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

sunnuntai 19. joulukuuta 2021 päivittänyt: 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:

  1. The fatigue in exercise group is significant improving than usual-care group at 1st, 2nd, 3rd, 6th, 12th, 24th and 36th month.
  2. The negative emotions in exercise group is significant improving than usual-care group at 1st, 2nd, 3rd, 6th, 12th, 24th and 36th month.
  3. The sleep quality in exercise group is significant improving than usual-care group at 1st, 2nd, 3rd, 6th, 12th, 24th and 36th month.
  4. The quality of life in exercise group is significant improving than usual-care group at 1st, 2nd,3rd, 6th, 12th, 24th and 36th month.

Tutkimuksen yleiskatsaus

Tila

Rekrytointi

Ehdot

Interventio / Hoito

Yksityiskohtainen kuvaus

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.

Opintotyyppi

Interventio

Ilmoittautuminen (Odotettu)

160

Vaihe

  • Ei sovellettavissa

Yhteystiedot ja paikat

Tässä osiossa on tutkimuksen suorittajien yhteystiedot ja tiedot siitä, missä tämä tutkimus suoritetaan.

Opiskeluyhteys

Tutki yhteystietojen varmuuskopiointi

Opiskelupaikat

  • Taiwan
      • Taipei county, Taiwan, 112
        • Rekrytointi
        • Taipei Veterans General Hospital
        • Ottaa yhteyttä:
          • Taipei Veterans General Hospital
          • Puhelinnumero: +886-2-2875-7808

Osallistumiskriteerit

Tutkijat etsivät ihmisiä, jotka sopivat tiettyyn kuvaukseen, jota kutsutaan kelpoisuuskriteereiksi. Joitakin esimerkkejä näistä kriteereistä ovat henkilön yleinen terveydentila tai aiemmat hoidot.

Kelpoisuusvaatimukset

Opintokelpoiset iät

20 vuotta - 90 vuotta (Aikuinen, Vanhempi Aikuinen)

Hyväksyy terveitä vapaaehtoisia

Ei

Sukupuolet, jotka voivat opiskella

Kaikki

Kuvaus

Inclusion Criteria:

  1. After undergoing surgery and clinically diagnosed as gastric cancer.
  2. Adults over 20 years old.
  3. Hemoglobin (above 10 g/dL).
  4. Clear consciousness and could communicate in either Mandarin or Taiwanese, and were not cognitively impaired were included.
  5. No lower limb disability and able to walk on their own.

Exclusion Criteria:

  1. Suspected or confirmed bone metastasis.
  2. 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.
  3. Poorly diabetes controlled, glycosylated hemoglobin (HbA1C)>9%, blood sugar higher than 250mg/dl or lower than 80mg/dl.
  4. 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.
  5. Diagnosed as recurrent depression.
  6. Regular exercise above moderate intensity, such as 150 minutes per week in the past three months.

Opintosuunnitelma

Tässä osiossa on tietoja tutkimussuunnitelmasta, mukaan lukien kuinka tutkimus on suunniteltu ja mitä tutkimuksella mitataan.

Miten tutkimus on suunniteltu?

Suunnittelun yksityiskohdat

  • Ensisijainen käyttötarkoitus: Tukevaa hoitoa
  • Jako: Satunnaistettu
  • Inventiomalli: Rinnakkaistehtävä
  • Naamiointi: Yksittäinen

Aseet ja interventiot

Osallistujaryhmä / Arm
Interventio / Hoito
Kokeellinen: exercise group
A 12-week regimen of home-based walking exercises, comprising walking at a moderate intensity for 40 min, three times a Week.
Käyttäytyminen: exercise group

exercise education: A 12-week regimen of homebased walking exercises, include moderate intensity for 40 min, three times a week.

We explained the participants how to perform the exercises, according to an instruction manual for the exercise regimen. Participants were instructed that the exercises would be effective only if they reached 40%-60% of the heart rate reserve, as determined by the Karvonen method, or 13-14 on the RPE.

Exercise education:

Weekly telephone or mobile application "LINE" consultations concerning exercise.we discussed whether participants' exercise fulfilled the prescribed intensity, duration, frequency and whether the participants experienced any adverse effects.
Ei väliintuloa: usual-care group
These participants follows the standard post-surgery follow-up consisting of counseling by dietitians, nurses and doctors.

Mitä tutkimuksessa mitataan?

Ensisijaiset tulostoimenpiteet

Tulosmittaus
Toimenpiteen kuvaus
Aikaikkuna
Quality of Life (EORTC QLQ-C30 )
Aikaikkuna: 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 )
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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

Toissijaiset tulostoimenpiteet

Tulosmittaus
Toimenpiteen kuvaus
Aikaikkuna
fatigue(Brief Fatigue Inventory-Taiwan , BFI-T)
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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

Yhteistyökumppanit ja tutkijat

Täältä löydät tähän tutkimukseen osallistuvat ihmiset ja organisaatiot.

Sponsori

Taipei Veterans General Hospital, Taiwan

Tutkijat

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

Opintojen ennätyspäivät

Nämä päivämäärät seuraavat ClinicalTrials.gov-sivustolle lähetettyjen tutkimustietueiden ja yhteenvetojen edistymistä. National Library of Medicine (NLM) tarkistaa tutkimustiedot ja raportoidut tulokset varmistaakseen, että ne täyttävät tietyt laadunvalvontastandardit, ennen kuin ne julkaistaan ​​julkisella verkkosivustolla.

Opi tärkeimmät päivämäärät

Opiskelun aloitus (Todellinen)

Tiistai 10. marraskuuta 2020

Ensisijainen valmistuminen (Odotettu)

Torstai 31. lokakuuta 2024

Opintojen valmistuminen (Odotettu)

Perjantai 31. lokakuuta 2025

Opintoihin ilmoittautumispäivät

Ensimmäinen lähetetty

Maanantai 21. syyskuuta 2020

Ensimmäinen toimitettu, joka täytti QC-kriteerit

Tiistai 13. lokakuuta 2020

Ensimmäinen Lähetetty (Todellinen)

Maanantai 19. lokakuuta 2020

Tutkimustietojen päivitykset

Viimeisin päivitys julkaistu (Todellinen)

Tiistai 21. joulukuuta 2021

Viimeisin lähetetty päivitys, joka täytti QC-kriteerit

Sunnuntai 19. joulukuuta 2021

Viimeksi vahvistettu

Keskiviikko 1. joulukuuta 2021

Lisää tietoa

Tähän tutkimukseen liittyvät termit

Avainsanat

Muita asiaankuuluvia MeSH-ehtoja

Muut tutkimustunnusnumerot

  • 2020-10-006A

Yksittäisten osallistujien tietojen suunnitelma (IPD)

Aiotko jakaa yksittäisten osallistujien tietoja (IPD)?

JOO

IPD-suunnitelman kuvaus

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

IPD-jaon aikakehys

Beginning 12 months following article publication

IPD-jaon käyttöoikeuskriteerit

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

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  • STUDY_PROTOCOL

Lääke- ja laitetiedot, tutkimusasiakirjat

Tutkii yhdysvaltalaista FDA sääntelemää lääkevalmistetta

Ei

Tutkii yhdysvaltalaista FDA sääntelemää laitetuotetta

Ei

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