Denne side blev automatisk oversat, og nøjagtigheden af oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

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

19. december 2021 opdateret af: 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.

Studieoversigt

Status

Rekruttering

Betingelser

Mavekræft

Intervention / Behandling

Adfærdsmæssigt: exercise group

Detaljeret beskrivelse

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

160

Fase

Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Navn: HUI-MEI CHEN, PhD
Telefonnummer: 886-939654302
E-mail: alice@ntunhs.edu.tw

Undersøgelse Kontakt Backup

Navn: Pei-Shan Ho, BSN
Telefonnummer: 886-933937197
E-mail: psho@vghtpe.gov.tw

Studiesteder

Taiwan
- - Taipei county, Taiwan, 112
    - Rekruttering
    - Taipei Veterans General Hospital
    - Kontakt:
      
      Taipei Veterans General Hospital
      
      Telefonnummer: +886-2-2875-7808

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

20 år til 90 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Primært formål: Støttende pleje
Tildeling: Randomiseret
Interventionel model: Parallel tildeling
Maskning: Enkelt

Antal våben

Våben og indgreb

Deltagergruppe / Arm	Intervention / Behandling
Eksperimentel: exercise group A 12-week regimen of home-based walking exercises, comprising walking at a moderate intensity for 40 min, three times a Week.	Adfærdsmæssigt: 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.
Ingen indgriben: usual-care group These participants follows the standard post-surgery follow-up consisting of counseling by dietitians, nurses and doctors.

Deltagergruppe / Arm

Intervention / Behandling

Eksperimentel: exercise group

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

Adfærdsmæssigt: 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.

Ingen indgriben: usual-care group

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

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål	Foranstaltningsbeskrivelse	Tidsramme
Quality of Life (EORTC QLQ-C30 ) Tidsramme: 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 ) Tidsramme: 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) Tidsramme: 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) Tidsramme: 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) Tidsramme: 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) Tidsramme: 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) Tidsramme: 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) Tidsramme: 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) Tidsramme: 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) Tidsramme: 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) Tidsramme: 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) Tidsramme: 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) Tidsramme: 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) Tidsramme: 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) Tidsramme: 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) Tidsramme: 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

Sekundære resultatmål

Resultatmål	Foranstaltningsbeskrivelse	Tidsramme
fatigue(Brief Fatigue Inventory-Taiwan , BFI-T) Tidsramme: 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) Tidsramme: 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) Tidsramme: 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) Tidsramme: 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) Tidsramme: 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) Tidsramme: 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) Tidsramme: 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) Tidsramme: 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) Tidsramme: 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) Tidsramme: 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) Tidsramme: 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) Tidsramme: 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) Tidsramme: 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) Tidsramme: 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) Tidsramme: 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) Tidsramme: 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) Tidsramme: 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) Tidsramme: 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) Tidsramme: 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) Tidsramme: 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) Tidsramme: 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) Tidsramme: 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) Tidsramme: 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) Tidsramme: 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) Tidsramme: 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) Tidsramme: 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) Tidsramme: 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) Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Taipei Veterans General Hospital, Taiwan

Efterforskere

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

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

10. november 2020

Primær færdiggørelse (Forventet)

31. oktober 2024

Studieafslutning (Forventet)

31. oktober 2025

Datoer for studieregistrering

Først indsendt

21. september 2020

Først indsendt, der opfyldte QC-kriterier

13. oktober 2020

Først opslået (Faktiske)

19. oktober 2020

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

21. december 2021

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

19. december 2021

Sidst verificeret

1. december 2021

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

2020-10-006A

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

IPD-planbeskrivelse

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

IPD-delingstidsramme

Beginning 12 months following article publication

IPD-delingsadgangskriterier

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

IPD-deling Understøttende informationstype

STUDY_PROTOCOL

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Mavekræft

Washington University School of Medicine
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Afsluttet

At definere rollen af GLP-1 til forbedring af glukosehomeostase hos mennesker efter gastrisk bypass-kirurgi

Roux-en-Y Gastric Bypass | Bariatrisk kirurgi | Vertikal ærmegatrektomi | Mavebånd | Bypass, Gastric

Forenede Stater
Medtronic - MITG

Afsluttet

Sikkerheds- og effektivitetsundersøgelse af Duet TRS

Roux En Y Gastric Bypass

Forenede Stater
Duomed

Aktiv, ikke rekrutterende

Et observationsregister efter markedet med easyEndoTM Universal Linear Cutting Stapler i laparoskopisk bariatrisk kirurgi (STAP-Delta)

Fedme | Gastrectomi | Roux-en-Y Gastric Bypass | Mini Gastric Bypass

Belgien
Olympus Corporation of the Americas
Unity Health Toronto

Afsluttet

BlackBox-undersøgelsen

Laparoskopisk Roux-en-y Gastric Bypass

Canada
North Dakota State University
National Institutes of Health (NIH)

Afsluttet

Farmakokinetiske egenskaber af sertralin før og efter gastrisk bypass-operation

Roux en Y Gastric Bypass Operation

Forenede Stater
Rijnstate Hospital

Afsluttet

Bariatriske procedurer og ændringer gastrisk passage (BIP)

