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

2021年12月19日更新者：Taipei Veterans General Hospital, Taiwan

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

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.

調査の概要

状態

募集

条件

胃癌

介入・治療

行動：exercise group

詳細な説明

研究の種類

介入

入学 (予想される)

160

段階

適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

名前：HUI-MEI CHEN, PhD
電話番号：886-939654302
メール：alice@ntunhs.edu.tw

研究連絡先のバックアップ

名前：Pei-Shan Ho, BSN
電話番号：886-933937197
メール：psho@vghtpe.gov.tw

研究場所

台湾
- - Taipei county、台湾、112
    - 募集
    - Taipei Veterans General Hospital
    - コンタクト：
      
      Taipei Veterans General Hospital
      
      電話番号：+886-2-2875-7808

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

20年～90年 (大人、高齢者)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

説明

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.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

主な目的：支持療法
割り当て：ランダム化
介入モデル：並列代入
マスキング：独身

アーム数

武器と介入

参加者グループ / アーム	介入・治療
実験的：exercise group A 12-week regimen of home-based walking exercises, comprising walking at a moderate intensity for 40 min, three times a Week.	行動：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.
介入なし：usual-care group These participants follows the standard post-surgery follow-up consisting of counseling by dietitians, nurses and doctors.

参加者グループ / アーム

介入・治療

実験的：exercise group

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

行動：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.

介入なし：usual-care group

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

この研究は何を測定していますか？

主要な結果の測定

結果測定	メジャーの説明	時間枠
Quality of Life (EORTC QLQ-C30 ) 時間枠：baseline (one week 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.	baseline (one week after recruited)
Quality of Life (EORTC QLQ-C30 ) 時間枠：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.	1st month after recruited
Quality of Life (EORTC QLQ-C30) 時間枠：2nd 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.	2nd month after recruited
Quality of Life (EORTC QLQ-C30) 時間枠：3rd 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.	3rd month after recruited
Quality of Life (EORTC QLQ-C30) 時間枠：6th 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.	6th month after recruited
Quality of Life (EORTC QLQ-C30) 時間枠：12th 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.	12th month after recruited
Quality of Life (EORTC QLQ-C30) 時間枠：24th 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.	24th month after recruited
Quality of Life (EORTC QLQ-C30) 時間枠：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.	36th month after recruited
Quality of Life (EORTC QLQ-STO22) 時間枠：baseline (one week 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.	baseline (one week after recruited)
Quality of Life (EORTC QLQ-STO22) 時間枠：1st 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.	1st month after recruited
Quality of Life (EORTC QLQ-STO22) 時間枠：2nd 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.	2nd month after recruited
Quality of Life (EORTC QLQ-STO22) 時間枠：3rd 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.	3rd month after recruited
Quality of Life (EORTC QLQ-STO22) 時間枠：6th 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.	6th month after recruited
Quality of Life (EORTC QLQ-STO22) 時間枠：12th 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.	12th month after recruited
Quality of Life (EORTC QLQ-STO22) 時間枠：24th 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.	24th month after recruited
Quality of Life (EORTC QLQ-STO22) 時間枠：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.	36th month after recruited

