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Surgery--ComplicationsNCT05290532

Effect of Multimodal Postoperative Rehabilitation on Functional and Cognitive Decline

A study testing Individualized exercise training in people with Surgery--Complications, run by Hospital of Navarra.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 70 to 105 yearsHealthy volunteers can take part
Conditions the study is for
Surgery--Complications
What is being tested?
Individualized exercise training
Could I receive a placebo?
No, everyone receives an active treatment
How many people
218 participants
Where
No sites listed yet
Study dates
1 Apr 2022to 1 Apr 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 70 to 105 years
  • All sexes
  • Healthy volunteers accepted
  • Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

No sites are listed yet.

Inés E Córdoba, MD contact

666909487

ineseguaras@hotmail.com

About this study

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

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

Read the 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.

Being tested
Individualized exercise training
Keywords
Elderly patients, Exercises, Cognitive Dysfunction, Quality of life
Medical subject headings
Motor Activity, Cognitive Dysfunction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Individualized exercise trainingOther

    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

Study groups in NCT05290532
Study groupRoleWhat they receive
Individualized exercise trainingOtherExercise training. Individual program training 2 days per week during 4 week, after one week of discharge
Receives: Other: Individualized exercise training
No Intervention: ControlNo interventionUsual care including rehabilitation when necessary

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: 1, 3 and 6 months after hospitalization discharge

  2. 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

    Measured: 1, 3 and 6 months after hospitalization discharge

  3. 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).

    Measured: 1, 3 and 6 months after hospitalization discharge

  4. 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).

    Measured: 1, 3 and 6 months after hospitalization discharge

Secondary outcomes (5)

  1. Postoperative complications

    Comprehensive Complication Index

    Measured: 30 and 90-day

  2. Length of stay

    Length of stay

    Measured: from the date of admission until the date of discharge

  3. Mortality

    postoperative mortality

    Measured: 30 and 90-day

  4. 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.

    Measured: from the date of admission until the date of discharge

  5. Cost per quality-adjusted life year

    Both direct and indirect study participant costs

    Measured: 6 months post-discharge

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Mar 2022
  2. Study start1 Apr 2022 (estimated)
  3. Primary completion30 Apr 2024 (estimated)
  4. Study completion1 Apr 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
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
Single blind
Who is masked
Investigator
Enrolment
218 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05290532
Sponsor's protocol ID
Hospital de Navarra
Status last verified
Mar 2022
First submitted
10 Feb 2022
Last updated
22 Mar 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 39232792

Questions about this trial

What is this clinical trial studying?

A study testing Individualized exercise training in people with Surgery--Complications, run by Hospital of Navarra.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 22 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Inés E Córdoba, MD (666909487, ineseguaras@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes in functional capacity of patients (time frame: 1, 3 and 6 months after hospitalization discharge). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05290532, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2022.

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