Health benefits of a COMmunity-based WALKing programme in Bahraini adults with type 2 diabetes

• Register: ISRCTN
• Last refreshed on: 17 October 2016
• Main ID: ISRCTN49941929
• Date of registration: 21/06/2011
• Prospective Registration: No
• Primary sponsor: Arabian Gulf University (Bahrain)
• Public title: Health benefits of a COMmunity-based WALKing programme in Bahraini adults with type 2 diabetes
• Scientific title: Efficacy of a COMmunity-based WALKing programme with or without a pedometer on markers of glucose control, cardio-respiratory fitness and lung inflammation in Bahraini adults with type 2 diabetes: a pilot randomised controlled trial
• Date of first enrolment: 10/01/2011
• Target sample size: 45
• Recruitment status: Completed
• URL: http://isrctn.com/ISRCTN49941929
• Study type: Interventional
• Study design: Pilot randomised controlled trial (Quality of life)

Countries of recruitment

Bahrain

Contacts

• Name: Usha Sachdeva

Key inclusion & exclusion criteria

Inclusion criteria: 1. Bahraini adults (aged 24-60 years) with type 2 diabetes (as defined by the American Diabetic Association, 1997) for more than 6 months
2. A baseline haemoglobin A1c of 6.6% to 9.9%.
Exclusion criteria: 1. Current insulin therapy
2. Participation in exercise two or more times per week for more than or equal to 20 minutes/session during the previous 6 months
3. Changes during the previous 2 months in oral hypoglycaemic, antihypertensive or lipid-lowering agents and body weight (more than or equal to 5%)
4. Serum creatinine level of 200 µmol/L or greater
5. Proteinuria greater than 1g/d
6. Blood pressure greater than 160/95 mm Hg
7. Restrictions in physical activity because of disease
8. Presence of other medical conditions that make participation inadvisable

Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Type 2 diabetes
Nutritional, Metabolic, Endocrine
Non-insulin-dependent diabetes mellitus

Intervention(s)

Following baseline measurements, patients will be randomly assigned to one of three groups (n=15 each):
1. Standard diabetes treatment alone (i.e. control)
2. Standard treatment and two one-hour sessions of group-based physical activity education, each delivered at six week intervals, to promote walking
3. Standard treatment, a pedometer and two one-hour sessions of group-based physical activity education, each delivered at six week intervals, to promote steps-per-day goals.

Contact details:
Principal Investigator:
U. Sachdeva MD, PhD
Department of Physiology
Arabian Gulf University
P. O. Box 22979, Manama
Kingdom of Bahrain

Co-Investigators: E. Rajab PhD MCSP2, M. M. F. Subhan PhD1, P. Trinidad MD, MRS, PT2
Department of Physiology
Arabian Gulf University
P. O. Box 22979, Manama
Kingdom of Bahrain

The numbers after the qualifications of each author refer to their home institution.
1= Arabian Gulf University
2= Ahlia University

Primary Outcome(s)

Change in haemoglobin A1c between baseline and the end of the 12-week programme

Secondary Outcome(s)

1. Pedometry (steps/day)
2. Physical activity level (International Physical Activity Questionnaire)
3. Fraction of nitric oxide in exhaled air (FeNO) to evalaute cardiorespiratory fitness
4. Body Mass Index
5. Percent body fat
6. Blood glucose
Assessed at baseline, 6 and 12 weeks

Secondary ID(s)

N/A

Source(s) of Monetary Support

Arabian Gulf University (Bahrain) (research grant No. 72), Ahlia University (Bahrain)

Secondary Sponsor(s)

Ahlia University (Bahrain)