Working…
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Effects of Qigong on Type 2 Diabetic Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00885846
Recruitment Status : Completed
First Posted : April 22, 2009
Results First Posted : April 22, 2009
Last Update Posted : November 16, 2015
Sponsor:
Collaborator:
Seattle Foundation
Information provided by (Responsible Party):
Bastyr University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Diabetes Mellitus, Type 2
Interventions Other: Qigong therapy
Other: Progressive resistance training
Enrollment 32
Recruitment Details Participant recruitment for cohort 1: August 2007. Participant recruitment for cohort 2: February 2008. Place of recruitment: Bastyr University Research Institute.
Pre-assignment Details The second cohort was necessary to achieve desired sample size.
Arm/Group Title Qigong Therapy Progressive Resistance Training (PRT) Non-treated Control
Hide Arm/Group Description Participants practiced Qigong at least three times per week for 30 minute sessions, including once a week with a certified instructor, for 12 weeks. Participants practiced PRT at least three times per week for 30 minute sessions, including once a week with a certified instructor, for 12 weeks. Participants were asked to maintain their conventional diabetes care for the duration of the study (12 weeks).
Period Title: Overall Study
Started 11 [1] 11 [2] 10 [3]
Completed 9 [4] 6 [5] 8 [3]
Not Completed 2 5 2
Reason Not Completed
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
Arm/Group Title Qigong Therapy Progressive Resistance Training (PRT) Non-treated Control Total
Hide Arm/Group Description Participants practiced Qigong at least three times per week for 30 minute sessions, including once a week with a certified instructor, for 12 weeks. Participants practiced PRT at least three times per week for 30 minute sessions, including once a week with a certified instructor, for 12 weeks. Participants were asked to maintain their conventional diabetes care for the duration of the study (12 weeks). Total of all reporting groups
Overall Number of Baseline Participants 11 11 10 32
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants 11 participants 10 participants 32 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0.0
Between 18 and 65 years
11
 100.0%
9
  81.8%
7
  70.0%
27.0
>=65 years
0
   0.0%
2
  18.2%
3
  30.0%
5.0
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 11 participants 11 participants 10 participants 32 participants
56.2  (7.5) 52.8  (9.9) 60.2  (6.3) 56.3  (8.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants 11 participants 10 participants 32 participants
Female
7
  63.6%
6
  54.5%
6
  60.0%
19.0
Male
4
  36.4%
5
  45.5%
4
  40.0%
13.0
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 11 participants 11 participants 10 participants 32 participants
11 11 10 32
1.Primary Outcome
Title Fasting Blood Glucose
Hide Description [Not Specified]
Time Frame Week 0 (baseline) and week 12 (final)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis performed per protocol. Participants excluded from analysis for changing or discontinuing medication during intervention.
Arm/Group Title Qigong Therapy Progressive Resistance Training (PRT) Non-treated Control
Hide Arm/Group Description:
Participants practiced Qigong at least three times per week for 30 minute sessions, including once a week with a certified instructor, for 12 weeks.
Participants practiced PRT at least three times per week for 30 minute sessions, including once a week with a certified instructor, for 12 weeks.
Participants were asked to maintain their conventional diabetes care for the duration of the study (12 weeks).
Overall Number of Participants Analyzed 7 5 8
Mean (Standard Deviation)
Unit of Measure: mg/dL
week 0 (baseline) 184.9  (35.3) 143.8  (35.0) 156.4  (36.6)
week 12 (final) 161.9  (40.5) 154.0  (44.7) 168.4  (49.1)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Qigong Therapy, Progressive Resistance Training (PRT), Non-treated Control
Comments Power analysis suggested 27 participants, 9 in each group.
Type of Statistical Test Non-Inferiority or Equivalence
Comments Regression analysis performed for equal variance at baseline.
Statistical Test of Hypothesis P-Value 0.664
Comments [Not Specified]
Method Repeated ANOVA
Comments degrees of freedom = 2
2.Secondary Outcome
Title Fasting C-peptide
Hide Description [Not Specified]
Time Frame weeks 0 and 12
Outcome Measure Data Not Reported
3.Secondary Outcome
Title Fasting Insulin
Hide Description [Not Specified]
Time Frame weeks 0 and 12
Outcome Measure Data Not Reported
4.Secondary Outcome
Title Perceived Stress Scale (PSS)
Hide Description [Not Specified]
Time Frame weeks 0 and 12
Outcome Measure Data Not Reported
5.Secondary Outcome
Title Beck's Depression Inventory (BDI)
Hide Description [Not Specified]
Time Frame weeks 0 and 12
Outcome Measure Data Not Reported
6.Secondary Outcome
Title HOMA-IR Index
Hide Description [Not Specified]
Time Frame weeks 0 and 12
Outcome Measure Data Not Reported
7.Secondary Outcome
Title Fasting Cortisol
Hide Description [Not Specified]
Time Frame Weeks 0 and 12
Outcome Measure Data Not Reported
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Qigong Therapy Progressive Resistance Training Control
Hide Arm/Group Description Qigong therapy: For 12 weeks, subjects in Qigong therapy group are to follow a disciplined regular practice, 3 times a week for about 30 minutes, including once a week with a certified instructor to lead and check the correctness of their practice. Progressive resistance training: For 12 weeks, subjects in the PRT group are to follow a disciplined regular practice, 3 times a week for about 30 minutes, including once a week with a certified instructor to lead and check the correctness of their practice. Wait list group; no activity at this arm. On list to start Qigong
All-Cause Mortality
Qigong Therapy Progressive Resistance Training Control
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Hide Serious Adverse Events
Qigong Therapy Progressive Resistance Training Control
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/11 (0.00%)   0/11 (0.00%)   0/10 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Qigong Therapy Progressive Resistance Training Control
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/11 (0.00%)   0/11 (0.00%)   0/10 (0.00%) 
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.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Guan-Cheng Sun, PhD
Organization: Bastyr University
Phone: 425-602-3389
EMail: gsun@bastyr.edu
Layout table for additonal information
Responsible Party: Bastyr University
ClinicalTrials.gov Identifier: NCT00885846    
Other Study ID Numbers: H77B11
First Submitted: February 5, 2009
First Posted: April 22, 2009
Results First Submitted: February 5, 2009
Results First Posted: April 22, 2009
Last Update Posted: November 16, 2015