The Effectiveness of Foot-Ankle Exercise and Walking Exercise on Foot Neuropathy, Stress, Quality of Life, Blood Sugar Markers, Blood Pressure, Ankle-Brachial Index, and BMI Among Diabetes Mellitus Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 375
- 试验地点
- 10
- 主要终点
- Quality of Life of People with Diabetes Mellitus
研究概览
简要总结
The primary purpose of this study is to determine the effectiveness of foot-ankle exercise and walking exercise on foot neuropathy, stress, and quality of life (QoL) among people with diabetes mellitus (PWDM). At the same time, the secondary purpose of this study is to determine the effectiveness of foot-ankle exercise and walking exercise on body mass index (BMI), fasting blood glucose (FBG), blood pressure (BP), and ankle-brachial index (ABI) among PWDM at baseline (before intervention/0 week), at 6-weeks and 12-weeks.
The research questions in this study include the following:
- Is foot-ankle exercise effective for foot neuropathy, stress, QoL, BMI, FBG, BP, and ABI for PWDM?
- Is walking exercise effective for foot neuropathy, stress, QoL, BMI, FBG, BP, and ABI for PWDM?
- Are there any differences in the mean scores of foot neuropathy, stress, QoL, BMI, FBG, BP, and ABI of PWDM within and between the foot-ankle exercise, walking exercise and control group at baseline, 6 weeks, and 12 weeks?
- Are there any mediators/moderators effect of BMI, FBG, blood pressure, ABI, and stress for influencing foot exercise and walking exercise interventions on foot neuropathy and QoL for PWDM?
Participants in the foot-ankle exercise group will be given health education about DM and foot-ankle exercise, as well as leaflets and videos. Participants will be taught how to practice foot-ankle exercises before the instructor. Afterwards, participants will practice foot-ankle exercises independently without supervision for 2-3 sessions every day for 12 weeks. Participants in the walking exercise group will be given health education about DM, walking exercises and leaflets. Participants will practice walking exercises independently without supervision for 12 weeks. Participants are advised to do walking exercises with a minimum duration of 10 minutes for each session and 150 minutes/week. Two consecutive days without walking exercise are not allowed. Participants in the control groups will be treated as active control and given health education on general DM topics and leaflets. All groups received usual care according to standards provided by public health services. Researchers will compare the groups to see the effect of the interventions on foot neuropathy, stress, QoL, BMI, FBG, BP, and ABI at three different time points: at baseline, 6 weeks, and 12 weeks.
详细描述
Intervention Development
This study focused on foot-ankle exercises modified from previous research and adapted to exercises developed by the Indonesian Endocrinology Association. Providing health education about DM in general and foot-ankle exercise is intended to increase participants' basic knowledge about DM and the importance of foot-ankle exercises. Foot-ankle exercise simulation and practice aim to ensure participants can do it well and independently. The leaflet contains the material presented during health education and is given to participants. A video was made containing the steps to do foot-ankle exercises. Researchers will upload videos of the foot-ankle exercises to YouTube. Participants will be given the video in soft file form and informed that they can access it via the researcher's YouTube channel. Walking exercises in this study adapted and modified from previous research. Providing health education about DM in general and walking exercises is intended to increase participants' basic knowledge about DM and the importance of walking exercise exercises. The leaflet contains the material presented during health education and is given to participants in walking exercise groups.
Content Validity
The content validity test in this study aims to validate the intervention procedures used during the research process. The details are: detail intervention of foot-ankle exercise and walking exercise, health education materials and leaflets for the control group, foot-ankle exercise groups, and walking exercise groups, videos of foot ankle exercises, standard operational procedures for measuring foot sensation and foot vibration, height and weight, BP, and ABI. The criteria for Experts: 1) Willing to be involved in the content validity study, 2) Doctor/nurse, 3) Have experience working in the clinical or research area on the topic of diabetes mellitus for more than 5 years. In this study, six experts are needed to achieve a content validation index (CVI) satisfaction of 0.83. Researchers will send formal invitations via email to experts. The files include an application letter, a cover letter containing the research objectives, expert panel criteria, intervention procedures to be assessed, and an assessment sheet. Assessment of each item uses a 1-4 Likert scale. Item with score <3 will be asked to provide comments or suggestions to help further refine the intervention protocol. Researchers will use item-level CVI (I-CVI) and the scale-level (S-CVI). The CVI value is satisfactory if I-CVI ≥0.80 and S-CVI ≥0.83. Items with a low CVI value will be revised according to the comments and suggestions of experts until the CVI value becomes satisfactory.
Participants Recruitment Process
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
盲法说明
Data collectors who assess the outcomes and statistician who analyse the data are blinded.
入排标准
- 年龄范围
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •People with type 2 diabetes
- •Aged 20-70 years
- •Diagnosed with DM for at least 1 year
- •Can walk without assistance
- •Able to communicate well
- •Can read and write
- •Willing to be a respondent
排除标准
- •Has a history of leg amputation
- •Have a diagnosis of heart failure, kidney failure, pulmonary TB, stroke
- •Patients with a history or under-treatment of mental disorders
- •DM patients with foot ulcers
- •DM patients with fractures or difficulty using the lower extremities
结局指标
主要结局
Quality of Life of People with Diabetes Mellitus
时间窗: Baseline (before intervention/0 week), at 6-weeks and 12-weeks
QoL will be measured using the Indonesian version of the Diabetes Obstacles Questionnaire Short Version (DOQ-30) which we have previously tested for validity and reliability. DOQ-30 Bahasa Indonesia has nine factors and a 5-point Likert scale with answer options never (5), almost never (4), sometimes (3), often (2), and always (1). The total score ranges 30-150, with a higher score indicating a better QoL. Factors in the DOQ-30 are relationships with medical professionals, support from friends and family, knowledge of the disease, lifestyle changes, exercising, self-monitoring, uncertainty about a consultation, medication, and insulin use. EFA and CFA analysis showed valid and reliable results; Cronbach's alpha for all items was 0.930, and individual factors ranged from 0.730 to 0.848. The test-retest results were excellent (with interclass correlation coefficients of 0.910 to 0.973). The CFA test obtained RMSEA=0.057 and SRMR=0.067, indicating a good model fit.
Foot Neuropathy of People with Diabetes Mellitus
时间窗: Baseline (before intervention/0 week), at 6-weeks and 12-weeks
Foot neuropathy will be measured by MNSI. MNSI consist of MNSI-A (questionnaire) and MNSI-B (physical examination). Foot sensation will be measured using Semmes Weinstein Monofilament 10g. Participants will be given a stimulus for 1.5-2 seconds at 10 points on both legs. The locations are heel, dorsal surface of the foot (between the bases of 1st-2nd toes), toes (1st, 3rd, and 5th), metatarsal heads (1st, 3rd, 5th), and midfoot (medial and lateral). The results range from 0-10. Foot vibration measurement using Tunning Fork 128Hz. The vibrating TF will be placed on each leg in 4 locations (medial, malleolus, great toe, fifth toe). Participants were asked to feel the vibrations and signal by raising their hands if they were no longer felt. The observer will record the time from when the participant feels the initial until it disappears. The results consist of whether the participant felt the vibration or not (0-4) and the length of time participants can feel the vibration (in seconds).
Stress of People with Diabetes Mellitus
时间窗: 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. This study uses PAID Bahasa Indonesia, which we have previously tested for validity and reliability. PAID Bahasa Indonesia has 20 items and three factors, with a loading factor of 0.349-0.779 for each item. The results of exploratory factor analysis (EFA) and confirmatory factor analysis (CFA) show valid and reliable results. Cronbach's alpha for all items is 0.858, inter-class correlation 0.938, RMSEA=0.058, and SRMR=0.062. PAID Bahasa Indonesia consist of five answer choices using a Likert scale (0-4). The answer choice scores used were 'not a problem' (0), 'minor problem' (1), 'moderate problem' (2), 'somewhat serious problem' (3), and 'serious problem' (4). The total score ranged 0-80, with a higher score indicating greater stress.
次要结局
- Fasting Blood Glucose (FBG) of People with Diabetes Mellitus(Baseline (before intervention/0 week), at 6-weeks and 12-weeks)
- Blood Pressure of People with Diabetes Mellitus(Baseline (before intervention/0 week), at 6-weeks and 12-weeks)
- Body Mass Index of People with Diabetes Mellitus(Baseline (before intervention/0 week), at 6-weeks and 12-weeks)
- Ankle-Brachial Index (ABI) of People with Diabetes Mellitus(Baseline (before intervention/0 week), at 6-weeks and 12-weeks)
- Adherence Participants in Experimental Group(12-weeks)
研究者
Siti Fadlilah
Principal Investigator
Taipei Medical University