Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000077369
Ethics application status
Approved
Date submitted
8/12/2016
Date registered
13/01/2017
Date last updated
30/01/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Effects of a whole body dynamic exercise program on hip mobility and balance
in healthy older adults
Scientific title
Effectiveness of a whole body dynamic exercise program versus home exercise education sheets on hip mobility, balance, and self-perceive change in healthy older adults
Secondary ID [1] 290709 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
healthy 301380 0
Condition category
Condition code
Physical Medicine / Rehabilitation 301026 301026 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention group will receive a 10-week, twice a week of a whole body dynamic exercise intervention program.The duration of each training session will be 60 minutes. Each class will begin on a chair with a gentle warm up sequence to move the trunk and upper extremities. This is followed by a series of fluid spinal motions which increase range of motion, and prepare the body to explore more complex movements with agility, and ease based on GYROKINESIS 'Registered Trademark' method. The exercise training will be delivered in a group format with a physiotherapist who is also a certified GYROKINESIS trainer. The mode of delivery is face to face and is in a group format. The location will be at local Community Activity Centers. An exercise log will be documented by the exercise physiotherapist.
Intervention code [1] 296601 0
Rehabilitation
Comparator / control treatment
The control group will receive home exercise education sheets at the first visit and reviewed at the midterm (6-week) visit. The exercise sheets with general stretching exercises are developed specifically for this study. Participants instructed to exercise at their own discretion. An exercise log was given to participants in the control group to improve fidelity.
Control group
Active

Outcomes
Primary outcome [1] 300447 0
Hip passive range of motion assessed by a smartphone inclinometer.
Timepoint [1] 300447 0
Baseline, 6-week midterm test, and post-test after 10-week intervention.
Primary outcome [2] 300448 0
Hip active range of motion assessed by the Chair Sit and Reach Test (CSR).
Timepoint [2] 300448 0
Baseline, 6-week midterm test, and post-test after 10-week intervention.
Primary outcome [3] 300449 0
Balance ability assessed by the Brief Balance Evaluation Systems Test (Brief-BESTest).
Timepoint [3] 300449 0
Baseline, 6-week midterm test, and post-test after 10-week intervention.
Secondary outcome [1] 330005 0
perceive change assessed by the Lower Extremity Functional Scale (LEFS)
Timepoint [1] 330005 0
Baseline, 6-week midterm test, and post-test after 10-week intervention.
Secondary outcome [2] 330006 0
perceive change assessed by the Global Rating of Change (GROC).
Timepoint [2] 330006 0
Baseline, 6-week midterm test, and post-test after 10-week intervention.

Eligibility
Key inclusion criteria
1. Aged >=60 years
2. Healthy participants whi can ambulate independently
3. Able to follow instructions
Minimum age
60 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Need to use any assistive walking device to ambulate
2. History of previous hip fracture or hip surgery leading to obvious restriction of hip mobility
3. Medical or pharmacological contraindications to exercise
4. Severe physical dysfunctions
5. Moderate intellectual impairment indicated by the Short Portable Mental State Questionnaire (SPMSQ)

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
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
17/01/2017
Actual
16/01/2017
Date of last participant enrolment
Anticipated
Actual
8/05/2017
Date of last data collection
Anticipated
Actual
7/08/2017
Sample size
Target
60
Accrual to date
Final
60
Recruitment outside Australia
Country [1] 8468 0
Taiwan, Province Of China
State/province [1] 8468 0

Funding & Sponsors
Funding source category [1] 295137 0
University
Name [1] 295137 0
National Yang-Ming University
Country [1] 295137 0
Taiwan, Province Of China
Primary sponsor type
University
Name
National Yang-Ming University
Address
155, Sec. 2, Li-Nong St. Beitou District, Taipei, 11221, Taiwan
Country
Taiwan, Province Of China
Secondary sponsor category [1] 293958 0
None
Name [1] 293958 0
Address [1] 293958 0
Country [1] 293958 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296485 0
National Yang-Ming University Institutional Review Board (IRB)
Ethics committee address [1] 296485 0
Ethics committee country [1] 296485 0
Taiwan, Province Of China
Date submitted for ethics approval [1] 296485 0
27/08/2016
Approval date [1] 296485 0
27/10/2016
Ethics approval number [1] 296485 0
YM105070F

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

Contacts
Principal investigator
Name 71030 0
A/Prof Tzyy-Jiuan Wang
Address 71030 0
National Yang-Ming University
No.155, Sec.2, Linong Street, Beitou District, 11221, Taipei
Country 71030 0
Taiwan, Province Of China
Phone 71030 0
+886228267091
Fax 71030 0
+886228201841
Email 71030 0
[email protected]
Contact person for public queries
Name 71031 0
Tzyy-Jiuan Wang
Address 71031 0
National Yang-Ming University
No.155, Sec.2, Linong Street, Beitou District, 11221, Taipei
Country 71031 0
Taiwan, Province Of China
Phone 71031 0
+886228267091
Fax 71031 0
+886228201841
Email 71031 0
[email protected]
Contact person for scientific queries
Name 71032 0
Tzyy-Jiuan Wang
Address 71032 0
National Yang-Ming University
No.155, Sec.2, Linong Street, Beitou District, 11221, Taipei
Country 71032 0
Taiwan, Province Of China
Phone 71032 0
+886228267091
Fax 71032 0
+886228201841
Email 71032 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.