Clinical trial NCT03607877: A RCT of Walking With Positive Education in Retired Elders
Official title: Gender Differences and Influence of Walking Exercise and a Psychosocial Intervention on Psychological Well-being and Sense of Coherence Amongst Retried Senior Citizens
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Happiness
Educational Problems
Exercise
Keywords: Positive education
Walking exercise
Well-being
Pedometer
Cardiovascular fitness
Lead sponsor: National Defense Medical Center, Taiwan
Sponsor class: OTHER
Collaborators: name: Ministry of Science and Technology, Taiwan
First posted: 2018-07-31
Enrollment: 150
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Chinese Happiness Inventory
timeFrame: 3 months
measure: Cardiovascular fitness
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Health Education and Health Promotion, National Taiwan Normal University
name: Tony Szu-Hsien Lee, Prof
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.