Diabetes Mellitus Diabetic Peripheral Neuropathy Diabetic Foot Diabetes Diabetes (DM) Diabetic Peripheral Neuropathy Stress Quality of life Fasting blood glucose Body mass index Blood pressure Ankle-brachial index Diabetes mellitus Exercise Waliking exercise Foot-ankle exercise Study Design
Conditions
Interventions
Foot-ankle exercise group received usual care provided by the public health center and intervention via health education and leaflets about foot-ankle exercise. At the first meeting, participants lear
Foot-ankle exercise group,Walking exercise group,Control Group
Sponsors
Principal Investigator
Eligibility
Sex/Gender
All
Age
20 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1 People with type 2 diabetes 2 Aged 20-70 years 3 Diagnosed with DM for at least 1 year 4 Can walk without assistance 5 Able to communicate well 6 Can read and write 7 Willing to be a respondent
Exclusion criteria
Exclusion criteria: 1 Has a history of leg amputation 2 Have a diagnosis of heart failure, kidney failure, pulmonary TB, and stroke 3 Patients with a history or under-treatment of mental disorders 4 DM patients with foot ulcers 5 DM patients with fractures or difficulty using the lower extremities
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Recruitment Rate From first site-open to last enrolment. Participants enrolled per month per site and overall; eligibility and consent proportions,Retention baseline, 6 weeks (T1), 12 weeks (T2) Proportion with complete outcome data at T1 and T2 (per arm/overall),Adherence to Assigned Exercise 12 weeks Percentage of prescribed sessions achieved foot-ankle or walking min 150 min per week with no two consecutive non-exercise days; proportion meeting adherence threshold (min 70),Data Completeness T0, T1, T2 Proportion of non-missing values for exploratory outcomes,Adverse Events Baseline to 12 week Exercise-related adverse events/serious adverse events (number and percentage),Acceptability of the Intervention (Open-Ended Participant Feedback) 12 weeks Open-ended questions elicit participants messages/impressions, barriers, and difficulties during the intervention. | — |
Secondary
| Measure | Time frame |
|---|---|
| Diabetic peripeheral neuropathy (DPN) Baseline (before intervention/0 week), at 6-weeks and 12-weeks DPN measured by MNSI, Foot sensation will be measured using Semmes Weinstein Monofilament 10g, Foot vibration measurement using Tunning Fork 128Hz,Stress of People with Diabetes Mellitus Baseline (before intervention/0 week), at 6-weeks and 12-weeks Stress will be measured using the Indonesian version of the Problem Areas in Diabetes (PAID) questionnaire,Obstacles to Diabeter Related Quality of Life (DR-QoL) Baseline (before intervention/0 week), at 6-weeks and 12-weeks Obstacles to DR-QoL measured using 8 domains of the Indonesian version of the Diabetes Obstacles Questionnaire Short Version (DOQ-30) which we have previously tested for validity and reliability. ,Fasting Blood Glucose (FBG) of People with Diabetes Mellitus Baseline (before intervention/0 week), at 6-weeks and 12-weeks] FBG were measured using venous blood after the respondent fasted for at least 8 hours.,Blood Pressure of People with Diabetes Mellitus Baseline (before intervention/0 week), at 6-weeks and 12-weeks Blood pressure will be measured using a digital tensimeter, ,Body Mass Index Baseline (before intervention/0 week), at 6-weeks and 12-weeks Body weight was measured using digital scales, and height using height-measuring devices. BMI is calculated using the - Page 7 of 18 [DRAFT] -formula body weight (kg) divided by height2 (m2),Ankle-Brachial Index (ABI) Baseline (before intervention/0 week), at 6-weeks and 12-weeks ABI measurements carried out using continuous-wave Doppler ultrasound using SOPs prepared previously | — |
Countries
Indonesia
Contacts
Public ContactSiti Fadlilah
Taipei Medical University
Outcome results
None listed