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

19 grudnia 2021 zaktualizowane przez: 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.

Przegląd badań

Status

Rekrutacyjny

Warunki

Rak żołądka

Interwencja / Leczenie

Behawioralne: exercise group

Szczegółowy opis

Typ studiów

Interwencyjne

Zapisy (Oczekiwany)

160

Faza

Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

Nazwa: HUI-MEI CHEN, PhD
Numer telefonu: 886-939654302
E-mail: alice@ntunhs.edu.tw

Kopia zapasowa kontaktu do badania

Nazwa: Pei-Shan Ho, BSN
Numer telefonu: 886-933937197
E-mail: psho@vghtpe.gov.tw

Lokalizacje studiów

Tajwan
- - Taipei county, Tajwan, 112
    - Rekrutacyjny
    - Taipei Veterans General Hospital
    - Kontakt:
      
      Taipei Veterans General Hospital
      
      Numer telefonu: +886-2-2875-7808

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

20 lat do 90 lat (Dorosły, Starszy dorosły)

Akceptuje zdrowych ochotników

Nie

Płeć kwalifikująca się do nauki

Wszystko

Opis

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.

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

Główny cel: Leczenie podtrzymujące
Przydział: Randomizowane
Model interwencyjny: Przydział równoległy
Maskowanie: Pojedynczy

Liczba ramion

Broń i interwencje

Grupa uczestników / Arm	Interwencja / Leczenie
Eksperymentalny: exercise group A 12-week regimen of home-based walking exercises, comprising walking at a moderate intensity for 40 min, three times a Week.	Behawioralne: 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.
Brak interwencji: usual-care group These participants follows the standard post-surgery follow-up consisting of counseling by dietitians, nurses and doctors.

Grupa uczestników / Arm

Interwencja / Leczenie

Eksperymentalny: exercise group

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

Behawioralne: 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.

Brak interwencji: usual-care group

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

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku	Opis środka	Ramy czasowe
Quality of Life (EORTC QLQ-C30 ) Ramy czasowe: 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 ) Ramy czasowe: 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) Ramy czasowe: 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) Ramy czasowe: 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) Ramy czasowe: 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) Ramy czasowe: 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) Ramy czasowe: 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) Ramy czasowe: 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) Ramy czasowe: 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) Ramy czasowe: 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) Ramy czasowe: 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) Ramy czasowe: 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) Ramy czasowe: 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) Ramy czasowe: 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) Ramy czasowe: 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) Ramy czasowe: 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

Miary wyników drugorzędnych

Miara wyniku	Opis środka	Ramy czasowe
fatigue(Brief Fatigue Inventory-Taiwan , BFI-T) Ramy czasowe: 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) Ramy czasowe: 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) Ramy czasowe: 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) Ramy czasowe: 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) Ramy czasowe: 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) Ramy czasowe: 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) Ramy czasowe: 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) Ramy czasowe: 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) Ramy czasowe: 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) Ramy czasowe: 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) Ramy czasowe: 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) Ramy czasowe: 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) Ramy czasowe: 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) Ramy czasowe: 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) Ramy czasowe: 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) Ramy czasowe: 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) Ramy czasowe: 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) Ramy czasowe: 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) Ramy czasowe: 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) Ramy czasowe: 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) Ramy czasowe: 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) Ramy czasowe: 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) Ramy czasowe: 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) Ramy czasowe: 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) Ramy czasowe: 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) Ramy czasowe: 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) Ramy czasowe: 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) Ramy czasowe: 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

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Taipei Veterans General Hospital, Taiwan

Śledczy

Krzesło do nauki: Hui-Mei Chen, PhD, National Taipei University of Nursing and Health Sciences, Taipei, Taiwan

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

10 listopada 2020

Zakończenie podstawowe (Oczekiwany)

31 października 2024

Ukończenie studiów (Oczekiwany)

