Motivating Structured Walking Activity in Intermittent Claudication (MOSAIC)
A Brief Physiotherapist-led Behaviour Change Intervention to Facilitate Walking in Older People With Peripheral Arterial Disease: a Randomised Controlled Trial
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.
연구 개요
연구 유형
등록 (예상)
단계
- 해당 없음
연락처 및 위치
연구 장소
-
-
-
London, 영국
- 모병
- King's College Hospital NHS Foundation Trust
-
London, 영국
- 모병
- Royal Free London NHS Foundation Trust
-
London, 영국
- 모병
- Guy's & St Thomas NHS Foundation Trust
-
London, 영국
- 모병
- Lewisham and Greenwich NHS Trust (GSTT PIC site)
-
London, 영국
- 모병
- St George's University Hospital NHS Foundation Trust
-
London, 영국
- 모병
- The Royal London Hospital, Barts Heatth NHS Trust
-
-
Kent
-
Dartford, Kent, 영국
- 모병
- Dartford and Gravesham NHS Trust (GSTT PIC site)
-
Maidstone, Kent, 영국
- 모병
- Maidstone and Tunbridge Wells NHS Trust (GSTT PIC site)
-
-
Surrey
-
Ashford, Surrey, 영국
- 모병
- Ashford & St Peter's NHS Foundation Trust
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- ≥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
Exclusion Criteria:
- 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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: MOSAIC Treatment
MOSAIC treatment plus Usual NHS Care.
MOSAIC treatment comprises 2 x 60-minute individual face-to-face consultations (weeks 1 & 2) and 2 x 20-minute follow-up telephone calls (weeks 6 & 12) with a trained physiotherapist.
|
MOSAIC comprises 2 x 60-minute individual face-to-face consultations (weeks 1 & 2) and 2 x 20-minute follow-up telephone calls (weeks 6 & 12) delivered at a convenient time and location of participant's choice (local NHS Trust or participant's home).
All sessions are delivered by a trained Band 6/7 physiotherapist.
All participants randomized to receive MOSAIC will be provided with a pedometer and a patient manual which will include information on intermittent claudication, risk factors, walking guidelines, goal setting, problem solving and action planning worksheets and a walking diary.
다른 이름들:
|
|
간섭 없음: Usual Care Comparison
Usual NHS care for people with intermittent claudication typically consists of an initial assessment, drug therapy and simple advice to walk provided by a vascular specialist and delivered in the vascular outpatient clinic.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
6 Minute Walk Distance
기간: 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.
|
3 months
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
6 Minute Walk Distance (6MWD)
기간: Baseline and 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.
|
Baseline and 3 months
|
|
Self-reported Maximum Walking Distance
기간: Baseline, 3 and 6 months
|
Single global item
|
Baseline, 3 and 6 months
|
|
Self-Reported Walking Ability
기간: Baseline, 3 and 6 months
|
Walking Estimated-Limitation Calculated by History (WELCH)
|
Baseline, 3 and 6 months
|
|
Activities of Daily Living
기간: Baseline, 3 and 6 months
|
Nottingham Extended Activities of Daily Living (NEADL)
|
Baseline, 3 and 6 months
|
|
Health-Related Quality of Life
기간: Baseline, 3 and 6 months
|
Vascular Quality of Life Questionnaire-6 (VascuQol-6)
|
Baseline, 3 and 6 months
|
기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Treatment Cognitions
기간: Baseline, 3 and 6 months
|
Theory of Planned Behaviour Questionnaire
|
Baseline, 3 and 6 months
|
|
Illness Cognitions
기간: Baseline, 3 and 6 months
|
Brief Illness Perceptions Questionnaire (BIPQ)
|
Baseline, 3 and 6 months
|
|
Walking Adherence
기간: Baseline, 3 and 6 months
|
Exercise Adherence Rating Scale
|
Baseline, 3 and 6 months
|
|
Resource Use
기간: Baseline, 3 and 6 months
|
Client Service Receipt Inventory
|
Baseline, 3 and 6 months
|
|
Health Related Quality of Life
기간: Baseline, 3 and 6 months
|
Euroqol- 5D-5L
|
Baseline, 3 and 6 months
|
|
Pain Free Walking Ability
기간: Baseline and 3 months
|
Patient-reported pain free walking time (seconds) and distance (metres) during the 6 Minute Walk Test
|
Baseline and 3 months
|
|
Maximal Walking Ability
기간: Baseline and 3 months
|
The maximum time (seconds) and distance (metres) walked before stopping during a 6 Minute Walk Test
|
Baseline and 3 months
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Sanjay Patel, Guy's and St Thomas' NHS Foundation Trust
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (예상)
연구 완료 (예상)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- 17/LO/0568
- R477/0516 (기타 보조금/기금 번호: Dunhill Medical Trust)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
말초 동맥 질환에 대한 임상 시험
-
C. R. Bard완전한
-
Mayo Clinic초대로 등록
-
University Hospital, Strasbourg, France완전한
-
University Hospital, Strasbourg, France아직 모집하지 않음에크모 | Venoven VV 또는 Veno-Arterial VA의 mplementation | 집중 치료프랑스
-
L2 Bio, LLCFDAMap; Akan Biosciences, Inc.아직 모집하지 않음Crohn & amp;#39; s | Crohn & amp;#39; s Disease (CD)
-
UNC Lineberger Comprehensive Cancer CenterFogarty International Center of the National Institute of Health모집하지 않고 적극적으로
-
Vanderbilt University Medical CenterTakeda Pharmaceuticals U.S.A., Inc.모집하지 않고 적극적으로염증성 장질환(IBD) | 궤양성 대장염(UC) | Crohn & amp;#39; s Disease (CD)미국
-
Kaohsiung Medical University아직 모집하지 않음폐 선암종 | 폐암(진단) | Condition/Disease
MOSAIC에 대한 임상 시험
-
Medtronic Bakken Research Center완전한
-
University Hospital Plymouth NHS Trust완전한
-
Janssen Vaccines & Prevention B.V.완전한건강한미국, 멕시코, 스페인, 푸에르토 리코, 이탈리아, 폴란드, 아르헨티나, 브라질, 페루
-
National Institute of Allergy and Infectious Diseases...HIV Vaccine Trials Network; IPPOX Foundation; CHAVI; MHRP완전한