Effect of Multimodal Postoperative Rehabilitation on Functional and Cognitive Decline

Effect of Multimodal Postoperative Rehabilitation on Functional and Cognitive Decline, in Elderly Patients Undergoing Urgent Abdominal Surgery: A Randomized Clinical Trial

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

Study Overview

• Status: Not yet recruiting
• Conditions: Surgery--Complications
• Intervention / Treatment: Other: Individualized exercise training

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.

• Study Type: Interventional
• Enrollment (Anticipated): 218
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Inés E Córdoba, MD; Phone Number: 666909487; Email: ineseguaras@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 70 years to 105 years (Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Individualized exercise training; Exercise training. Individual program training 2 days per week during 4 week, after one week of discharge	Other: Individualized exercise training; 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 of 40 minutes (Warm up 5´+ aerobic exercise 15´+ anaerobic exercise 15´+ stretching 5´)per week during 4 weeks after one week of discharge
No Intervention: No Intervention: Control; Usual care including rehabilitation when necessary

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in functional capacity of patients	The functional capacity of patients will be evaluated by the Short Physical Performance Battery (SPPB), which evaluates, balance, gait ability, and leg strength using a single tool. The total score will range from 0 (worst) to 12 points (best).	1, 3 and 6 months after hospitalization discharge
Changes in Cognitive capacity of patients	The cognitive-affective status will be measured in the follow up using the Mini Mental State Examination.nThis examination is composed of seven categories designed to assess specific cognitive functions: orientation to time (5 points), orientation to place (5 points), registration of three words (3 points), attention and calculation (5 points), recalling the three words (3 points), language (8 points) and constructive visual capacity (1 point). The MMSE score ranges from zero to 30 points, and lower values indicate possible cognitive deficit	1, 3 and 6 months after hospitalization discharge
Changes in Quality of life	Changes in Quality of life will be evaluated by European Quality of Life-5 Dimensions (EuroQol- 5D). European Quality of Life-5 Dimensions: comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels, the score will range from 5 (wort) to 15 (best).	1, 3 and 6 months after hospitalization discharge
Changes in Visual Analogue Scale	Changes in Visual Analogue Scale (VAS). The VAS records the patient's self-rated health on a vertical visual analogue scale, where the endpoints are labelled 'The best health you can imagine' (100 points) and 'The worst health you can imagine'(0 points).	1, 3 and 6 months after hospitalization discharge

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative complications	Comprehensive Complication Index	30 and 90-day
Length of stay	Length of stay	from the date of admission until the date of discharge
Mortality	postoperative mortality	30 and 90-day
Delirium	Confusion Assessment Method (CAM) The CAM short form assesses four features: 1. acute onset or fluctuating course, 2. inattention, 3. disorganized thinking, and 4. altered level of consciousness. For the diagnosis of delirium, the first two criteria and at least one of the last two are necessary.	from the date of admission until the date of discharge
Cost per quality-adjusted life year	Both direct and indirect study participant costs	6 months post-discharge

Collaborators and Investigators

• Sponsor: Hospital of Navarra
• Collaborators: Fundacion Miguel Servet
• Investigators: Principal Investigator: IRENE ESQUIROZ, MBBS, Hospital of Navarra

Study record dates

Study Major Dates

• Study Start (Anticipated): April 1, 2022
• Primary Completion (Anticipated): April 30, 2024
• Study Completion (Anticipated): April 1, 2025

Study Registration Dates

• First Submitted: February 10, 2022
• First Submitted That Met QC Criteria: March 13, 2022
• First Posted (Actual): March 22, 2022

Study Record Updates

• Last Update Posted (Actual): March 22, 2022
• Last Update Submitted That Met QC Criteria: March 13, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: Quality of life; Elderly patients; Exercises; Cognitive Dysfunction
• Additional Relevant MeSH Terms: Mental Disorders; Neurocognitive Disorders; Cognition Disorders; Cognitive Dysfunction
• Other Study ID Numbers: Hospital de Navarra

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No