二次結果の測定

結果測定	メジャーの説明	時間枠
fatigue(Brief Fatigue Inventory-Taiwan , BFI-T) 時間枠：baseline (one week after recruited)	The scale is measured by the respondent self-assessed the frequency of various problems with activities of daily living in 24 hours. BFI-T has 9 questions in total； it is a self-reported 11-Point Likert Scale. Retest reliability was 0.89-0.97.	baseline (one week after recruited)
fatigue(Brief Fatigue Inventory-Taiwan , BFI-T) 時間枠：1st month after recruited	The scale is measured by the respondent self-assessed the frequency of various problems with activities of daily living in 24 hours. BFI-T has 9 questions in total；it is a self-reported 11-Point Likert Scale. Retest reliability was 0.89-0.97.	1st month after recruited
fatigue(Brief Fatigue Inventory-Taiwan , BFI-T) 時間枠：2nd month after recruited	The scale is measured by the respondent self-assessed the frequency of various problems with activities of daily living in 24 hours. BFI-T has 9 questions in total；it is a self-reported 11-Point Likert Scale. Retest reliability was 0.89-0.97.	2nd month after recruited
fatigue(Brief Fatigue Inventory-Taiwan , BFI-T) 時間枠：3rd month after recruited	The scale is measured by the respondent self-assessed the frequency of various problems with activities of daily living in 24 hours. BFI-T has 9 questions in total； it is a self-reported 11-Point Likert Scale. Retest reliability was 0.89-0.97.	3rd month after recruited
fatigue(Brief Fatigue Inventory-Taiwan , BFI-T) 時間枠：6th month after recruited	The scale is measured by the respondent self-assessed the frequency of various problems with activities of daily living in 24 hours. BFI-T has 9 questions in total； it is a self-reported 11-Point Likert Scale. Retest reliability was 0.89-0.97.	6th month after recruited
fatigue(Brief Fatigue Inventory-Taiwan , BFI-T) 時間枠：12th month after recruited	The scale is measured by the respondent self-assessed the frequency of various problems with activities of daily living in 24 hours. BFI-T has 9 questions in total； it is a self-reported 11-Point Likert Scale. Retest reliability was 0.89-0.97.	12th month after recruited
fatigue(Brief Fatigue Inventory-Taiwan , BFI-T) 時間枠：24th month after recruited	The scale is measured by the respondent self-assessed the frequency of various problems with activities of daily living in 24 hours. BFI-T has 9 questions in total； it is a self-reported 11-Point Likert Scale. Retest reliability was 0.89-0.97.	24th month after recruited
fatigue(Brief Fatigue Inventory-Taiwan , BFI-T) 時間枠：36th month after recruited	The scale is measured by the respondent self-assessed the frequency of various problems with activities of daily living in 24 hours. BFI-T has 9 questions in total； it is a self-reported 11-Point Likert Scale. Retest reliability was 0.89-0.97.	36th month after recruited
Emotional distress( Hospital Anxiety and Depression Scale, HADS) 時間枠：baseline (one week after recruited)	Emotional distress including anxiety and depression (Hospital Anxiety and Depression Scale). The Hospital Anxiety and Depression Scale include anxiety and depression subscales, a total of 7 questions, each subscale is a four-point scoring method, 0 point for "not at all", 3 points for "always do", each subscale scores is between 0 and 21, that a score of 7 or less for non-cases, scores of 8-10 for doubtful cases and scores of 11 or more for definite cases.	baseline (one week after recruited)
Emotional distress( Hospital Anxiety and Depression Scale, HADS) 時間枠：1st month after recruited	Emotional distress including anxiety and depression (Hospital Anxiety and Depression Scale). The Hospital Anxiety and Depression Scale include anxiety and depression subscales, a total of 7 questions, each subscale is a four-point scoring method, 0 point for "not at all", 3 points for "always do", each subscale scores is between 0 and 21, that a score of 7 or less for non-cases, scores of 8-10 for doubtful cases and scores of 11 or more for definite cases.	1st month after recruited
Emotional distress( Hospital Anxiety and Depression Scale, HADS) 時間枠：2nd month after recruited	Emotional distress including anxiety and depression (Hospital Anxiety and Depression Scale). The Hospital Anxiety and Depression Scale include anxiety and depression subscales, a total of 7 questions, each subscale is a four-point scoring method, 0 point for "not at all", 3 points for "always do", each subscale scores is between 0 and 21, that a score of 7 or less for non-cases, scores of 8-10 for doubtful cases and scores of 11 or more for definite cases.	2nd month after recruited
Emotional distress( Hospital Anxiety and Depression Scale, HADS) 時間枠：3rd month after recruited	Emotional distress including anxiety and depression (Hospital Anxiety and Depression Scale). The Hospital Anxiety and Depression Scale include anxiety and depression subscales, a total of 7 questions, each subscale is a four-point scoring method, 0 point for "not at all", 3 points for "always do", each subscale scores is between 0 and 21, that a score of 7 or less for non-cases, scores of 8-10 for doubtful cases and scores of 11 or more for definite cases.	3rd month after recruited
Emotional distress( Hospital Anxiety and Depression Scale, HADS) 時間枠：6th month after recruited	Emotional distress including anxiety and depression (Hospital Anxiety and Depression Scale). The Hospital Anxiety and Depression Scale include anxiety and depression subscales, a total of 7 questions, each subscale is a four-point scoring method, 0 point for "not at all", 3 points for "always do", each subscale scores is between 0 and 21, that a score of 7 or less for non-cases, scores of 8-10 for doubtful cases and scores of 11 or more for definite cases.	6th month after recruited
Emotional distress( Hospital Anxiety and Depression Scale, HADS) 時間枠：12th month after recruited	Emotional distress including anxiety and depression (Hospital Anxiety and Depression Scale). The Hospital Anxiety and Depression Scale include anxiety and depression subscales, a total of 7 questions, each subscale is a four-point scoring method, 0 point for "not at all", 3 points for "always do", each subscale scores is between 0 and 21, that a score of 7 or less for non-cases, scores of 8-10 for doubtful cases and scores of 11 or more for definite cases.	12th month after recruited
Emotional distress( Hospital Anxiety and Depression Scale, HADS) 時間枠：24th month after recruited	Emotional distress including anxiety and depression (Hospital Anxiety and Depression Scale). The Hospital Anxiety and Depression Scale include anxiety and depression subscales, a total of 7 questions, each subscale is a four-point scoring method, 0 point for "not at all", 3 points for "always do", each subscale scores is between 0 and 21, that a score of 7 or less for non-cases, scores of 8-10 for doubtful cases and scores of 11 or more for definite cases.	24th month after recruited
