Effectiveness of Exercise Program in Improving Quality of Life in Patients With Gastric Cancer Undergoing Gastrectomy
19 december 2021 uppdaterad av: 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.
Studieöversikt
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Förväntat)
160
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studiekontakt
- Namn: HUI-MEI CHEN, PhD
- Telefonnummer: 886-939654302
- E-post: alice@ntunhs.edu.tw
Studera Kontakt Backup
- Namn: Pei-Shan Ho, BSN
- Telefonnummer: 886-933937197
- E-post: psho@vghtpe.gov.tw
Studieorter
-
-
-
Taipei county, Taiwan, 112
- Rekrytering
- Taipei Veterans General Hospital
-
Kontakt:
- Taipei Veterans General Hospital
- Telefonnummer: +886-2-2875-7808
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
20 år till 90 år (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Stödjande vård
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: exercise group
A 12-week regimen of home-based walking exercises, comprising walking at a moderate intensity for 40 min, three times a Week.
|
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. |
|
Inget ingripande: usual-care group
These participants follows the standard post-surgery follow-up consisting of counseling by dietitians, nurses and doctors.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Quality of Life (EORTC QLQ-C30 )
Tidsram: 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 )
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
fatigue(Brief Fatigue Inventory-Taiwan , BFI-T)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Utredare
- Studiestol: Hui-Mei Chen, PhD, National Taipei University of Nursing and Health Sciences, Taipei, Taiwan
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
10 november 2020
Primärt slutförande (Förväntat)
31 oktober 2024
Avslutad studie (Förväntat)
31 oktober 2025
Studieregistreringsdatum
Först inskickad
21 september 2020
Först inskickad som uppfyllde QC-kriterierna
13 oktober 2020
Första postat (Faktisk)
19 oktober 2020
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
21 december 2021
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
19 december 2021
Senast verifierad
1 december 2021
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 2020-10-006A
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
JA
IPD-planbeskrivning
Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
Tidsram för IPD-delning
Beginning 12 months following article publication
Kriterier för IPD Sharing Access
Researchers who provide a methodologically sound proposal and receive the authors consent.
IPD-delning som stöder informationstyp
- STUDY_PROTOCOL
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .