Effect of Multimodal Postoperative Rehabilitation on Functional and Cognitive Decline

Surgery--Complications Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05290532
• Other study ID #: Hospital de Navarra
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 1, 2022
• Est. completion date: April 1, 2025

Study information

• Verified date: March 2022
• Source: Hospital of Navarra
• Contact: Inés E Córdoba, MD
• Phone: 666909487
• Email: ineseguaras[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 218
• Est. completion date: April 1, 2025
• Est. primary completion date: April 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 70 Years to 105 Years

Eligibility

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

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Surgery--Complications

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Hospital of Navarra	Fundacion Miguel Servet

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	Postoperative complications	Comprehensive Complication Index	30 and 90-day
Secondary	Length of stay	Length of stay	from the date of admission until the date of discharge
Secondary	Mortality	postoperative mortality	30 and 90-day
Secondary	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
Secondary	Cost per quality-adjusted life year	Both direct and indirect study participant costs	6 months post-discharge