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临床试验/NCT03238222
NCT03238222Unknown不适用

A Brief Physiotherapist-led Behaviour Change Intervention to Facilitate Walking in Older People With Peripheral Arterial Disease: a Randomised Controlled Trial

Guy's and St Thomas' NHS Foundation Trust9 个研究点 分布在 1 个国家目标入组 192 人开始时间: 2017年11月10日最近更新:
适应症

试验速览

阶段
不适用
入组人数
192
试验地点
9
主要终点
6 Minute Walk Distance

研究概览

简要总结

Peripheral arterial disease can cause leg pain or discomfort (called intermittent claudication (IC)), which limits the ability to walk and carry out everyday activities. Lifestyle changes, like increasing walking, can lead to improvements, but can be a challenge to begin and then continue. The aim of this study is to investigate if a physiotherapist-led, behaviour change treatment effects walking in people with IC. The treatment is designed to build an understanding of IC and walking exercise and help individuals develop strategies to increase regular walking. The trial will recruit 192 adults (aged 50 years and over) with IC. All participants will visit King's College London or their local hospital to complete two short walking tests and answer questionnaires about their daily activities, beliefs about their symptoms and treatment, quality of life and the costs of having IC.

Participants will then be randomly assigned to receive either the new treatment or continue with their usual NHS care. The new treatment involves two 60-minute face-to-face sessions (at the participant's home or local hospital) and two 20-minute telephone calls with a physiotherapist who will discuss participants' understanding and beliefs about IC, walking and help participants to set goals and plans to increase walking over 12 weeks. Participants will be provided with a step counter (pedometer) and walking record.

After 12 weeks, all participants will attend a second appointment where they will repeat the walking tests and fill out another set of questionnaires. A final set of questionnaires will be completed by all participants after 6 months (by post or electronically). Some participants will be invited to provide feedback on their experience of the treatment and trial by telephone or a face-to-face interview with a researcher.

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)

入排标准

年龄范围
50 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • ≥50 years of age;
  • established PAD (Ankle Brachial Pressure Index ≤0.90 and/or radiographic evidence or clinician reported diagnosis) and IC (presence of symptoms reported on the San Diego Claudication Questionnaire)
  • able to participate in MOSAIC
  • able and willing to provide informed consent

排除标准

  • Unstable IC (self-reported change in symptoms during previous 3 months)
  • walking >90 minutes/week (reported on Brief International Physical Activity Questionnaire
  • contraindications to walking exercise (e.g., unstable angina) confirmed by their vascular specialist
  • have completed any prescribed supervised exercise sessions in the previous 6 months or been offered prescribed exercise sessions in the next 6 months.

结局指标

主要结局

6 Minute Walk Distance

时间窗: 3 months

6 Minute Walking Distance (in metres) measured during a self-paced, standardised 6 Minute Walk Test conducted around a level, 100-foot circuit.

次要结局

  • 6 Minute Walk Distance (6MWD)(Baseline and 3 months)
  • Health-Related Quality of Life(Baseline, 3 and 6 months)
  • Self-reported Maximum Walking Distance(Baseline, 3 and 6 months)
  • Self-Reported Walking Ability(Baseline, 3 and 6 months)
  • Activities of Daily Living(Baseline, 3 and 6 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (9)

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