31 października 2025

Daty rejestracji na studia

Pierwszy przesłany

21 września 2020

Pierwszy przesłany, który spełnia kryteria kontroli jakości

13 października 2020

Pierwszy wysłany (Rzeczywisty)

19 października 2020

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

21 grudnia 2021

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

19 grudnia 2021

Ostatnia weryfikacja

1 grudnia 2021

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

2020-10-006A

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

TAK

Opis planu IPD

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

Ramy czasowe udostępniania IPD

Beginning 12 months following article publication

Kryteria dostępu do udostępniania IPD

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

Typ informacji pomocniczych dotyczących udostępniania IPD

PROTOKÓŁ BADANIA

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

Badania kliniczne na Rak żołądka

Jonsson Comprehensive Cancer Center
National Cancer Institute (NCI)

Aktywny, nie rekrutujący

Stereotaktyczna radioterapia ciała w leczeniu pacjentów z rakiem prostaty wysokiego ryzyka poddawanych zabiegom chirurgicznym

Gruczolakorak gruczołu krokowego III stopnia AJCC v7 | Gruczolakorak gruczołu krokowego II stopnia AJCC v7 | Stopień I gruczolakoraka gruczołu krokowego American Joint Committee on Cancer (AJCC) v7

Stany Zjednoczone
Emory University
National Cancer Institute (NCI)

Wycofane

Radiochirurgia stereotaktyczna z użyciem abemacyklibu, rybocyklibu lub palbocyklibu w leczeniu pacjentów z rakiem piersi z dodatnim receptorem hormonalnym i przerzutami do mózgu

Prognostyczny rak piersi IV stopnia AJCC v8 | Przerzutowy nowotwór złośliwy w mózgu | Przerzutowy rak piersi | Anatomiczny IV stopień raka piersi American Joint Committee on Cancer (AJCC) v8
Jonsson Comprehensive Cancer Center

Zakończony

Wpływ inhibitorów sygnalizacji receptora androgenowego na obrazowanie PET/CT 68Ga-PSMA-11 u pacjentów z opornym na kastrację rakiem prostaty

Rak prostaty oporny na kastrację | Przerzutowy rak prostaty | Stadium IVA raka prostaty AJCC v8 | Rak prostaty w stadium IVB AJCC v8 | Rak prostaty w stadium IV American Joint Committee on Cancer (AJCC) v8

Stany Zjednoczone
Jonsson Comprehensive Cancer Center

Zakończony

68Ga-PSMA-11 PET/CT do diagnostyki przerzutów do kości u pacjentów z rakiem prostaty i progresji biochemicznej podczas terapii deprywacji androgenów

Biochemicznie nawracający rak prostaty | Przerzutowy rak prostaty | Nowotwór złośliwy z przerzutami w kości | Stadium IVA raka prostaty AJCC v8 | Rak prostaty w stadium IVB AJCC v8 | Rak prostaty w stadium IV American Joint Committee on Cancer (AJCC) v8

Stany Zjednoczone
Jonsson Comprehensive Cancer Center
Eli Lilly and Company; Genentech, Inc.

Rekrutacyjny

Necytumumab i trastuzumab w skojarzeniu z ozymertynibem w leczeniu opornego na leczenie receptora naskórkowego czynnika wzrostu (EGFR) w stadium IV z mutacją niedrobnokomórkowego raka płuca

Niedrobnokomórkowy rak płuc z przerzutami | Oporny na leczenie niedrobnokomórkowy rak płuc | Rak płuca w stadium IV American Joint Committee on Cancer (AJCC) v8 | Rak płuc w stadium IVA AJCC v8 | Rak płuc w stadium IVB AJCC v8

Stany Zjednoczone
Jonsson Comprehensive Cancer Center

Rekrutacyjny

Biopsje sterowane obrazem w celu identyfikacji mechanizmów oporności u pacjentów z opornym na kastrację rakiem gruczołu krokowego z przerzutami, leczonych radioligandem 177Lu-PSMA

