Trial Outcomes & Findings for Effects of Qigong on Type 2 Diabetic Patients (NCT NCT00885846)

NCT ID: NCT00885846

Last Updated: 2015-11-16

Results Overview

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 32 participants
• Primary outcome timeframe: Week 0 (baseline) and week 12 (final)
• Results posted on: 2015-11-16

Participant Flow

Participant recruitment for cohort 1: August 2007. Participant recruitment for cohort 2: February 2008. Place of recruitment: Bastyr University Research Institute.

The second cohort was necessary to achieve desired sample size.

Participant milestones

Measure	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).
Overall Study STARTED	11	11	10
Overall Study COMPLETED	9	6	8
Overall Study NOT COMPLETED	2	5	2

Reasons for withdrawal

Measure	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).
Overall Study Withdrawal by Subject	2	5	2

Baseline Characteristics

Effects of Qigong on Type 2 Diabetic Patients

Baseline characteristics by cohort

Measure	Qigong Therapy n=11 Participants 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) n=11 Participants 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 n=10 Participants Participants were asked to maintain their conventional diabetes care for the duration of the study (12 weeks).	Total n=32 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0.0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	11 Participants n=5 Participants	9 Participants n=7 Participants	7 Participants n=5 Participants	27.0 Participants n=4 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants	5.0 Participants n=4 Participants
Age, Continuous	56.2 years STANDARD_DEVIATION 7.5 • n=5 Participants	52.8 years STANDARD_DEVIATION 9.9 • n=7 Participants	60.2 years STANDARD_DEVIATION 6.3 • n=5 Participants	56.3 years STANDARD_DEVIATION 8.1 • n=4 Participants
Sex: Female, Male Female	7 Participants n=5 Participants	6 Participants n=7 Participants	6 Participants n=5 Participants	19.0 Participants n=4 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	5 Participants n=7 Participants	4 Participants n=5 Participants	13.0 Participants n=4 Participants
Region of Enrollment United States	11 participants n=5 Participants	11 participants n=7 Participants	10 participants n=5 Participants	32.0 participants n=4 Participants

PRIMARY outcome

Timeframe: Week 0 (baseline) and week 12 (final)

Population: Analysis performed per protocol. Participants excluded from analysis for changing or discontinuing medication during intervention.

Outcome measures

Measure	Qigong Therapy n=7 Participants 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) n=5 Participants 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 n=8 Participants Participants were asked to maintain their conventional diabetes care for the duration of the study (12 weeks).
Fasting Blood Glucose week 0 (baseline)	184.9 mg/dL Standard Deviation 35.3	143.8 mg/dL Standard Deviation 35.0	156.4 mg/dL Standard Deviation 36.6
Fasting Blood Glucose week 12 (final)	161.9 mg/dL Standard Deviation 40.5	154.0 mg/dL Standard Deviation 44.7	168.4 mg/dL Standard Deviation 49.1

SECONDARY outcome

Timeframe: weeks 0 and 12

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: weeks 0 and 12

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: weeks 0 and 12

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: weeks 0 and 12

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: weeks 0 and 12

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Weeks 0 and 12

Outcome measures

Outcome data not reported

Adverse Events

Qigong Therapy

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Progressive Resistance Training

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Guan-Cheng Sun, PhD

Bastyr University

Phone: 425-602-3389

Email: gsun@bastyr.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place