Benefit of prehabilitation exercise program on moderate to high risk elderly patients undergoing open abdominal surgery : Randomized controlled trial

Phase 1

• Conditions: Moderate to high risk elderly patients undergoing open abdominal surgery; Prehabilitation; Elderly; Open abdominal surgery; Functional capacity; Surgical outcome

• Registration Number: TCTR20210311008
• Lead Sponsor: Faculty of medicine Siriraj hospital, Mahidol university

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-03-11
• Study Completion: 2024-07-05
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Enrolling by invitation
• Sex: All
• Target Recruitment: 140

Inclusion Criteria

1. Elective surgery patient appointed for open abdominal surgery
2. Stable medical condition
3. Able to walk at least 10 meters without assistant
4. Have preparing period to exercise follow the protocol before operation at least 2 weeks (14 days)
5. Able to visit hospital for follow-up at 1, 3, 6 months after surgery

Exclusion Criteria

1. Have active cardiac condition(s) within 1 month prior to enrolment day
(Active cardiac condition including Unstable angina, Symptomatic severe aortic stenosis, Congestive heart failure)
2. Patient with cardiac implants
3. Low risk surgical patient (Assessed as classification I by American Society of Anesthesiologists physical status)
4. Disability in musculoskeletal or neurological system causing unable to exercise follow the research protocol
5. Diagnosed with Psychotic disorder or dementia (According to the medical records)
6. Impairment in visual or auditory system affecting safety to exercise
7. Diagnosed with Chronic Obstructive Pulmonary Disease:(COPD) GOLD grade 3-4 (According to the medical records)
Assessed by : 1) Pulmonary function tes result : Forced expiratory volume in the first second of expiration (FEV1) <50% predicted
2) Exacerbation of disease which require hospital visit >= 2 visits/year
3) Exacerbation of disease which require hospital admission >= 1 visit/year
8. Anemic condition in which Hemoglobin level < 7.0 g/dL on the enrolment day
9. Operation including vascular surgery or organ transplantation

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Functional capacity 1 month after surgery 6 minutes walk test

Secondary Outcome Measures

Name	Time	Method
pper extremities strength 1 moth after surgery 30 seconds arm curl test,Lower extremities strength 1 moth after surgery 30 seconds sit to stand test,Lean muscle mass 1 moth after surgery Bioelectrical impedance analysis,Post-operative morbidity 30 days after surgery Comprehensive Complication Index,Pulmonary complication 7 days after surgery European Perioperative Clinical Outcome(EPCO),Length of primary hospital stay The day patient discharge from hospital Length of primary hospital stay,Readmission rate 3 months after surgery Readmission rate,Basic activities of daily living 1 moth after surgery Barthel index,Instrumental activities of daily living 1 moth after surgery Lawton IADL,Quality of life 1 moth after surgery Euro-QoL-5D-5L,Anxiety and depression 1 moth after surgery Hospital anxiety and depression scale