Rak prostaty oporny na kastrację | Przerzutowy rak prostaty | Stadium IVA raka prostaty AJCC v8 | Rak prostaty w stadium IVB AJCC v8 | Rak prostaty w stadium IV American Joint Committee on Cancer (AJCC) v8

Stany Zjednoczone
NRG Oncology
National Cancer Institute (NCI)

Aktywny, nie rekrutujący

Testowanie, czy leczenie przerzutów raka piersi za pomocą operacji lub promieniowania w dużych dawkach poprawia przeżycie

Anatomiczny rak piersi IV stadium AJCC v8 | Prognostyczny rak piersi IV stopnia AJCC v8 | Nowotwór złośliwy z przerzutami w kości | Przerzutowy nowotwór złośliwy w węzłach chłonnych | Przerzutowy nowotwór złośliwy w wątrobie | Przerzutowy rak piersi | Przerzutowy nowotwór złośliwy w płucach | Nowotwór... i inne warunki

Stany Zjednoczone, Kanada, Arabia Saudyjska, Republika Korei
National Cancer Institute (NCI)

Zakończony

Navitoclax i Vistusertib w leczeniu pacjentów z nawrotowym rakiem drobnokomórkowym płuca i innymi guzami litymi

Oporny na leczenie złośliwy nowotwór lity | Nawracający złośliwy nowotwór lity | Przerzutowy złośliwy nowotwór lity | Nieoperacyjny lity nowotwór | Nawracający rak drobnokomórkowy płuca | Stopień IIIA Rak drobnokomórkowy płuca AJCC v7 | Etap IIIB Rak drobnokomórkowy płuca AJCC v7 | Rak drobnokomórkowy... i inne warunki

Stany Zjednoczone
Jonsson Comprehensive Cancer Center
BeiGene; Driven To Cure

Wycofane

Pamiparib i temozolomid w leczeniu dziedzicznej mięśniakowatości gładkokomórkowej i raka nerki

Przerzutowy rak nerkowokomórkowy | Rak nerkowokomórkowy IV stopnia AJCC v8 | Rak brodawkowaty nerki | Zbieranie raka przewodów | Nieoperacyjny rak nerki | Dziedziczna leiomyomatoza i rak nerkowokomórkowy | Jasnokomórkowy brodawkowaty nowotwór nerki | Dziedziczny rak brodawkowaty nerki | Niesklasyfikowany... i inne warunki

Stany Zjednoczone
Jonsson Comprehensive Cancer Center
AstraZeneca

Zakończony

Stereotaktyczna radioterapia ciała i durwalumab z tremelimumabem lub bez przed zabiegiem chirurgicznym w leczeniu uczestników zakażonych wirusem brodawczaka ludzkiego z rakiem płaskonabłonkowym jamy ustnej i gardła

Rak płaskonabłonkowy jamy ustnej i gardła | Stopień kliniczny III zależny od HPV (p16-dodatni) rak jamy ustnej i gardła AJCC v8 | Stopień kliniczny II, w którym pośredniczy HPV (p16-dodatni) rak jamy ustnej i gardła AJCC v8 | Patologiczny etap I, w którym pośredniczy HPV (p16-dodatni) rak jamy... i inne warunki

Stany Zjednoczone

Badania kliniczne na exercise group

Karadeniz Technical University

Zakończony

Efekty terapii Robotic Cat i Betta Fish u pacjentów hemodializowanych (Pet Therapy)

Hemodializa | Samotność | Szczęście | Dostosowanie | Terapia wspomagana przez zwierzęta | Objaw

Indyk
Children's National Research Institute

Zakończony

Korzystanie z fotelika samochodowego dla niemowląt

Szkolenie w zakresie bezpieczeństwa fotelików samochodowych dla dzieci

Stany Zjednoczone
The Hong Kong Polytechnic University

Zakończony

Wpływ przypomnienia z aplikacji do przesyłania wiadomości na zgodność ćwiczenia w czasie zerowym (ZTEx)

