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Effect of Multimodal Postoperative Rehabilitation on Functional and Cognitive Decline

Primary Purpose

Surgery--Complications

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Individualized exercise training
Sponsored by
Hospital of Navarra
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Surgery--Complications focused on measuring Elderly patients, Exercises, Cognitive Dysfunction, Quality of life

Eligibility Criteria

70 Years - 105 Years (Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Other

    No Intervention

    Arm Label

    Individualized exercise training

    No Intervention: Control

    Arm Description

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

    Usual care including rehabilitation when necessary

    Outcomes

    Primary Outcome Measures

    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).
    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
    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).
    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).

    Secondary Outcome Measures

    Postoperative complications
    Comprehensive Complication Index
    Length of stay
    Length of stay
    Mortality
    postoperative mortality
    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.
    Cost per quality-adjusted life year
    Both direct and indirect study participant costs

    Full Information

    First Posted
    February 10, 2022
    Last Updated
    March 13, 2022
    Sponsor
    Hospital of Navarra
    Collaborators
    Fundacion Miguel Servet
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05290532
    Brief Title
    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

    2. Study Status

    Record Verification Date
    March 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    April 1, 2022 (Anticipated)
    Primary Completion Date
    April 30, 2024 (Anticipated)
    Study Completion Date
    April 1, 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Hospital of Navarra
    Collaborators
    Fundacion Miguel Servet

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Surgery--Complications
    Keywords
    Elderly patients, Exercises, Cognitive Dysfunction, Quality of life

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    This is a randomized clinical trial,patient who meet the inclusion criteria will be randomly assigned to the intervention or control group
    Masking
    Investigator
    Masking Description
    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.
    Allocation
    Randomized
    Enrollment
    218 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Individualized exercise training
    Arm Type
    Other
    Arm Description
    Exercise training. Individual program training 2 days per week during 4 week, after one week of discharge
    Arm Title
    No Intervention: Control
    Arm Type
    No Intervention
    Arm Description
    Usual care including rehabilitation when necessary
    Intervention Type
    Other
    Intervention Name(s)
    Individualized exercise training
    Intervention Description
    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
    Primary Outcome Measure Information:
    Title
    Changes in functional capacity of patients
    Description
    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).
    Time Frame
    1, 3 and 6 months after hospitalization discharge
    Title
    Changes in Cognitive capacity of patients
    Description
    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
    Time Frame
    1, 3 and 6 months after hospitalization discharge
    Title
    Changes in Quality of life
    Description
    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).
    Time Frame
    1, 3 and 6 months after hospitalization discharge
    Title
    Changes in Visual Analogue Scale
    Description
    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).
    Time Frame
    1, 3 and 6 months after hospitalization discharge
    Secondary Outcome Measure Information:
    Title
    Postoperative complications
    Description
    Comprehensive Complication Index
    Time Frame
    30 and 90-day
    Title
    Length of stay
    Description
    Length of stay
    Time Frame
    from the date of admission until the date of discharge
    Title
    Mortality
    Description
    postoperative mortality
    Time Frame
    30 and 90-day
    Title
    Delirium
    Description
    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.
    Time Frame
    from the date of admission until the date of discharge
    Title
    Cost per quality-adjusted life year
    Description
    Both direct and indirect study participant costs
    Time Frame
    6 months post-discharge

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    70 Years
    Maximum Age & Unit of Time
    105 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Inés E Córdoba, MD
    Phone
    666909487
    Email
    ineseguaras@hotmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    IRENE ESQUIROZ, MBBS
    Organizational Affiliation
    Hospital of Navarra
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

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    Effect of Multimodal Postoperative Rehabilitation on Functional and Cognitive Decline

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