Effectiveness of Exercise Program in Improving Quality of Life in Patients With Gastric Cancer Undergoing Gastrectomy

NCT ID: NCT04593134

Last Updated: 2021-12-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-10

Study Completion Date

2025-10-31

Brief Summary

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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

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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.

Conditions

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Gastric Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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exercise group

A 12-week regimen of home-based walking exercises, comprising walking at a moderate intensity for 40 min, three times a Week.

Group Type EXPERIMENTAL

exercise group

Intervention Type BEHAVIORAL

exercise education: A 12-week regimen of homebased walking exercises, include moderate intensity for 40 min, three times a week.

We explained the participants how to perform the exercises, according to an instruction manual for the exercise regimen. Participants were instructed that the exercises would be effective only if they reached 40%-60% of the heart rate reserve, as determined by the Karvonen method, or 13-14 on the RPE.

Exercise education:

Weekly telephone or mobile application "LINE" consultations concerning exercise.we discussed whether participants' exercise fulfilled the prescribed intensity, duration, frequency and whether the participants experienced any adverse effects.

usual-care group

These participants follows the standard post-surgery follow-up consisting of counseling by dietitians, nurses and doctors.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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exercise group

exercise education: A 12-week regimen of homebased walking exercises, include moderate intensity for 40 min, three times a week.

We explained the participants how to perform the exercises, according to an instruction manual for the exercise regimen. Participants were instructed that the exercises would be effective only if they reached 40%-60% of the heart rate reserve, as determined by the Karvonen method, or 13-14 on the RPE.

Exercise education:

Weekly telephone or mobile application "LINE" consultations concerning exercise.we discussed whether participants' exercise fulfilled the prescribed intensity, duration, frequency and whether the participants experienced any adverse effects.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Taipei Veterans General Hospital, Taiwan

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Hui-Mei Chen, PhD

Role: STUDY_CHAIR

National Taipei University of Nursing and Health Sciences, Taipei, Taiwan

Locations

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Taipei Veterans General Hospital

Taipei County, , Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Pei-Shan Ho, BSN

Role: CONTACT

886-933937197

Hui-Mei Chen, PhD

Role: CONTACT

886-939654302

Facility Contacts

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Taipei Veterans General Hospital

Role: primary

+886-2-2875-7808

Other Identifiers

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2020-10-006A

Identifier Type: -

Identifier Source: org_study_id

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