Emotional distress( Hospital Anxiety and Depression Scale, HADS) 時間枠：36th month after recruited	Emotional distress including anxiety and depression (Hospital Anxiety and Depression Scale). The Hospital Anxiety and Depression Scale include anxiety and depression subscales, a total of 7 questions, each subscale is a four-point scoring method, 0 point for "not at all", 3 points for "always do", each subscale scores is between 0 and 21, that a score of 7 or less for non-cases, scores of 8-10 for doubtful cases and scores of 11 or more for definite cases.	36th month after recruited
sleep quality(Pittsburgh Sleep Quality Index and using Actigraph) 時間枠：baseline (one week after recruited)	The Pittsburgh Sleep Quality Index (PSQI) contains 19 self-rated questions and 5 questions rated by the bed partner or roommate (if one is available). Each item is weighted on a 0-3 interval scale. The global PSQI score is then calculated by totaling the seven component scores, providing an overall score ranging from 0 to 21, where lower scores denote a healthier sleep quality. Actigraph is the gold standard for evaluating sleep disorders. As the name suggests, it is an electrophysiological recording of multiple parameters, including total sleep time(TST), sleep efficiency(SE), and sleep onset latency(SOL) which help to score various sleep stages.	baseline (one week after recruited)
sleep quality(Pittsburgh Sleep Quality Index and using Actigraph) 時間枠：3rd month after recruited	The Pittsburgh Sleep Quality Index (PSQI) contains 19 self-rated questions and 5 questions rated by the bed partner or roommate (if one is available). Each item is weighted on a 0-3 interval scale. The global PSQI score is then calculated by totaling the seven component scores, providing an overall score ranging from 0 to 21, where lower scores denote a healthier sleep quality. Actigraph is the gold standard for evaluating sleep disorders. As the name suggests, it is an electrophysiological recording of multiple parameters, including total sleep time(TST), sleep efficiency(SE), and sleep onset latency(SOL) which help to score various sleep stages.	3rd month after recruited
sleep quality(Pittsburgh Sleep Quality Index and using Actigraph) 時間枠：6th month after recruited	The Pittsburgh Sleep Quality Index (PSQI) contains 19 self-rated questions and 5 questions rated by the bed partner or roommate (if one is available). Each item is weighted on a 0-3 interval scale. The global PSQI score is then calculated by totaling the seven component scores, providing an overall score ranging from 0 to 21, where lower scores denote a healthier sleep quality. Actigraph is the gold standard for evaluating sleep disorders. As the name suggests, it is an electrophysiological recording of multiple parameters, including total sleep time(TST), sleep efficiency(SE), and sleep onset latency(SOL) which help to score various sleep stages.	6th month after recruited
sleep quality(Pittsburgh Sleep Quality Index and using Actigraph) 時間枠：12th month after recruited	The Pittsburgh Sleep Quality Index (PSQI) contains 19 self-rated questions and 5 questions rated by the bed partner or roommate (if one is available). Each item is weighted on a 0-3 interval scale. The global PSQI score is then calculated by totaling the seven component scores, providing an overall score ranging from 0 to 21, where lower scores denote a healthier sleep quality. Actigraph is the gold standard for evaluating sleep disorders. As the name suggests, it is an electrophysiological recording of multiple parameters, including total sleep time(TST), sleep efficiency(SE), and sleep onset latency(SOL) which help to score various sleep stages.	12th month after recruited
sleep quality(Pittsburgh Sleep Quality Index and using Actigraph) 時間枠：24th month after recruited	The Pittsburgh Sleep Quality Index (PSQI) contains 19 self-rated questions and 5 questions rated by the bed partner or roommate (if one is available). Each item is weighted on a 0-3 interval scale. The global PSQI score is then calculated by totaling the seven component scores, providing an overall score ranging from 0 to 21, where lower scores denote a healthier sleep quality. Actigraph is the gold standard for evaluating sleep disorders. As the name suggests, it is an electrophysiological recording of multiple parameters, including total sleep time(TST), sleep efficiency(SE), and sleep onset latency(SOL) which help to score various sleep stages.	24th month after recruited
sleep quality(Pittsburgh Sleep Quality Index and using Actigraph) 時間枠：36th month after recruited	The Pittsburgh Sleep Quality Index (PSQI) contains 19 self-rated questions and 5 questions rated by the bed partner or roommate (if one is available). Each item is weighted on a 0-3 interval scale. The global PSQI score is then calculated by totaling the seven component scores, providing an overall score ranging from 0 to 21, where lower scores denote a healthier sleep quality. Actigraph is the gold standard for evaluating sleep disorders. As the name suggests, it is an electrophysiological recording of multiple parameters, including total sleep time(TST), sleep efficiency(SE), and sleep onset latency(SOL) which help to score various sleep stages.	36th month after recruited
Circadian rhythms(using Actigraph) 時間枠：baseline (one week after recruited)	Circadian rhythms including 24-h autocorrelation coefficient (r24) and in bed less than out of bed dichotomy index (I<O) collection from actigraphy.	baseline (one week after recruited)
Circadian rhythms(using Actigraph) 時間枠：3rd month after recruited	Circadian rhythms including 24-h autocorrelation coefficient (r24) and in bed less than out of bed dichotomy index (I<O) collection from actigraphy.	3rd month after recruited
Circadian rhythms(using Actigraph) 時間枠：6th month after recruited	Circadian rhythms including 24-h autocorrelation coefficient (r24) and in bed less than out of bed dichotomy index (I<O) collection from actigraphy.	6th month after recruited
Circadian rhythms(using Actigraph) 時間枠：12th month after recruited	Circadian rhythms including 24-h autocorrelation coefficient (r24) and in bed less than out of bed dichotomy index (I<O) collection from actigraphy.	12th month after recruited
Circadian rhythms(using Actigraph) 時間枠：24th month after recruited	Circadian rhythms including 24-h autocorrelation coefficient (r24) and in bed less than out of bed dichotomy index (I<O) collection from actigraphy.	24th month after recruited
Circadian rhythms(using Actigraph) 時間枠：36th month after recruited	Circadian rhythms including 24-h autocorrelation coefficient (r24) and in bed less than out of bed dichotomy index (I<O) collection from actigraphy.	36th month after recruited

