Effectiveness of Exercise Program in Improving Quality of Life in Patients With Gastric Cancer Undergoing Gastrectomy
19 december 2021 bijgewerkt door: 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.
Studie Overzicht
Gedetailleerde beschrijving
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.
Studietype
Ingrijpend
Inschrijving (Verwacht)
160
Fase
- Niet toepasbaar
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studiecontact
- Naam: HUI-MEI CHEN, PhD
- Telefoonnummer: 886-939654302
- E-mail: alice@ntunhs.edu.tw
Studie Contact Back-up
- Naam: Pei-Shan Ho, BSN
- Telefoonnummer: 886-933937197
- E-mail: psho@vghtpe.gov.tw
Studie Locaties
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Taipei county, Taiwan, 112
- Werving
- Taipei Veterans General Hospital
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Contact:
- Taipei Veterans General Hospital
- Telefoonnummer: +886-2-2875-7808
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
20 jaar tot 90 jaar (Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Allemaal
Beschrijving
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.
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Ondersteunende zorg
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Enkel
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: 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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Geen tussenkomst: usual-care group
These participants follows the standard post-surgery follow-up consisting of counseling by dietitians, nurses and doctors.
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Quality of Life (EORTC QLQ-C30 )
Tijdsspanne: baseline (one week after recruited)
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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.
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baseline (one week after recruited)
|
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Quality of Life (EORTC QLQ-C30 )
Tijdsspanne: 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
|
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Quality of Life (EORTC QLQ-C30)
Tijdsspanne: 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
|
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Quality of Life (EORTC QLQ-C30)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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
|
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Quality of Life (EORTC QLQ-STO22)
Tijdsspanne: 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)
|
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Quality of Life (EORTC QLQ-STO22)
Tijdsspanne: 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.
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1st month after recruited
|
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Quality of Life (EORTC QLQ-STO22)
Tijdsspanne: 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
|
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Quality of Life (EORTC QLQ-STO22)
Tijdsspanne: 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
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Quality of Life (EORTC QLQ-STO22)
Tijdsspanne: 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
|
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Quality of Life (EORTC QLQ-STO22)
Tijdsspanne: 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
|
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Quality of Life (EORTC QLQ-STO22)
Tijdsspanne: 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
|
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Quality of Life (EORTC QLQ-STO22)
Tijdsspanne: 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.
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36th month after recruited
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
fatigue(Brief Fatigue Inventory-Taiwan , BFI-T)
Tijdsspanne: 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)
|
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fatigue(Brief Fatigue Inventory-Taiwan , BFI-T)
Tijdsspanne: 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
|
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fatigue(Brief Fatigue Inventory-Taiwan , BFI-T)
Tijdsspanne: 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
|
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fatigue(Brief Fatigue Inventory-Taiwan , BFI-T)
Tijdsspanne: 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
|
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fatigue(Brief Fatigue Inventory-Taiwan , BFI-T)
Tijdsspanne: 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
|
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fatigue(Brief Fatigue Inventory-Taiwan , BFI-T)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
|
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Emotional distress( Hospital Anxiety and Depression Scale, HADS)
Tijdsspanne: 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.
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1st month after recruited
|
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Emotional distress( Hospital Anxiety and Depression Scale, HADS)
Tijdsspanne: 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
|
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Emotional distress( Hospital Anxiety and Depression Scale, HADS)
Tijdsspanne: 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
|
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Emotional distress( Hospital Anxiety and Depression Scale, HADS)
Tijdsspanne: 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
|
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Emotional distress( Hospital Anxiety and Depression Scale, HADS)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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
|
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sleep quality(Pittsburgh Sleep Quality Index and using Actigraph)
Tijdsspanne: 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)
|
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sleep quality(Pittsburgh Sleep Quality Index and using Actigraph)
Tijdsspanne: 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
|
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sleep quality(Pittsburgh Sleep Quality Index and using Actigraph)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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
|
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Circadian rhythms(using Actigraph)
Tijdsspanne: 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.
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baseline (one week after recruited)
|
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Circadian rhythms(using Actigraph)
Tijdsspanne: 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.
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3rd month after recruited
|
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Circadian rhythms(using Actigraph)
Tijdsspanne: 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.
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6th month after recruited
|
|
Circadian rhythms(using Actigraph)
Tijdsspanne: 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
|
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Circadian rhythms(using Actigraph)
Tijdsspanne: 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.
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24th month after recruited
|
|
Circadian rhythms(using Actigraph)
Tijdsspanne: 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.
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36th month after recruited
|
Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Onderzoekers
- Studie stoel: Hui-Mei Chen, PhD, National Taipei University of Nursing and Health Sciences, Taipei, Taiwan
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Werkelijk)
10 november 2020
Primaire voltooiing (Verwacht)
31 oktober 2024
Studie voltooiing (Verwacht)
31 oktober 2025
Studieregistratiedata
Eerst ingediend
21 september 2020
Eerst ingediend dat voldeed aan de QC-criteria
13 oktober 2020
Eerst geplaatst (Werkelijk)
19 oktober 2020
Updates van studierecords
Laatste update geplaatst (Werkelijk)
21 december 2021
Laatste update ingediend die voldeed aan QC-criteria
19 december 2021
Laatst geverifieerd
1 december 2021
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 2020-10-006A
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
JA
Beschrijving IPD-plan
Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
IPD-tijdsbestek voor delen
Beginning 12 months following article publication
IPD-toegangscriteria voor delen
Researchers who provide a methodologically sound proposal and receive the authors consent.
IPD delen Ondersteunend informatietype
- LEERPROTOCOOL
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .