Effect of Multimodal Postoperative Rehabilitation on Functional and Cognitive Decline

Hospital of Navarra

Status: Not yet enrolling

Conditions: Surgery--Complications

Treatments: Other: Individualized exercise training

Study type: Interventional

Funder types: Other

Identifiers

NCT05290532

Hospital de Navarra

Details and patient eligibility

About

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

Full 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.

Enrollment: 218 estimated patients

Sex: All

Ages: 70 to 105 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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218 participants in 2 patient groups

Individualized exercise training

Other group

Description:

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

Treatment:

Other: Individualized exercise training

No Intervention: Control

No Intervention group

Description:

Usual care including rehabilitation when necessary