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Effects of Qigong on Type 2 Diabetic Patients

This study has been completed.
Sponsor:
Collaborator:
Seattle Foundation
Information provided by:
Bastyr University
ClinicalTrials.gov Identifier:
NCT00885846
First received: February 5, 2009
Last updated: April 27, 2009
Last verified: April 2009
History of Changes
Results First Received: February 5, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Diabetes Mellitus, Type 2
Interventions: Other: Qigong therapy
Other: Progressive resistance training

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participant recruitment for cohort 1: August 2007. Participant recruitment for cohort 2: February 2008. Place of recruitment: Bastyr University Research Institute.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
The second cohort was necessary to achieve desired sample size.

Reporting Groups
  Description
Qigong Therapy Participants practiced Qigong at least three times per week for 30 minute sessions, including once a week with a certified instructor, for 12 weeks.
Progressive Resistance Training (PRT) Participants practiced PRT at least three times per week for 30 minute sessions, including once a week with a certified instructor, for 12 weeks.
Non-treated Control Participants were asked to maintain their conventional diabetes care for the duration of the study (12 weeks).

Participant Flow:   Overall Study
    Qigong Therapy     Progressive Resistance Training (PRT)     Non-treated Control  
STARTED     11 [1]   11 [2]   10 [3]
COMPLETED     9 [4]   6 [5]   8 [3]
NOT COMPLETED     2     5     2  
Withdrawal by Subject                 2                 5                 2  
[1] Cohort 1 = 5 Cohort 2 = 6
[2] Cohort 1 = 6 Cohort 2 = 5
[3] Cohort 1 = 4 Cohort 2 = 6
[4] Cohort 1 = 3 Cohort 2 = 6
[5] Cohort 1 = 1 Cohort 2 = 5



  Baseline Characteristics
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Reporting Groups
  Description
Qigong Therapy Participants practiced Qigong at least three times per week for 30 minute sessions, including once a week with a certified instructor, for 12 weeks.
Progressive Resistance Training (PRT) Participants practiced PRT at least three times per week for 30 minute sessions, including once a week with a certified instructor, for 12 weeks.
Non-treated Control Participants were asked to maintain their conventional diabetes care for the duration of the study (12 weeks).
Total Total of all reporting groups

Baseline Measures
    Qigong Therapy     Progressive Resistance Training (PRT)     Non-treated Control     Total  
Number of Participants  
[units: participants]
 		  11     11     10     32  
Age  
[units: participants]
 		       
<=18 years     0     0     0     0  
Between 18 and 65 years     11     9     7     27  
>=65 years     0     2     3     5  
Age  
[units: years]
Mean ± Standard Deviation 		  56.2  ± 7.5     52.8  ± 9.9     60.2  ± 6.3     56.3  ± 8.1  
Gender  
[units: participants]
 		       
Female     7     6     6     19  
Male     4     5     4     13  
Region of Enrollment  
[units: participants]
 		       
United States     11     11     10     32  



  Outcome Measures

1.  Primary:   Fasting Blood Glucose   [ Time Frame: Week 0 (baseline) and week 12 (final) ]
  Show Outcome Measure 1

2.  Secondary:   Fasting C-peptide   [ Time Frame: weeks 0 and 12 ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

3.  Secondary:   Fasting Insulin   [ Time Frame: weeks 0 and 12 ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

4.  Secondary:   Perceived Stress Scale (PSS)   [ Time Frame: weeks 0 and 12 ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

5.  Secondary:   Beck's Depression Inventory (BDI)   [ Time Frame: weeks 0 and 12 ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

6.  Secondary:   HOMA-IR Index   [ Time Frame: weeks 0 and 12 ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

7.  Secondary:   Fasting Cortisol   [ Time Frame: Weeks 0 and 12 ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events
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  Other Adverse Events
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No Other Adverse Events Entered.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Limitations to this study include high withdrawal rate from PRT group, especially during the first cohort. Also, participants from both Qigong and PRT group changed or discontinued medications. Consequently, their results were excluded from analysis.  


Results Point of Contact:  
Name/Title: Guan-Cheng Sun, PhD
Organization: Bastyr University
phone: 425-602-3389
e-mail: gsun@bastyr.edu


Publications:

Publications automatically indexed to this study:


Responsible Party: Guan-Cheng Sun, PhD, Bastyr University
ClinicalTrials.gov Identifier: NCT00885846     History of Changes
Other Study ID Numbers: H77B11
Study First Received: February 5, 2009
Results First Received: February 5, 2009
Last Updated: April 27, 2009
Health Authority: United States: Institutional Review Board