- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT04031092
Use of Wearable Tech to Increase Physical Activity in Inpatient Rehabilitation for Patients With Chronic Pain
연구 개요
상태
상세 설명
Chronic pain is a vast problem with profound consequences for individuals and societies. Exercise and physical activity is an important part of the treatment for chronic pain. Use of wearable tech might be a way to help facilitate physical activity in patients with chronic pain. Here it will be evaluated whether use of wearable tech giving feedback about the user's activity level increases physical activity in patients participating in inpatient rehabilitation for chronic pain. The control group will be wearing the same wearable tech as the intervention group, but they will not receive any feedback about their activity level.
The feedback application will give participants in the intervention group information about the number of PAI they earn each week. PAI is short for personal activity Intelligence. You earn PAI points every time your heart rate increases: The higher heart rate, the faster you earn PAI. Previous research have shown that those who achieve 100 PAI or more every week over time live for an average of more than eight years longer than others.
During the study all participants will take part in a traditional inpatient rehabilitation program. The program consist of two periods at the rehabilitation center with two weeks at home in-between. The study will take place during the two periods at the senter and the period at home. Time spent on physical activity and number of earned PAI's will be counted during the period at home.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Rissa, 노르웨이
- Unicare Helsefort
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- taking part in inpatient rehabilitation at Unicare Helefort Rehabilitation center for chronic pain.
Exclusion Criteria:
- not having a smartphone (will not be able to access the mobile application).
- using a wheelchair (the technology will be not able to measure activity correctly)
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 |
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활성 비교기: 피드백 없는 웨어러블 기술
이 그룹은 개입 그룹과 동일한 활동 측정 장치를 착용하지만 활동 수준에 대한 피드백은 받지 않습니다.
모바일 애플리케이션에 액세스할 수 없습니다.
그들은 개입 그룹과 동일한 재활 프로그램에 참여하게 됩니다.
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traditional inpatient rehabilitation program.
An armwrist device measuring physical activity level, no reporting back to the user.
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실험적: Wearable tech with feedback
This group will be wearing an activity measurement device (wristband) and receive feedback about their activity level through a mobile application while taking part in a traditional inpatient rehabilitation program for patients with chronic pain.
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An armwrist device measuring physical activity level.
The user will receive information about their physical activity level through their smartphone.
traditional inpatient rehabilitation program.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Activity level
기간: 2 weeks (time period at home between two stays at the rehabilitation center)
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Time spent in moderate to vigorous physical activity (minutes per day)
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2 weeks (time period at home between two stays at the rehabilitation center)
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Number of PAIs
기간: 2 weeks (time period at home between two stays at the rehabilitation center)
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mean number of Personal Activity Intelligence (PAI) points achieved per week
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2 weeks (time period at home between two stays at the rehabilitation center)
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Percentage achieving 100 PAIs per week
기간: 2 weeks (time period at home between two stays at the rehabilitation center)
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Personal Activity Intelligence (PAI)
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2 weeks (time period at home between two stays at the rehabilitation center)
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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oxygen uptake
기간: 6 weeks (from inclusion to end of rehabilitation program)
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submaximal oxygen uptake measured by the Åstrand bicycle test (described in Textbook of work physiology by Astrand from 1986)
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6 weeks (from inclusion to end of rehabilitation program)
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Anxiety and depression symptoms
기간: 6 weeks (from inclusion to end of rehabilitation program)
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HSCL-25 questionnaire
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6 weeks (from inclusion to end of rehabilitation program)
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Average pain
기간: 6 weeks (from inclusion to end of rehabilitation program)
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Visual Analogue Scale (VAS).
VAS is a straight horizontal line where the ends are defined as the extreme limits from the left (0-no pain) to the right (100-worst imaginable pain).
The patient is asked to mark his pain level on the line between the two endpoints.
The distance between 'no pain at all' and the mark then defines the subject's pain.
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6 weeks (from inclusion to end of rehabilitation program)
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Health related quality of life
기간: 6 weeks (from inclusion to end of rehabilitation program)
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EQ5D questionnaire
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6 weeks (from inclusion to end of rehabilitation program)
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Body weight
기간: 6 weeks (from inclusion to end of rehabilitation program)
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body weight in kilograms
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6 weeks (from inclusion to end of rehabilitation program)
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Body Mass Index score
기간: 6 weeks (from inclusion to end of rehabilitation program)
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weight in kilograms divided by height in metres squared
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6 weeks (from inclusion to end of rehabilitation program)
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공동 작업자 및 조사자
수사관
- 수석 연구원: Lene Aasdahl, PhD MD, National Taiwan Normal University
- 연구 책임자: Jorunn Helbostad, Dr Philos, Norwegian University of Science and Technology
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
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 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. .
근골격계 통증에 대한 임상 시험
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Bingol UniversityAtaturk University아직 모집하지 않음수술 전 불안 | 두려움 | PAIN
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Weill Medical College of Cornell UniversityNew York University; National Center for Complementary and Integrative Health (NCCIH)모병
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Istanbul University모병Masticatory Muscle Pain | 근시 통증 증후군 (MP)칠면조
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Istanbul University모병이갈이 | 근막 통증 증후군 | Masticatory Muscle Pain | 현지 근육통터키 (Türkiye)