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临床试验/NCT03607877
NCT03607877已完成不适用

Gender Differences and Influence of Walking Exercise and a Psychosocial Intervention on Psychological Well-being and Sense of Coherence Amongst Retried Senior Citizens

National Defense Medical Center, Taiwan0 个研究点目标入组 150 人开始时间: 2010年9月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
150
主要终点
Cardiovascular fitness

研究概览

简要总结

Three arms of experimental design were used: Pedometer walking training (PWT), positive education and pedometer walking training (PEPWT), and pedometer walking (PW). Trained walking exercise was provided by a physical education expert three times per week, 45 minutes per session. Positive education was designed and led by a licensed psychologist. Six sessions of activities targeted participants' self-strength, competence and self-efficacy in walking exercise; positive relations with others; and positive emotions about life and healthy lifestyle. Of 150 participants, 60, 60 and 30 were randomly assigned to PWT, PEPWT, and PW, respectively. Demographic information, Chinese Happiness Inventory (CHI), regular walking exercise and six-minute walking distance were assessed before and after the intervention.

详细描述

Randomization (allocation ratio 2:2:1) was stratified to three arms: pedometer walking (PW), pedometer walking with training (PWT), and positive education and pedometer walking with training (PEPWT). Randomization was conducted using opaque envelops and a randomly generated number sequence by an independent research assistant who had no prior knowledge of the recruited elders. Researchers allocated participants to their treatment condition based on the randomization code in the sealed envelope (opened in order of sequence). Researchers were not blind to the patients' treatment allocation.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Investigator)

盲法说明

Randomization was conducted using opaque envelops and a randomly generated number sequence by an independent research assistant who had no prior knowledge of the recruited elders. Researchers allocated participants to their treatment condition based on the randomization code in the sealed envelope (opened in order of sequence). Investigator was blind to participants, but researchers were not blind to the patients' treatment allocation.

入排标准

年龄范围
55 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Inclusion criteria included being retired from work and being at least 55 years old.

排除标准

  • Elders who had cardiovascular disease, who were unable to walk, who had dementia or psychiatric disease, who already exercised regularly, or who were unwilling to sign the consent form were excluded from the study.

研究组 & 干预措施

pedometer walking with training (PWT)

Active Comparator

15 minutes of warm-up activities, 30 minutes of walking, and 10 minutes to cool down. Exercise intensity for the first four weeks was 50-55% heart rate reserve (HRR) with training for 3 months.

干预措施: Pedometer walking with training (Behavioral)

positive education and walking (PEPWT)

Experimental

PEPWT: 15 minutes of warm-up activities, 30 minutes of walking, and 10 minutes to cool down for 3 months and six sessions of positive education.

干预措施: Pedometer walking training and positive education (Behavioral)

pedometer walking (PW)

Active Comparator

15 minutes of warm-up activities, 30 minutes of walking, and 10 minutes to cool down for 3 months.

干预措施: pedometer walking (Behavioral)

结局指标

主要结局

Cardiovascular fitness

时间窗: 3 months

Cardiovascular fitness was calculated by using the six-minute walk test (6MWT) which measures the distance an individual is able to walk over a total of six minutes on a hard, flat surface and has been suggested as a useful outcome tool (Du, Newton, Salamonson, Carrieri-Kohlman, \& Davidson, 2009). The goal is for the individual to walk as far as possible in six minutes. The individual is allowed to self-pace and rest as needed as they traverse back and forth along a marked walkway. The 6MWT has been used to detect changes following interventions to improve exercise tolerance for healthy older adults (Troosters, Gosselink, \& Decramer, 1999).

Chinese Happiness Inventory

时间窗: 3 months

Chinese Happiness Inventory (CHI). The CHI 20-item version has been widely used to measure individual well-being in Chinese culture (Lu \& Shih, 1997; Chiang, Lin, \& Lee, 2016). Each statement represents a different level of happiness, ranging from 0 (very dissatisfied) to 3 (very satisfied). CHI score is the sum of 20 items. The higher the score is, the higher the psychological well-being is. CHI has high validity and reliability (Lu \& Shih, 1997; Chiang, Lin, \& Lee, 2016).

次要结局

未报告次要终点

研究者

发起方
National Defense Medical Center, Taiwan
申办方类型
Other
责任方
Principal Investigator
主要研究者

Hui-Hsun Chiang

Assistant Professor

National Defense Medical Center, Taiwan

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