Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001401246
Ethics application status
Approved
Date submitted
10/08/2018
Date registered
21/08/2018
Date last updated
21/08/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effect of outdoor fitness equipment in elderly
Scientific title
Does outdoor fitness equipment in park benefit seniors’ functional fitness?
Secondary ID [1] 295769 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Functional ability development in healthy elderly 309170 0
Condition category
Condition code
Public Health 308047 308047 0 0
Other public health

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The 12-week progressive training protocol was designed based on the American College of Sports Medicine (ACSM) recommendation for seniors with outdoor fitness equipment (OFE).
This protocol was progressive, with three sessions per week involving three types of OFE, including the air walker, arm stretcher, and leg press machine for aerobic, flexibility, and muscle strength training respectively. Each session included warm-up, the main exercise, and cool-down period. To warm up, all participants walked around the park at their preferred speed for 5 minutes and then stretched statically for 5 minutes. To cool down, all participants stretched statically for 5 minutes. All exercises were performed under the premise of ensuring seniors’ safety. The related details of training protocol were shown as below:
a) The intervention group underwent a 12-week training with 3 sessions per week. The duration progressively increased from 60 to 90 minutes.
b) The mode of administration: Three groups of 7 who were instructed by sports scientists and an athletic trainer.
c) The target intensity: The intensity of aerobic activity was brisk walking pace (as quickly as they can). The intensity of flexibility activity was stretching until tightness or equipment limitation. The intensity of strength was their own body weight.
d) The strategies used to monitor adherence to the intervention: Training protocol was carried out and supervised by sports scientists and an athletic trainer.
Intervention code [1] 312096 0
Treatment: Other
Intervention code [2] 312153 0
Lifestyle
Intervention code [3] 312154 0
Prevention
Comparator / control treatment
The control group did not undergo any training instruction or intervention during the 12-week period and were asked to simply maintain their usual lifestyles.
Control group
Active

Outcomes
Primary outcome [1] 307039 0
Cardiopulmonary function: 2-minute step test
Timepoint [1] 307039 0
Assessments were conducted 2 days before and after the 12-week intervention.
Primary outcome [2] 307040 0
Flexibility of the upper limb: back scratch test
Timepoint [2] 307040 0
Assessments were conducted 2 days before and after the 12-week intervention.
Primary outcome [3] 307041 0
Muscle strength of lower limb: 30-second sit-to-stand test
Timepoint [3] 307041 0
Assessments were conducted 2 days before and after the 12-week intervention.
Secondary outcome [1] 350457 0
Balance: timed-up-and-go test
Timepoint [1] 350457 0
Assessments were conducted 2 days before and after the 12-week intervention.
Secondary outcome [2] 350725 0
Flexibility of lower limb: chair sit-and-reach test
Timepoint [2] 350725 0
Assessments were conducted 2 days before and after the 12-week intervention.
Secondary outcome [3] 350726 0
Muscle strength of upper limb: 30-second arm curl test
Timepoint [3] 350726 0
Assessments were conducted 2 days before and after the 12-week intervention.

Eligibility
Key inclusion criteria
elderly over 65 yrs.
Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
History of any major illness in the past 6 months

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
30/04/2015
Date of last participant enrolment
Anticipated
Actual
5/07/2015
Date of last data collection
Anticipated
Actual
11/10/2015
Sample size
Target
50
Accrual to date
Final
42
Recruitment outside Australia
Country [1] 20738 0
Taiwan, Province Of China
State/province [1] 20738 0

Funding & Sponsors
Funding source category [1] 300357 0
Government body
Name [1] 300357 0
Ministry of Science and Technology of Taiwan
Country [1] 300357 0
Taiwan, Province Of China
Primary sponsor type
Government body
Name
Ministry of Science and Technology of Taiwan
Address
NO. 106, Sec. 2, Heping E. Rd., Taipei 10622, Taiwan, R.O.C.
Country
Taiwan, Province Of China
Secondary sponsor category [1] 299803 0
None
Name [1] 299803 0
None.
Address [1] 299803 0
None.
Country [1] 299803 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301171 0
Antai Medical Care Cooperation Antai Tian-Sheng Memorial Hospital
Ethics committee address [1] 301171 0
Ethics committee country [1] 301171 0
Taiwan, Province Of China
Date submitted for ethics approval [1] 301171 0
Approval date [1] 301171 0
01/07/2014
Ethics approval number [1] 301171 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 86090 0
Dr Ya-Chen Liu
Address 86090 0
The Office of Physical Education, Chung Hua University
No. 707, Sec.2, WuFu Rd., Hsinchu, 30012 Taiwan (ROC)
Country 86090 0
Taiwan, Province Of China
Phone 86090 0
+88635374281
Fax 86090 0
Email 86090 0
[email protected]
Contact person for public queries
Name 86091 0
Ya-Chen Liu
Address 86091 0
The Office of Physical Education, Chung Hua University
No. 707, Sec.2, WuFu Rd., Hsinchu, 30012 Taiwan (ROC)
Country 86091 0
Taiwan, Province Of China
Phone 86091 0
+88635374281
Fax 86091 0
Email 86091 0
[email protected]
Contact person for scientific queries
Name 86092 0
Ya-Chen Liu
Address 86092 0
The Office of Physical Education, Chung Hua University
No. 707, Sec.2, WuFu Rd., Hsinchu, 30012 Taiwan (ROC)
Country 86092 0
Taiwan, Province Of China
Phone 86092 0
+88635374281
Fax 86092 0
Email 86092 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.