Bezsenność, podstawowy

Hongkong
Aarhus University Hospital
University of Aarhus

Zakończony

ConquerFear-Group: Psychologiczna interwencja w obawie przed nawrotem raka

Kobieta z rakiem piersi | Strach przed nawrotem raka

Dania
Arizona Oncology Services

Nieznany

Wykorzystanie organicznego germanu lub placebo w zapobieganiu zmęczeniu wywołanemu promieniowaniem

Zlokalizowany rak piersi | Zlokalizowany rak prostaty | Pacjenci otrzymujący radioterapię wiązką zewnętrzną

Stany Zjednoczone
KK Women's and Children's Hospital
Singapore Institute for Clinical Sciences; Duke-NUS Graduate Medical School

Rekrutacyjny

Zintegrowane badanie nadzoru postnatalnego motywowanego hiperglikemią (I-HIPS) (I-HIPS)

Zaburzenia metabolizmu glukozy | Cukrzyca ciężarnych | Choroba metaboliczna

Singapur
Universitat Jaume I

Zakończony

Wykonalność grupowego protokołu transdiagnostycznego CBT dla zaburzeń emocjonalnych

Zaburzenia depresyjne | Zaburzenia lękowe

Hiszpania
Seyda Ersahan, DDS, PhD

Aktywny, nie rekrutujący

Ocena wpływu leukocytów i fibryny bogatopłytkowej na gojenie po operacji okołokorzeniowej

Wierzchołkowe zapalenie przyzębia | Uszkodzenie okołowierzchołkowe

Indyk
Boston Medical Center
Boston University; National Institute of Diabetes and Digestive and Kidney Diseases... i inni współpracownicy

Zakończony

Kobiety pod kontrolą: wirtualne światowe badanie samokontroli cukrzycy

Cukrzyca

Stany Zjednoczone
Universidad Católica San Antonio de Murcia

Zakończony

Noninvasive Treatment of Upper Trapezius Active Trigger Points in College Students With Neck Pain

Ból szyi | Ból punktu spustowego, mięśniowo-powięziowy

Hiszpania

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

Przegląd badań

Status

Warunki

Interwencja / Leczenie

Szczegółowy opis

Typ studiów

Zapisy (Oczekiwany)

Faza

Kontakty i lokalizacje

Kontakt w sprawie studiów

Kopia zapasowa kontaktu do badania

Lokalizacje studiów

Kryteria uczestnictwa

Kryteria kwalifikacji

Wiek uprawniający do nauki

Akceptuje zdrowych ochotników

Płeć kwalifikująca się do nauki

Opis

Plan studiów

Jak projektuje się badanie?

Szczegóły projektu

Liczba ramion

Broń i interwencje

Grupa uczestników / Arm

Interwencja / Leczenie

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku

Opis środka

Ramy czasowe

Miary wyników drugorzędnych

Miara wyniku

Opis środka

Ramy czasowe

Współpracownicy i badacze

Sponsor

Śledczy

Daty zapisu na studia

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

Zakończenie podstawowe (Oczekiwany)

Ukończenie studiów (Oczekiwany)

Daty rejestracji na studia

Pierwszy przesłany

Pierwszy przesłany, który spełnia kryteria kontroli jakości

Pierwszy wysłany (Rzeczywisty)

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

Ostatnia weryfikacja

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

Opis planu IPD

Ramy czasowe udostępniania IPD

Kryteria dostępu do udostępniania IPD

Typ informacji pomocniczych dotyczących udostępniania IPD

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Bada produkt urządzenia regulowany przez amerykańską FDA

Badania kliniczne na Rak żołądka

Badania kliniczne na exercise group

Wyszukaj podobne próby

Sponsorzy i współpracownicy

Warunki medyczne

Interwencje lekowe

CROs by country

CROs in Mongolia

Warunki

Rzadkie choroby

Interwencje lekowe

Suplementy diety

Sponsor / Współpracownicy

Lokalizacje