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

19 de dezembro de 2021 atualizado por: 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.

Visão geral do estudo

Status

Recrutamento

Condições

Intervenção / Tratamento

Descrição detalhada

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.

Tipo de estudo

Intervencional

Inscrição (Antecipado)

160

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

Estude backup de contato

Locais de estudo

  • Taiwan
      • Taipei county, Taiwan, 112
        • Recrutamento
        • Taipei Veterans General Hospital
        • Contato:
          • Taipei Veterans General Hospital
          • Número de telefone: +886-2-2875-7808

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

20 anos a 90 anos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Descrição

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.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Cuidados de suporte
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Solteiro

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: exercise group
A 12-week regimen of home-based walking exercises, comprising walking at a moderate intensity for 40 min, three times a Week.
Comportamental: 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.
Sem intervenção: usual-care group
These participants follows the standard post-surgery follow-up consisting of counseling by dietitians, nurses and doctors.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Quality of Life (EORTC QLQ-C30 )
Prazo: 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 )
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
fatigue(Brief Fatigue Inventory-Taiwan , BFI-T)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Taipei Veterans General Hospital, Taiwan

Investigadores

  • Cadeira de estudo: Hui-Mei Chen, PhD, National Taipei University of Nursing and Health Sciences, Taipei, Taiwan

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

10 de novembro de 2020

Conclusão Primária (Antecipado)

31 de outubro de 2024

Conclusão do estudo (Antecipado)

31 de outubro de 2025

Datas de inscrição no estudo

Enviado pela primeira vez

21 de setembro de 2020

Enviado pela primeira vez que atendeu aos critérios de CQ

13 de outubro de 2020

Primeira postagem (Real)

19 de outubro de 2020

Atualizações de registro de estudo

Última Atualização Postada (Real)

21 de dezembro de 2021

Última atualização enviada que atendeu aos critérios de controle de qualidade

19 de dezembro de 2021

Última verificação

1 de dezembro de 2021

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • 2020-10-006A

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

SIM

Descrição do plano IPD

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

Prazo de Compartilhamento de IPD

Beginning 12 months following article publication

Critérios de acesso de compartilhamento IPD

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

Tipo de informação de suporte de compartilhamento de IPD

  • PROTOCOLO DE ESTUDO

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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