Clinical trial NCT04593134: Effectiveness of Exercise Program in Improving Quality of Life in Patients With Gastric Cancer Undergoing Gastrectomy
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Gastric Cancer
Keywords: gastrectomy
fatigue
anxiety
depression
sleep quality
Quality of Life
Lead sponsor: Taipei Veterans General Hospital, Taiwan
Sponsor class: OTHER_GOV
First posted: 2020-10-19
Enrollment: 160
Sex: ALL
Minimum age (years): 20
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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:

1. The fatigue in exercise group is significant improving than usual-care group at 1st, 2nd, 3rd, 6th, 12th, 24th and 36th month.
2. The negative emotions in exercise group is significant improving than usual-care group at 1st, 2nd, 3rd, 6th, 12th, 24th and 36th month.
3. The sleep quality in exercise group is significant improving than usual-care group at 1st, 2nd, 3rd, 6th, 12th, 24th and 36th month.
4. 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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

1. Suspected or confirmed bone metastasis.
2. 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.
3. Poorly diabetes controlled, glycosylated hemoglobin (HbA1C)\>9%, blood sugar higher than 250mg/dl or lower than 80mg/dl.
4. 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.
5. Diagnosed as recurrent depression.
6. Regular exercise above moderate intensity, such as 150 minutes per week in the past three months.

Primary outcomes:
measure: Quality of Life (EORTC QLQ-C30 )
timeFrame: baseline (one week after recruited)
measure: Quality of Life (EORTC QLQ-C30 )
timeFrame: 1st month after recruited
measure: Quality of Life (EORTC QLQ-C30)
timeFrame: 2nd month after recruited
measure: Quality of Life (EORTC QLQ-C30)
timeFrame: 3rd month after recruited
measure: Quality of Life (EORTC QLQ-C30)
timeFrame: 6th month after recruited
measure: Quality of Life (EORTC QLQ-C30)
timeFrame: 12th month after recruited
measure: Quality of Life (EORTC QLQ-C30)
timeFrame: 24th month after recruited
measure: Quality of Life (EORTC QLQ-C30)
timeFrame: 36th month after recruited
measure: Quality of Life (EORTC QLQ-STO22)
timeFrame: baseline (one week after recruited)
measure: Quality of Life (EORTC QLQ-STO22)
timeFrame: 1st month after recruited
measure: Quality of Life (EORTC QLQ-STO22)
timeFrame: 2nd month after recruited
measure: Quality of Life (EORTC QLQ-STO22)
timeFrame: 3rd month after recruited
measure: Quality of Life (EORTC QLQ-STO22)
timeFrame: 6th month after recruited
measure: Quality of Life (EORTC QLQ-STO22)
timeFrame: 12th month after recruited
measure: Quality of Life (EORTC QLQ-STO22)
timeFrame: 24th month after recruited
measure: Quality of Life (EORTC QLQ-STO22)
timeFrame: 36th month after recruited
Secondary outcomes:
measure: fatigue(Brief Fatigue Inventory-Taiwan , BFI-T)
timeFrame: baseline (one week after recruited)
measure: fatigue(Brief Fatigue Inventory-Taiwan , BFI-T)
timeFrame: 1st month after recruited
measure: fatigue(Brief Fatigue Inventory-Taiwan , BFI-T)
timeFrame: 2nd month after recruited
measure: fatigue(Brief Fatigue Inventory-Taiwan , BFI-T)
timeFrame: 3rd month after recruited
measure: fatigue(Brief Fatigue Inventory-Taiwan , BFI-T)
timeFrame: 6th month after recruited
measure: fatigue(Brief Fatigue Inventory-Taiwan , BFI-T)
timeFrame: 12th month after recruited
measure: fatigue(Brief Fatigue Inventory-Taiwan , BFI-T)
timeFrame: 24th month after recruited
measure: fatigue(Brief Fatigue Inventory-Taiwan , BFI-T)
timeFrame: 36th month after recruited
measure: Emotional distress( Hospital Anxiety and Depression Scale, HADS)
timeFrame: baseline (one week after recruited)
measure: Emotional distress( Hospital Anxiety and Depression Scale, HADS)
timeFrame: 1st month after recruited
measure: Emotional distress( Hospital Anxiety and Depression Scale, HADS)
timeFrame: 2nd month after recruited
measure: Emotional distress( Hospital Anxiety and Depression Scale, HADS)
timeFrame: 3rd month after recruited
measure: Emotional distress( Hospital Anxiety and Depression Scale, HADS)
timeFrame: 6th month after recruited
measure: Emotional distress( Hospital Anxiety and Depression Scale, HADS)
timeFrame: 12th month after recruited
measure: Emotional distress( Hospital Anxiety and Depression Scale, HADS)
timeFrame: 24th month after recruited
measure: Emotional distress( Hospital Anxiety and Depression Scale, HADS)
timeFrame: 36th month after recruited
measure: sleep quality(Pittsburgh Sleep Quality Index and using Actigraph)
timeFrame: baseline (one week after recruited)
measure: sleep quality(Pittsburgh Sleep Quality Index and using Actigraph)
timeFrame: 3rd month after recruited
measure: sleep quality(Pittsburgh Sleep Quality Index and using Actigraph)
timeFrame: 6th month after recruited
measure: sleep quality(Pittsburgh Sleep Quality Index and using Actigraph)
timeFrame: 12th month after recruited
measure: sleep quality(Pittsburgh Sleep Quality Index and using Actigraph)
timeFrame: 24th month after recruited
measure: sleep quality(Pittsburgh Sleep Quality Index and using Actigraph)
timeFrame: 36th month after recruited
measure: Circadian rhythms(using Actigraph)
timeFrame: baseline (one week after recruited)
measure: Circadian rhythms(using Actigraph)
timeFrame: 3rd month after recruited
measure: Circadian rhythms(using Actigraph)
timeFrame: 6th month after recruited
measure: Circadian rhythms(using Actigraph)
timeFrame: 12th month after recruited
measure: Circadian rhythms(using Actigraph)
timeFrame: 24th month after recruited
measure: Circadian rhythms(using Actigraph)
timeFrame: 36th month after recruited
Other outcomes:
Locations:
city: Taipei county
country: Taiwan
facility: Taipei Veterans General Hospital
Study officials:
affiliation: National Taipei University of Nursing and Health Sciences, Taipei, Taiwan
name: Hui-Mei Chen, PhD
role: STUDY_CHAIR
References: