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

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
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
NCT ID
NCT05290532
First Posted
February 10, 2022
Last Updated
March 13, 2022
Sponsor
Hospital of Navarra
Collaborators
Fundacion Miguel Servet
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
Learn more about this trial
Effect of Multimodal Postoperative Rehabilitation on Functional and Cognitive Decline
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