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Multicomponent Prehabilitation and Outcomes in Elderly Patients With Frailty

NCT04715581 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 540

Last updated 2025-07-31

No results posted yet for this study

Summary

The study is designed to investigate the effect of a multicomponent prehabilitation pathway on early and long-term outcomes in elderly patients with frailty recovering from surgery for digestive cancer.

Conditions

  • Old Age; Debility
  • Digestive Cancer
  • Surgery
  • Preoperative Rehabilitation
  • Nutrition Therapy
  • Outcomes

Interventions

DIETARY_SUPPLEMENT

Preoperative nutritional optimization

1. Indication for oral nutritional supplementation: Patients at risk of malnutrition (MNA-SF 8-11) or with malnutrition (MNA-SF 0-7). 2. Protocol of nutritional optimization: Enteral nutritional powder (Ensure for patients without diabetes and Glucerna for patients with diabetes) twice a day. The target protein intake is 1.5-1.8 g/kg/d. Patients with iron deficient anemia (hemoglobin \<130 g/L for men and \<120 g/L for women) will be given oral iron therapy. 3. The duration of nutritional optimization: The day admitted to the hospital to the surgery to one day prior to the surgery.

BEHAVIORAL

Preoperative exercise training

1. The respiratory training will be performed for at least 2-3 times per day. Respiratory training include thoracic breathing exercise and cough training. 2. Aerobic exercise will be performed for at least 1-2 times per day. Aerobic exercise includes jogging, walking or climbing stairs. Exercise intensity will be based on patients' tolerance. The goal of the training is to complete the training plan as far as possible. 3. Every training should be last for 45 minutes to 1 hour. If the patient can not tolerate, the training time should be reduce to 30 minutes. 4. The duration of exercise training: The day admitted to the hospital to the surgery to one day prior to the surgery.

BEHAVIORAL

Postoperative exercise training

1. Muscle strength training in the bedside and walking in the ward. 2. Aerobic exercise includes jogging, walking or climbing stairs. Exercise intensity will be based on patients' tolerance. The goal of the training is to complete the training plan as far as possible. 3. Exercise training is performed under the supervision of physiotherpists durign hospital stay, and is reminded by regular telephone calls and phone messages after hospital discharge.

Sponsors & Collaborators

  • Peking University First Hospital

    lead OTHER

Principal Investigators

  • Dong-Xin Wang, MD, PhD · Peking University First Hospital

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
65 Years
Max Age
89 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-11-25
Primary Completion
2026-12-31
Completion
2028-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04715581 on ClinicalTrials.gov