A pilot study to assess the efficacy of Tai Chi for Type 1 Diabetes

Authors
Category Primary study
Registry of TrialsANZCTR
Year 2016
INTERVENTION: This is a quasi randomized controlled trial. Participants with type 1 diabetes will be randomly allocated to the Tai Chi, or the usual medical care alone control group using a computer‐generated randomization schedulebased on recruitment date. The recruitment of control group participants will be conducted after completion of recruitment of Tai Chi group participants. In addition to usual care, participants in the intervention groups (Group A) will have two supervised instructor‐led group training sessions per week during the first three months of intervention; followed by self‐led training during the remaining three months. Tai Chi group participants will receive a DVD/video tape demonstrating the Tai Chi program and will be encouraged to practice at home on days when they do not attend group sessions. Each Tai Chi session will last approximately 1 to 1.5 hours with 30 minutes warm up, 30 minutes practice, and 6 to 30 minutes cool down. During the second three months of follow up, Tai Chi group participants will have ‘free choice’ (‘self‐led’ training) and are encouraged to organize their own group training, or practice at home. All participants will continue to receive medical usual care from their GPs throughout the study and receive a monthly phone call to encourage them to maintain their usual care and reduce drop‐out from the study. The control group (Group B) will participate in the study during the first 3 months and attend baseline and 3 months assessments. The control group will be offered the Tai Chi program at the end of the study. . CONDITION: Type 1 Diabetes PRIMARY OUTCOME: *Depressive symptoms using CESD Depression Scale (CESD 10) *HbA1c (to give an indication of average blood glucose over the preceding 2 ‐ 3 ; months). SECONDARY OUTCOME: Blood pressure: assessed by blood pressure monitor. Body mass index: weight and height are assessed by weight and measurement tape. Changes in medication, in particular total daily dose of insulin, dose of BP lowering therapy, lipid lowering therapy and depression (using questionnaire). This is a composite secondary outcome using a questionnaire named "Changes in Medication" which is designed specifically for this study. Health related quality of life (using SF36). Leg strength using a chair‐stand test (number of stands completed in 30 seconds) modified from the US Senior Fitness Test. Lipids: assessed by blood samples. Physical activity using a one week recall questionnaire adapted from the Active Australia Survey. The items have demonstrated acceptable test‐retest reliability. Waist circumference: assessed by measurement tape. INCLUSION CRITERIA: type 1 diabetes with HbA1c of 7.5 ‐ 10% on stable insulin therapy; aged 18 ‐ 70 years; no health or injury problems that would prevent doing the exercises; able to attend intervention sessions 2 times per week for 12 weeks and 'self‐led' training for a further 12 weeks; and living in Brisbane.
Epistemonikos ID: c85a9065a4c10091ac018ae4bad75b49342e93d7
First added on: Aug 25, 2024