- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05343897
Effects of Ping-Shuai-Gong and Arm-Swing-Exercise
Training Effects on Ping-Shuai-Gong and Arm-Swing-Exercise
Study Overview
Status
Conditions
Detailed Description
With the development of an aging society, the health and social systems of the elderly population have become issues that cannot be ignored. Due to the features of low difficulty and small space requirements, Ping Shuai Gong (PSG) and Arm Swing Exercise (ASE) become very popular within the older population. These physical activities have been proved to show advancement in cardiovascular and physical functions. Hence, this study is design to explores the health effects of two different arm-swinging strategies, and to explore the relationship between characteristics of arm-swinging movement and skin blood flow during exercise.
40 elderly people over 60 years old who have no regular exercise habits were divided into PSG group and ASE group, and each group was given two months of exercise training (at least 24 times of exercise, 30 minutes totally within one day). PSG group was asked to perform PSG exercises (actions were synchronized with the hands raised to shoulder height and then swinging down and back, with two squatting movements at the fifth time). ASE group was asked to perform ASE exercises (actions were to raise both hands synchronously to a 30-degree bend and then 60-degree shoulder extension, and to control the stability of the upper body when swinging arms).
Evaluation procedures of the pretraining evaluation and post-training evaluation are exactly the same.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Tainan, Taiwan
- National Cheng Kung University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
age over 60 able to stand unassisted for at least 30 minutes able to understand and follow the instructions no good exercise habits (frequency > 3 times / wk.), intensity (rated perceived exertion > 12/20), time > 30 min.) for at least 3 months able to attend the experiment for 2 months
Exclusion Criteria:
uncontrolled cardiovascular disease severe arrhythmia peripheral artery disease respiratory system diseasehemodialysis patients unresolved upper or lower extremity injury
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: 2-month Ping-Shuai Gong (PSG) training
Ping-Shuai Gong (PSG) is pioneered by Qi Gong master, Li Feng-shan. It is featured in synchronous and rhythmic arm-swinging movement, with arms straightly forward flexing to shoulder level and backward extending repeatedly, and combined with lightly squat twice while arms swing to the fifth time and continue this cycle. They were asked to conduct and record 30 minutes of PSG in one day lasting for 2-month, and at least 3 days a week. |
Participants were asked to conduct and record 30 minutes of PSG in one day lasting for 2-month, and at least 3 days a week.
A record sheet were sent to the participants in the first time, and the contact information of examiner were given as well.
The examiner will check the completion of exercise execution via phone every two to three days and visit participants to confirm the correctness of movement at least one time during the 2-month intervention period.
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Active Comparator: 2-month Arm-Swing-Exercise (ASE) training
Participents in Arm-Swing-Exercise (ASE) group were instructed to keep whole upper limbs pronated, and maintain their trunk straight while movement. The movement is to swing bilateral arms forward to around 30 degree and backward to around 60 degree continuously. The participants need to stabilize their trunk, pelvic, and legs while bilateral arms swinging passing through the side of the trunk. The most significant difference from PSG group is the way they pull the arm, not just swing backward and downward. They were asked to conduct and record 30 minutes of ASE in one day lasting for 2-month, and at least 3 days a week. |
Participants were asked to conduct and record 30 minutes of ASE in one day lasting for 2-month, and at least 3 days a week.
A record sheet were sent to the participants in the first time, and the contact information of examiner were given as well.
The examiner will check the completion of exercise execution via phone every two to three days and visit participants to confirm the correctness of movement at least one time during the 2-month intervention period.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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cardiovascular system
Time Frame: 2 months
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Heart rate (HR), heart rate variability (HRV) to assess cardiac autonomic regulation.
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2 months
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cardiovascular system
Time Frame: 2 months
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blood pressue
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2 months
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cardiovascular system
Time Frame: 2 months
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Static photoplethysmography (PPG) signals were applied to measure low frequency oscillations of microvascular system, calculated as coefficient of variation (CV) of specific pulsation oscillation frequency, to assess vessel conditions for dynamic adaption in hemodynamics and biological signals.
In each frequency interval, cardiac activity intensity is represented in 0.6 to 2 Hz oscillation and respiratory activity is from 0.145 to 0.6 Hz, myogenic activity is from 0.052 to 0.145 Hz, neurogenic activity is from 0.021 to 0.052 Hz, and NO-dependent endothelial activity is microvessel oscillation from 0.0095 to 0.021 Hz.
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2 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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cerebrovascular system
Time Frame: 2 months
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Changes in oxygenated (HbO) and deoxygenated (Hb) hemoglobin concentrations measured from NIRs to assess brain activation in motor-related cortex.
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2 months
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balance ability
Time Frame: 2 months
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Ground reaction force, rate of force development (RFD)/body weight , and total time in five-time sit to stand test (5XSST) measured from forceplates to assess strength.
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2 months
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balance ability
Time Frame: 2 months
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Center of pressure of five-time sit to stand test (5XSST) measured from forceplates to assess dynamic stability.
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2 months
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Collaborators and Investigators
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 109-490
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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