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Taipei Veterans General Hospital, Taiwan

捜査官

スタディチェア：Hui-Mei Chen, PhD、National Taipei University of Nursing and Health Sciences, Taipei, Taiwan

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2020年11月10日

一次修了 (予想される)

2024年10月31日

研究の完了 (予想される)

2025年10月31日

試験登録日

最初に提出

2020年9月21日

QC基準を満たした最初の提出物

2020年10月13日

最初の投稿 (実際)

2020年10月19日

学習記録の更新

投稿された最後の更新 (実際)

2021年12月21日

QC基準を満たした最後の更新が送信されました

2021年12月19日

最終確認日

2021年12月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

2020-10-006A

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

はい

IPD プランの説明

Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).

IPD 共有時間枠

Beginning 12 months following article publication

IPD 共有アクセス基準

Researchers who provide a methodologically sound proposal and receive the authors consent.

IPD 共有サポート情報タイプ

STUDY_PROTOCOL

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

胃癌の臨床試験

Novartis Pharmaceuticals

終了しました

進行性固形腫瘍の成人患者におけるTNO155の用量設定研究

メラノーマ | 高度なEGFR変異体非小さな細胞肺cancer（NSCLC） | KRAS G12変異NSCLC | 食道扁平上皮がん（SCC） | ヘッド/ネックSCC | 進行した胃腸間質腫瘍（GIST） | 進行したNRAS/BRAFT WT皮膚黒色腫

アメリカ, 台湾, オランダ, カナダ, スペイン, シンガポール, イタリア, 日本, 韓国
Jonsson Comprehensive Cancer Center
National Cancer Institute (NCI); Highlight Therapeutics

