention group
* Unstable cardiovascular disease or other unstable medical condition
* Terminal illness
* Myocardial infarction in the past 3 months
* Upper or lower extremity fracture in the past 3 months
* Evisceration

Primary outcomes:
measure: Changes in functional capacity of patients
timeFrame: 1, 3 and 6 months after hospitalization discharge
measure: Changes in Cognitive capacity of patients
timeFrame: 1, 3 and 6 months after hospitalization discharge
measure: Changes in Quality of life
timeFrame: 1, 3 and 6 months after hospitalization discharge
measure: Changes in Visual Analogue Scale
timeFrame: 1, 3 and 6 months after hospitalization discharge
Secondary outcomes:
measure: Postoperative complications
timeFrame: 30 and 90-day
measure: Length of stay
timeFrame: from the date of admission until the date of discharge
measure: Mortality
timeFrame: 30 and 90-day
measure: Delirium
timeFrame: from the date of admission until the date of discharge
measure: Cost per quality-adjusted life year
timeFrame: 6 months post-discharge
Other outcomes:
Locations:
Study officials:
affiliation: Hospital of Navarra
name: IRENE ESQUIROZ, MBBS
role: PRINCIPAL_INVESTIGATOR
References: