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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03607877
Other study ID # Exercise and Psychology
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 1, 2010
Est. completion date June 30, 2012

Study information

Verified date July 2018
Source National Defense Medical Center, Taiwan
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

Status Completed
Enrollment 150
Est. completion date June 30, 2012
Est. primary completion date March 6, 2012
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 55 Years and older
Eligibility Inclusion Criteria:

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

Exclusion Criteria:

- 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.

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Pedometer walking training and positive education
Intervention: (1)Positive education: Six psychosocial sessions were designed to enhance elders' positive emotion, motivation and self-efficacy to walk. (2) Pedometer walking training: walk at least 30 minutes per day and at least three times per week with family support and exercise companions.
Pedometer walking with training
Intervention:walk at least 30 minutes per day and at least three times per week with family support and exercise companions.
pedometer walking
Intervention: pedometer walking at least 30 minutes per day and at least three times per week

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
National Defense Medical Center, Taiwan Ministry of Science and Technology, Taiwan

References & Publications (1)

Du H, Newton PJ, Salamonson Y, Carrieri-Kohlman VL, Davidson PM. A review of the six-minute walk test: its implication as a self-administered assessment tool. Eur J Cardiovasc Nurs. 2009 Mar;8(1):2-8. doi: 10.1016/j.ejcnurse.2008.07.001. Epub 2008 Aug 9. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Chinese Happiness Inventory 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). 3 months
Primary Cardiovascular fitness 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). 3 months
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