積極的、募集していない

切除可能な軟部肉腫の治療のための手術前のニボルマブと BO-112

平滑筋肉腫 | 悪性末梢神経鞘腫瘍 | 滑膜肉腫 | 未分化多形肉腫 | 骨の未分化高悪性度多形肉腫 | 粘液線維肉腫 | II期の体幹および四肢の軟部肉腫 AJCC v8 | III期の体幹および四肢の軟部肉腫 AJCC v8 | IIIA 期の体幹および四肢の軟部肉腫 AJCC v8 | IIIB 期の体幹および四肢の軟部肉腫 AJCC v8 | 切除可能な軟部肉腫 | 多形性横紋筋肉腫 | 切除可能な脱分化型脂肪肉腫 | 切除可能な未分化多形肉腫 | 軟部組織線維肉腫 | 紡錘細胞肉腫 | ステージ I 後腹膜肉腫 AJCC (American Joint Committee on Cancer) v8 | 体幹および四肢の I 期軟部肉腫 AJCC v8 | ステージ... およびその他の条件

アメリカ

exercise groupの臨床試験

National Taiwan Normal University

完了

物理的に活動的な成人の代謝の健康に対する断食と連邦政府の運動の影響

血圧 | インスリン感受性 | 脂質プロファイル | 基質の酸化 | グルコースレベル

台湾
University of Erlangen-Nürnberg Medical School
Klinikum Nürnberg

完了

レジスタンスエクササイズ、筋肉量、筋力、体組成

肥満 | サルコペニア

ドイツ
Riphah International University

まだ募集していません

カルテンボーンとマリガンの動員による、足底筋膜炎における固有の足強化による動員

足底筋膜炎 | かかとの痛み症候群

パキスタン
Riphah International University

まだ募集していません

腰椎脊髄狭窄における運河拡大運動とともに、メイトランドとマリガンの脊椎動員の影響

腰痛 | 脊柱管狭窄症

パキスタン
University of Toronto
University Health Network, Toronto; University of Western Ontario, Canada; Institute for Clinical... と他の協力者

完了

グループ、タスク指向の地域ベースの運動プログラムは、脳卒中患者の日常機能を改善しますか?

脳卒中 | 日常生活の行動 | 移動制限 | バランス

カナダ
Cardinal Tien Hospital

完了

血液透析中の透析内演習

腎不全、慢性
Mansoura University

まだ募集していません

オケタニ式乳房マッサージが母乳育児促進に及ぼす効果 (OKETANI-BF)

母乳育児 | 母乳育児の自己効力感 | オケタニマッサージ | ラッチング

エジプト
Saglik Bilimleri Universitesi

まだ募集していません

リフレクソロジーが月経症候群の症状、痛み、生活の質に及ぼす影響

前後症候群の症状に対するリフレクソロジーの効果
Çankırı Karatekin University

完了

糖尿病における口の乾燥のためのチューインガムの影響

ドライマウス | 糖尿病（DM）

七面鳥
Inonu University

完了

分娩室におけるバースストーリー作成が分娩恐怖に及ぼす影響

誕生

トルコ（Türkiye）

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

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

調査の概要

状態

条件

介入・治療

詳細な説明

研究の種類

入学 (予想される)

段階

連絡先と場所

研究連絡先

研究連絡先のバックアップ

研究場所

参加基準

適格基準

就学可能な年齢

健康ボランティアの受け入れ

受講資格のある性別

説明

研究計画

研究はどのように設計されていますか？

デザインの詳細

アーム数

武器と介入

参加者グループ / アーム

介入・治療

この研究は何を測定していますか？

主要な結果の測定

結果測定

メジャーの説明

時間枠

二次結果の測定

結果測定

メジャーの説明

時間枠

協力者と研究者

スポンサー

捜査官

研究記録日

主要日程の研究

研究開始 (実際)

一次修了 (予想される)

研究の完了 (予想される)

試験登録日

最初に提出

QC基準を満たした最初の提出物

最初の投稿 (実際)

学習記録の更新

投稿された最後の更新 (実際)

QC基準を満たした最後の更新が送信されました

最終確認日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

IPD プランの説明

IPD 共有時間枠

IPD 共有アクセス基準

IPD 共有サポート情報タイプ

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

米国FDA規制機器製品の研究

胃癌の臨床試験

exercise groupの臨床試験

類似の治験を検索

スポンサーと協力者

医学的状態

薬物療法

CROs by country

CROs in Zimbabwe

条件

まれな病気

薬物療法

ダイエットサプリメント

スポンサー/協力者

場所