Effectiveness of Exercise Program in Improving Quality of Life in Patients With Gastric Cancer Undergoing Gastrectomy
19 décembre 2021 mis à jour par: 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.
Aperçu de l'étude
Statut
Recrutement
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Interventionnel
Inscription (Anticipé)
160
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Coordonnées de l'étude
- Nom: HUI-MEI CHEN, PhD
- Numéro de téléphone: 886-939654302
- E-mail: alice@ntunhs.edu.tw
Sauvegarde des contacts de l'étude
- Nom: Pei-Shan Ho, BSN
- Numéro de téléphone: 886-933937197
- E-mail: psho@vghtpe.gov.tw
Lieux d'étude
-
-
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Taipei county, Taïwan, 112
- Recrutement
- Taipei Veterans General Hospital
-
Contact:
- Taipei Veterans General Hospital
- Numéro de téléphone: +886-2-2875-7808
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-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
20 ans à 90 ans (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
La description
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 d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Soins de soutien
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: exercise group
A 12-week regimen of home-based walking exercises, comprising walking at a moderate intensity for 40 min, three times a Week.
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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. |
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Aucune intervention: usual-care group
These participants follows the standard post-surgery follow-up consisting of counseling by dietitians, nurses and doctors.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Quality of Life (EORTC QLQ-C30 )
Délai: 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 )
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
fatigue(Brief Fatigue Inventory-Taiwan , BFI-T)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Chaise d'étude: Hui-Mei Chen, PhD, National Taipei University of Nursing and Health Sciences, Taipei, Taiwan
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
10 novembre 2020
Achèvement primaire (Anticipé)
31 octobre 2024
Achèvement de l'étude (Anticipé)
31 octobre 2025
Dates d'inscription aux études
Première soumission
21 septembre 2020
Première soumission répondant aux critères de contrôle qualité
13 octobre 2020
Première publication (Réel)
19 octobre 2020
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
21 décembre 2021
Dernière mise à jour soumise répondant aux critères de contrôle qualité
19 décembre 2021
Dernière vérification
1 décembre 2021
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 2020-10-006A
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
OUI
Description du régime IPD
Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
Délai de partage IPD
Beginning 12 months following article publication
Critères d'accès au partage IPD
Researchers who provide a methodologically sound proposal and receive the authors consent.
Type d'informations de prise en charge du partage d'IPD
- PROTOCOLE D'ÉTUDE
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .