Effect of Multimodal Postoperative Rehabilitation on Functional and Cognitive Decline

NCT05290532 | Unknown DMC

• 1 other identifier: Hospital de Navarra
• Study Type: interventional
• Target: 218
• Locations: 0 countries
• Sites: N/A

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

Conditions

Surgery--Complications

Keywords

Elderly patients; Exercises; Cognitive Dysfunction; Quality of life

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (5)

• Postoperative complications

  30 and 90-day

• Length of stay

  from the date of admission until the date of discharge

• Mortality

  30 and 90-day

• Delirium

  from the date of admission until the date of discharge

• Cost per quality-adjusted life year

  6 months post-discharge

Study Arms (2)

Individualized exercise training

OTHER

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

Other: Individualized exercise training

No Intervention: Control

NO INTERVENTION

Usual care including rehabilitation when necessary

Interventions

Individualized exercise training 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

Individualized exercise training

Eligibility Criteria

• Age: 70 Years - 105 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital of Navarra: lead
• Fundacion Miguel Servet: collaborator

Related Publications (1)

• 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.

  PMID: 39232792 DERIVED

MeSH Terms

Conditions

Motor Activity; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Behavior; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• IRENE ESQUIROZ, MBBS

  Hospital of Navarra

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Inés E Córdoba, MD

CONTACT

666909487; ineseguaras@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: The study participants will be randomized ( ww. randomizer.org) into an intervention group and a control group. the assessment staff will be blinded to the participant randomization assignment, as well as to the main study design ant to what changes we expect to occur in the study outcomes in either group. It will not be possible to conceal the group assignment from the staff involved in the training of the intervention group.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: This is a randomized clinical trial,patient who meet the inclusion criteria will be randomly assigned to the intervention or control group

Study Record Dates

• First Submitted: February 10, 2022
• First Posted: March 22, 2022
• Study Start: April 1, 2022
• Primary Completion: April 30, 2024
• Study Completion: April 1, 2025
• Last Updated: March 22, 2022

Record last verified: 2022-03