The Effect of Home Based Walking Exercise on Fatigue, Anxiety, Depression, Sleep Quality, Circadian Rhythms and Quality of Life in Patients With Gastric Cancer Undergoing Gastrectomy

Taipei Veterans General Hospital, Taiwan1 site in 1 country160 target enrollmentNovember 10, 2020

Overview

Brief Summary

This study will investigate the effectiveness of a rehabilitation program in improving fatigue, negative emotions , sleep quality, circadian rhythms and quality of life in patients with gastric cancer undergoing gastrectomy in Taiwan.

Hypothesis:

The fatigue in exercise group is significant improving than usual-care group at 1st, 2nd, 3rd, 6th, 12th, 24th and 36th month.
The negative emotions in exercise group is significant improving than usual-care group at 1st, 2nd, 3rd, 6th, 12th, 24th and 36th month.
The sleep quality in exercise group is significant improving than usual-care group at 1st, 2nd, 3rd, 6th, 12th, 24th and 36th month.
The quality of life in exercise group is significant improving than usual-care group at 1st, 2nd,3rd, 6th, 12th, 24th and 36th month.

Detailed Description

This study will investigate the effectiveness of a rehabilitation program in improving fatigue, negative emotions , sleep quality, circadian rhythms and quality of life in patients with gastric cancer undergoing gastrectomy in Taiwan.

Registry

clinicaltrials.gov

Start Date

November 10, 2020

End Date

October 31, 2025

Last Updated

4 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Taipei Veterans General Hospital, Taiwan

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•After undergoing surgery and clinically diagnosed as gastric cancer.
•Adults over 20 years old.
•Hemoglobin (above 10 g/dL).
•Clear consciousness and could communicate in either Mandarin or Taiwanese, and were not cognitively impaired were included.
•No lower limb disability and able to walk on their own.

Exclusion Criteria

•Suspected or confirmed bone metastasis.
•Poorly controlled cardiovascular disease such as heart failure, arrhythmia, angina, myocardial infarction, chest pain during activities or rest in the past three months, and valvular heart disease using anticoagulants.
•Poorly diabetes controlled, glycosylated hemoglobin (HbA1C)\>9%, blood sugar higher than 250mg/dl or lower than 80mg/dl.
•Those with poor blood pressure control, systolic blood pressure greater than 160mmHg or diastolic blood pressure than 100mmHg when quiet, and heart rate is greater than 100bpm when quiet.
•Diagnosed as recurrent depression.
•Regular exercise above moderate intensity, such as 150 minutes per week in the past three months.

Outcomes

Primary Outcomes

Quality of Life (EORTC QLQ-C30 )

Time Frame: 1st month after recruited

The EORTC QLQ-C30 :This scale is measured by the respondent self-assessed the frequency of various problems in the past week. The EORTC QLQ-C30 consists of three subscales with 30 questions. The EORTC QLQ-C30 have three subscales in the scale include functioning scales (15 questions), symptom scales (13 questions), and global health status (2 questions). The reliability and validity of Cronbach'α was 0.81-0.94. The functional scale and the global health status , the higher the total score, the better the quality of life; the lower the score in the symptom scale, the better the quality of life.

Quality of Life (EORTC QLQ-C30)

Time Frame: 36th month after recruited

The EORTC QLQ-C30 :This scale is measured by the respondent self-assessed the frequency of various problems in the past week. The EORTC QLQ-C30 consists of three subscales with 30 questions. The EORTC QLQ-C30 have three subscales in the scale include functioning scales (15 questions), symptom scales (13 questions), and global health status (2 questions). The reliability and validity of Cronbach'α was 0.81-0.94. The functional scale and the global health status , the higher the total score, the better the quality of life; the lower the score in the symptom scale, the better the quality of life.

Quality of Life (EORTC QLQ-STO22)

Time Frame: 36th month after recruited

The EORTC QLQ-STO22:This scale is measured by the respondent self-assessed the frequency of various problems in the past week. The EORTC QLQ-STO22 consists of one subscale with 22 questions.The EORTC QLQ-STO22 scale include symptom scales (22 questions) The Cronbach'α was 0.70-0.94.The lower the score in the symptom scale, the better the quality of life.

Secondary Outcomes

fatigue(Brief Fatigue Inventory-Taiwan , BFI-T)(36th month after recruited)
Emotional distress( Hospital Anxiety and Depression Scale, HADS)(36th month after recruited)
Circadian rhythms(using Actigraph)(36th month after recruited)
sleep quality(Pittsburgh Sleep Quality Index and using Actigraph)(36th month after recruited)