Roux-en-Y Gastric Bypass | Mavetømning | Bariatrisk kirurgi

Holland
Wageningen University
Rijnstate Hospital

Ukendt

Ændringer i fødevarepræference og responsivitet efter fedmekirurgi (Verrukkelijk)

Roux-en-Y Gastric Bypass

Holland
North Dakota State University
Neuropsychiatric Research Institute, Fargo, North Dakota

Afsluttet

En sammenligning af bupropion med langvarig og forlænget frigivelse efter fedmekirurgi

Roux en Y Gastric Bypass

Forenede Stater
Rijnstate Hospital

Afsluttet

Forsøg med jernabsorption

Bariatrisk kirurgi | Jernoptagelse | Roux- en -y Gastric Bypass

Holland
North Dakota State University
Neuropsychiatric Research Institute, Fargo, North Dakota

Afsluttet

Venlafaxin PK efter bariatrisk kirurgi (VLX)

Sleeve Gastrectomy | Roux en Y Gastric Bypass

Forenede Stater

Kliniske forsøg med exercise group

Centro de Atenção ao Assoalho Pélvico
Indústria Brasileira Equipamentos Médicos - IBRAMED

Rekruttering

Sammenligning af konservative behandlingsmuligheder i håndteringen af erektil dysfunktion

Erektil dysfunktion

Brasilien
Ayşegül İşler Dalgıç
Horizon

Ikke rekrutterer endnu

Metavers-baseret sundt livsprogram for unge (MetaYouth)

Stress, følelsesmæssig | Sundhedsrisikoadfærd | Sundhedsrelateret adfærd | Sund livsstil | Fysisk inaktivitet | Sund ernæring | Indeks for sund kost | Ikke-smitsomme sygdomme

Kalkun
RenJi Hospital

Ikke rekrutterer endnu

En sammenligning af slagvolumenvariation til forudsigelse af væskerespons

Flydende reaktionsevne | Slagvolumen variation | SVV-FloTrac | Thorax elektrisk bioimpedans

Kina
RenJi Hospital

Ikke rekrutterer endnu

En sammenligning af Thoracic Electrical Bioimpedance og FloTrac/Vigileo

Flydende reaktionsevne | Slagvolumen variation | SVV-FloTrac | Thorax elektrisk bioimpedans

Kina
Boston Medical Center
National Institute of Mental Health (NIMH)

Afsluttet

Implementering af en færdighedstræning Evidensbaseret behandling for posttraumatisk stresslidelse i primærpleje (I-STEP)

Post traumatisk stress syndrom

Forenede Stater
Hui-Hsun Chiang

Afsluttet

Effektiviteten af at bruge Jiu-Jitsu til at håndtere medicinsk vold hos sundhedspersonale

Uddannelsesmæssige problemer | Ammende | Vold på arbejdspladsen

Taiwan
University of California, San Francisco
Mount Zion Health Fund; Pritzker Family Foundation; Mental Insight Foundation

Afsluttet

Behandling af svær depression med yoga: et fremtidigt, randomiseret kontrolleret pilotforsøg

Depression, Unipolar

Forenede Stater
Shengjing Hospital

Rekruttering

Prone Positioning CT-scanning og ultralydsvurdering af aksillære lymfeknuder hos patienter med brystkræft Officiel titel: Evaluering af aksillære lymfeknuder ved hjælp af prone positionering computertomografi scanning og ultralyd hos patienter med brystkræft

Brystkræft

Kina
Community Health Center of Franklin County
Massachusetts General Hospital; Just Roots

Ukendt

Im(Beviser) CSA-modellen

Kostændring | Overvægt og fedme | Dårlig ernæring

Forenede Stater
Ottawa Heart Institute Research Corporation

Afsluttet

Integrering af "Ottawa-modellen" for rygestop i primærplejepraksis (RCT-OMSC-PC)

Rygestop

Canada

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

Studieoversigt

Status

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Undersøgelsestype

Tilmelding (Forventet)

Fase

Kontakter og lokationer

Studiekontakt

Undersøgelse Kontakt Backup

Studiesteder

Deltagelseskriterier

Berettigelseskriterier

Aldre berettiget til at studere

Tager imod sunde frivillige

Køn, der er berettiget til at studere

Beskrivelse

Studieplan

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Antal våben

Våben og indgreb

Deltagergruppe / Arm

Intervention / Behandling

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål

Foranstaltningsbeskrivelse

Tidsramme

Sekundære resultatmål

Resultatmål

Foranstaltningsbeskrivelse

Tidsramme

Samarbejdspartnere og efterforskere

Sponsor

Efterforskere

Datoer for undersøgelser

Studer store datoer

Studiestart (Faktiske)

Primær færdiggørelse (Forventet)

Studieafslutning (Forventet)

Datoer for studieregistrering

Først indsendt

Først indsendt, der opfyldte QC-kriterier

Først opslået (Faktiske)

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

Sidst verificeret

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

IPD-planbeskrivelse

IPD-delingstidsramme

IPD-delingsadgangskriterier

IPD-deling Understøttende informationstype

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Studerer et amerikansk FDA-reguleret enhedsprodukt

Kliniske forsøg med Mavekræft

Kliniske forsøg med exercise group

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in South Africa

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer