A Pilot Study of Feasibility and Exploratory Study for a Definitive Randomised Controlled Trial of Foot-Ankle Versus Walking Exercises in Patients With Diabetes Mellitus: Effects on Neuropathy, Stress, and Quality of Life
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 108
- 试验地点
- 3
- 主要终点
- Feasibility: Recruitment Rate
研究概览
简要总结
This pilot feasibility and exploratory study, conducted to prepare for a definitive Randomized Controlled Trial (RCT), compares a structured foot-ankle exercise program with a walking exercise program in adults with Diabetes Mellitus (DM). The primary aim is to assess feasibility, including recruitment rate, retention, adherence, data completeness, acceptability, and adverse events, to inform procedures for the definitive RCT. The secondary (exploratory) aim is to obtain preliminary estimates of effects on Diabetic Peripheral Neuropathy (DPN), stress, and obstacles to Diabetes-Related Quality of Life (DR-QoL), Fasting Blood Glucose (FBG), Body Mass Index (BMI), blood pressure, and Ankle-Brachial Index (ABI).
Participants were allocated to three parallel arms for 12 weeks:
- Foot-ankle exercise (education plus printed materials; independent practice 2-3 sessions/day),
- Walking exercise (education plus printed materials; ≥150 minutes/week, ≥10 minutes/session, avoiding two consecutive non-exercise days), or
- Active control (education and printed materials).
Outcomes were assessed at baseline (day 0), week 6, and week 12. Analyses focus on feasibility metrics against pre-specified progression criteria and on hypothesis-generating estimates of within- and between-group change in neuropathy, stress, and obstacles to DR-QoL; the study is not powered for definitive efficacy.
Retrospective registration note: This study was registered retrospectively after participant enrolment had begun and data collection had been completed. This retrospective status is disclosed for transparency; exploratory outcome analyses are interpreted accordingly, and adverse events related to exercise were monitored and reported.
详细描述
Intervention Description Foot-Ankle Exercise Intervention The intervention is adapted from prior research and from exercises developed by the Indonesian Endocrinology Association. Participants receive brief DM and foot-ankle education, a leaflet, and supervised simulation to ensure correct technique. Independent practice is performed 2-3 sessions/day for 12 weeks. Target exercises ≥150 minutes/week.
The structured foot-ankle exercise program consists of 10 seated movements involving toe flexion, heel raises, circular ankle motions, knee extension with toe mobility, synchronized bilateral movements, and functional foot tasks (e.g., manipulating newspaper sheets).
Walking Exercise Intervention The walking program adapts protocols from previous studies. Participants receive DM and walking-exercise education plus a leaflet. They walk independently for ≥150 minutes per week (≥10 minutes/session) while avoiding two consecutive non-exercise days during the 12-week period.
Active Control Participants receive usual DM education (30 minutes) and a leaflet. No structured exercise program is provided.
All groups continue receiving standard public-health services. Weekly monitoring and adverse-event checks are performed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
Feasibility: Recruitment Rate
时间窗: From July 5, 2024 (first participant enrollment) to September 29, 2024 (final primary outcome data collection), over an actual period of approximately 12 weeks.
Participants enrolled per month per site and overall; eligibility and consent proportions
Feasibility: Retention Rate
时间窗: From July 5, 2024 (Baseline assessment) to September 29, 2024 (Week 12 follow-up), over an actual period of approximately 12 weeks.
Proportion of enrolled participants who complete follow-up assessments at Week 6 and Week 12.
Feasibility: Adherence to Assigned Intervention
时间窗: From July 5, 2024 (Week 0, baseline) to September 29, 2024 (Week 12 assessment), covering an actual intervention period of approximately 12 weeks.
Percentage of prescribed sessions achieved (foot-ankle and walking exercise) with ≥150 min/week and "no two consecutive non-exercise days"; proportion meeting adherence threshold (≥70%) across ≥12 weeks
Feasibility: Data Completeness
时间窗: From July 5, 2024 (Baseline) to September 29, 2024 (Week 12 follow-up), covering the period in which data completeness at Week 6 and Week 12 was assessed (12 weeks).
Proportion of participants with complete outcome data at Week 6 and Week 12 (per arm and overall).
Feasibility: Safety (Adverse Events)
时间窗: From July 5, 2024 (start of intervention at Week 0) to September 29, 2024 (Week 12 follow-up), covering an actual 12-week period of adverse event monitoring.
Exercise-related adverse events/serious adverse events (number and percentage)
Feasibility: Acceptability of the Intervention (Open-Ended Participant Feedback)
时间窗: From July 5, 2024 (start of intervention) to September 29, 2024 (Week 12), when acceptability feedback was collected, covering an actual period of approximately 12 weeks.
Open-ended questions elicit participants' messages/impressions, barriers, and difficulties during the intervention. Responses will be analysed with rapid thematic analysis using a pre-defined codebook; two independent coders will code all transcripts/notes, discrepancies resolved by discussion
Feasibility: Recruitment Rate
时间窗: From July 5, 2024 (first participant enrollment) to September 29, 2024 (final primary outcome data collection), over an actual period of approximately 12 weeks.
Participants enrolled per month per site and overall; eligibility and consent proportions
Feasibility: Retention Rate
时间窗: From July 5, 2024 (Baseline assessment) to September 29, 2024 (Week 12 follow-up), over an actual period of approximately 12 weeks.
Proportion of enrolled participants who complete follow-up assessments at Week 6 and Week 12.
Feasibility: Adherence to Assigned Intervention
时间窗: From July 5, 2024 (Week 0, baseline) to September 29, 2024 (Week 12 assessment), covering an actual intervention period of approximately 12 weeks.
Percentage of prescribed sessions achieved (foot-ankle and walking exercise) with ≥150 min/week and "no two consecutive non-exercise days"; proportion meeting adherence threshold (≥70%) across ≥12 weeks
Feasibility: Data Completeness
时间窗: From July 5, 2024 (Baseline) to September 29, 2024 (Week 12 follow-up), covering the period in which data completeness at Week 6 and Week 12 was assessed (12 weeks).
Proportion of participants with complete outcome data at Week 6 and Week 12 (per arm and overall).
Feasibility: Safety (Adverse Events)
时间窗: From July 5, 2024 (start of intervention at Week 0) to September 29, 2024 (Week 12 follow-up), covering an actual 12-week period of adverse event monitoring.
Exercise-related adverse events/serious adverse events (number and percentage)
Feasibility: Acceptability of the Intervention (Open-Ended Participant Feedback)
时间窗: From July 5, 2024 (start of intervention) to September 29, 2024 (Week 12), when acceptability feedback was collected, covering an actual period of approximately 12 weeks.
Open-ended questions elicit participants' messages/impressions, barriers, and difficulties during the intervention. Responses will be analysed with rapid thematic analysis using a pre-defined codebook; two independent coders will code all transcripts/notes, discrepancies resolved by discussion
次要结局
- Diabetic Peripeheral Neuropathy (DPN)(From July 5, 2024 (Baseline) to September 29, 2024 (Week 12), during which DPN was assessed at Baseline, Week 6, and Week 12; covering an actual 12-week period.)
- Stress(From July 5, 2024 (Baseline) to September 29, 2024 (Week 12), during which stress was assessed at Baseline, Week 6, and Week 12 over an actual 12-week period.)
- Obstacles to Diabetes Related Quality of Life (DR-QoL)(From July 5, 2024 (Baseline) to September 29, 2024 (Week 12), during which DR-QoL (DOQ-30) was assessed at Baseline, Week 6, and Week 12 over an actual 12-week period.)
- Fasting Blood Glucose (FBG)(From July 5, 2024 (Baseline) to September 29, 2024 (Week 12), during which fasting blood glucose was measured at Baseline, Week 6, and Week 12 over an actual 12-week period.)
- Blood Pressure(From July 5, 2024 (Baseline) to September 29, 2024 (Week 12), during which blood pressure was measured at Baseline, Week 6, and Week 12 over an actual 12-week period.)
- Body Mass Index (BMI)(From July 5, 2024 (Baseline) to September 29, 2024 (Week 12), during which BMI was measured at Baseline, Week 6, and Week 12 over an actual 12-week period.)
- Ankle-Brachial Index (ABI)(From July 5, 2024 (Baseline) to September 29, 2024 (Week 12), during which ABI was measured at Baseline, Week 6, and Week 12 over an actual 12-week period.)
- Diabetic Peripeheral Neuropathy (DPN)(From July 5, 2024 (Baseline) to September 29, 2024 (Week 12), during which DPN was assessed at Baseline, Week 6, and Week 12; covering an actual 12-week period.)
- Stress(From July 5, 2024 (Baseline) to September 29, 2024 (Week 12), during which stress was assessed at Baseline, Week 6, and Week 12 over an actual 12-week period.)
- Obstacles to Diabetes Related Quality of Life (DR-QoL)(From July 5, 2024 (Baseline) to September 29, 2024 (Week 12), during which DR-QoL (DOQ-30) was assessed at Baseline, Week 6, and Week 12 over an actual 12-week period.)
- Fasting Blood Glucose (FBG)(From July 5, 2024 (Baseline) to September 29, 2024 (Week 12), during which fasting blood glucose was measured at Baseline, Week 6, and Week 12 over an actual 12-week period.)
- Blood Pressure(From July 5, 2024 (Baseline) to September 29, 2024 (Week 12), during which blood pressure was measured at Baseline, Week 6, and Week 12 over an actual 12-week period.)
- Body Mass Index (BMI)(From July 5, 2024 (Baseline) to September 29, 2024 (Week 12), during which BMI was measured at Baseline, Week 6, and Week 12 over an actual 12-week period.)
- Ankle-Brachial Index (ABI)(From July 5, 2024 (Baseline) to September 29, 2024 (Week 12), during which ABI was measured at Baseline, Week 6, and Week 12 over an actual 12-week period.)
研究者
Siti Fadlilah
Principal Investigator
Taipei Medical University