Effect of Multimodal Postoperative Rehabilitation on Functional and Cognitive Decline

NCT ID: NCT05290532

Last Updated: 2022-03-22

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 218 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-01
• Study Completion Date: 2025-04-01

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.

Conditions

Surgery--Complications

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Individualized exercise training

Exercise training. Individual program training 2 days per week during 4 week, after one week of discharge

Group Type: OTHER

Individualized exercise training

Intervention Type: OTHER

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: Control

Usual care including rehabilitation when necessary

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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

Intervention Type: OTHER

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

• Minimum Eligible Age: 70 Years
• Maximum Eligible Age: 105 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Fundacion Miguel Servet

OTHER

Sponsor Role: collaborator

Hospital of Navarra

OTHER

Sponsor Role: lead

Responsible Party

IRENE ESQUIROZ

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

IRENE ESQUIROZ, MBBS

Role: PRINCIPAL_INVESTIGATOR

Hospital of Navarra

Central Contacts

Inés E Córdoba, MD

Role: CONTACT

ineseguaras@hotmail.com

666909487

References

Esquiroz Lizaur I, Zambom-Ferraresi F, Zambom-Ferraresi F, Ollo-Martinez I, De la Casa-Marin A, Martinez-Velilla N, Recreo Baquedano A, Galbete Jimenez A, Gonzalez Alvarez G, Yarnoz Irazabal MC, Eguaras Cordoba I. Postoperative physical rehabilitation in the elderly patient after emergency surgery. Influence on functional, cognitive and quality of live recovery: study protocol for a randomized clinical trial. Trials. 2024 Sep 4;25(1):584. doi: 10.1186/s13063-024-08406-0.

Reference Type: DERIVED

PMID: 39232792 (View on PubMed)

Other Identifiers

Hospital de Navarra

Identifier Type: -

Identifier Source: org_study_id