HappinessRCTNCT03607877
A RCT of Walking With Positive Education in Retired Elders
A study testing Pedometer walking training and positive education, Pedometer walking with training and pedometer walking in people with Happiness and Educational Problems, run by National Defense Medical Center, Taiwan.
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. Read more about this study
- Who is it for?
- Ages 55 years and olderHealthy volunteers can take part
- Conditions the study is for
- Happiness, Educational Problems, Exercise
- What is being tested?
- Pedometer walking training and positive education, Pedometer walking with training and pedometer walking
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2010to 30 Jun 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Inclusion criteria included being retired from work and being at least 55 years old.
Who cannot join
- 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.
About this study
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
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.
Read the 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.
- Conditions
- Happiness, Educational Problems, Exercise
- Being tested
- Pedometer walking training and positive education, Pedometer walking with training, pedometer walking
- Keywords
- Positive education, Walking exercise, Well-being, Pedometer, Cardiovascular fitness
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pedometer walking training and positive educationBehavioural
Also called walking exercise
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 trainingBehavioural
Also called walking exercise
Intervention:walk at least 30 minutes per day and at least three times per week with family support and exercise companions.
pedometer walkingBehavioural
Also called walking
Intervention: pedometer walking at least 30 minutes per day and at least three times per week
| Study group | Role | What they receive |
|---|---|---|
| pedometer walking (PW) | Active comparator | 15 minutes of warm-up activities, 30 minutes of walking, and 10 minutes to cool down for 3 months. Receives: Behavioral: pedometer walking |
| 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. Receives: Behavioral: Pedometer walking with training |
| 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. Receives: Behavioral: Pedometer walking training and positive education |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 3 months
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).
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2018
- Study start1 Sep 2010
- Primary completion6 Mar 2012
- Study completion30 Jun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HappinessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Defense Medical Center, Taiwan
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Science and Technology, Taiwan
- Responsible party
- Principal investigator, Hui-Hsun Chiang, National Defense Medical Center, Taiwan
- Investigators
- Tony Szu-Hsien Lee, Prof, Principal investigator, Health Education and Health Promotion, National Taiwan Normal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03607877
- Sponsor's protocol ID
- Exercise and Psychology
- Acronym
- RCT
- Status last verified
- Jul 2018
- First submitted
- 13 Jul 2018
- Last updated
- 31 Jul 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 18694656
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03607877
- Acronym / sponsor ID
- RCT / Exercise and Psychology
- Conditions
- Happiness, Educational Problems, Exercise
- Keywords
- Positive education, Walking exercise, Well-being, Pedometer, Cardiovascular fitness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- National Defense Medical Center, TaiwanUniversity, hospital or other
- Collaborators
- Ministry of Science and Technology, Taiwan
- Study start
- 1 Sep 2010 (actual)
- Primary completion
- 6 Mar 2012 (actual)
- Study completion
- 30 Jun 2012 (actual)
- First posted
- 31 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| pedometer walking (PW) | Active comparator | Behavioral: pedometer walking15 minutes of warm-up activities, 30 minutes of walking, and 10 minutes to cool down for 3 months. |
| pedometer walking with training (PWT) | Active comparator | Behavioral: Pedometer walking with training15 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. |
| positive education and walking (PEPWT) | Experimental | Behavioral: Pedometer walking training and positive educationPEPWT: 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. |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Inclusion criteria included being retired from work and being at least 55 years old.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pedometer walking training and positive educationAlso: walking exerciseIntervention: (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. | Behavioural | positive education and walking (PEPWT) |
| Pedometer walking with trainingAlso: walking exerciseIntervention:walk at least 30 minutes per day and at least three times per week with family support and exercise companions. | Behavioural | pedometer walking with training (PWT) |
| pedometer walkingAlso: walkingIntervention: pedometer walking at least 30 minutes per day and at least three times per week | Behavioural | pedometer walking (PW) |
Primary outcome
Chinese Happiness Inventory
Time frame: 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).
Cardiovascular fitness
Time frame: 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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2018.
- Results publication: PubMed 18694656Du 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.
- Meta-analysisLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tony Szu-Hsien Lee, Prof principal investigator
Health Education and Health Promotion, National Taiwan Normal University
Questions about this trial
What is this clinical trial studying?
A study testing Pedometer walking training and positive education, Pedometer walking with training and pedometer walking in people with Happiness and Educational Problems, run by National Defense Medical Center, Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Chinese Happiness Inventory (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03607877, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2018.