Clinical Efficacy of IoMT-based Exercise Program for the Elderly
Clinical Efficacy of IoMT-based Exercise Program for the Elderly With Chronic Musculoskeletal Disorders
연구 개요
상세 설명
This study presents the protocol of a prospective, single-center, single-blinded, two-armed randomized controlled trial.
The investigators plan to recruit patients over 65 years of age with degenerative knee arthritis or chronic low back pain. Patients will be randomly divided into two groups with 1:1 allocation.
The intervention group will receive 6 weeks of the IoT-based home exercise program. The IoMT-based home exercise program is implemented to the patients via a smartphone application. The home exercise program sets the exercise intensity to 3 levels (low, medium, and high) according to the disease and consists of 2 stretches, 3 strengthening and/or functional exercises, and a cool-down exercise (Figure 1). The exercise group applies a daily home exercise program (30min/day, 7days/week for 6 weeks).
The activity detector records the amount of activity and the speed of movement within the home. The door sensor detects the enter and exit and records the number of outings. The pillbox notifies subjects to take the medication time. The smart-care phone provides emergency call and guardian connection services. The body composition analyzer measures body mass index, fat, and muscle mass.
The primary outcome in patients with degenerative knee arthritis is Western Ontario and McMaster Universities Osteoarthritis. And the primary outcome in patients with chronic low back pain is Oswestry Disability Index. The secondary outcomes are numeric rating scale for pain, 36-Item Short-Form Health Survey, Geriatric Depression Scale, Timed-Up and Go test, and 30s chair sit and stand.
The investigators evaluate primary and secondary outcomes before and after the home exercise programs.
연구 유형
등록 (예상)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Jeongyi Kwon, M.D,PhD
- 전화번호: +82-2-3410-2818
- 이메일: jeongyi.kwon@samsung.com
연구 장소
-
-
-
Seoul, 대한민국, 06351
- 모병
- Samsung Medical Center
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Knee pain for more than 3months, Kellgren-Lawrence grade 2 or higher
- Low back pain for more than 3months
- A person who underdtands the exercise program
- Numeric rating scale of 4 or higher
Exclusion Criteria:
- History of knee surgery
- Systemic inflammatary disease
- History of polyneuropathy
- History of stroke
- Severe heart failure
- Chronic obstructive pulmonary disease
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: Home-based exercise program
The subjects will receive 6 weeks of the home exercise program via a smartphone application.
The home exercise program sets the exercise intensity to 3 levels (low, medium, and high) according to the disease and consists of 2 stretches, 3 strengthening and/or functional exercises, and a cool-down exercise.
The exercise group applies a daily home exercise program (30min/day, 7days/week for 6 weeks).
|
Daily home based exercise program (30min/day, 7days/week for 6 weeks).
|
|
간섭 없음: Exercise brochure
This group will be offered a brochure including number of exercises for back or knee.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Western Ontario and McMaster Universities Osteoarthritis
기간: baseline
|
Knee osteoarthritis functional index (Range: 0-96)
|
baseline
|
|
Western Ontario and McMaster Universities Osteoarthritis
기간: after 6weeks
|
Knee osteoarthritis functional index (Range: 0-96)
|
after 6weeks
|
|
Oswestry Disability Index
기간: baseline
|
Low back pain functional index (Range: 0-100)
|
baseline
|
|
Oswestry Disability Index
기간: after 6weeks
|
Low back pain functional index (Range: 0-100)
|
after 6weeks
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Numeric rating scale
기간: baseline
|
Pain score, The higher score means the worse pain (Range: 0-10)
|
baseline
|
|
Numeric rating scale
기간: after 6weeks
|
Pain score, The higher score means the worse pain (Range: 0-10)
|
after 6weeks
|
|
36-Item Short-Form Health Survey
기간: baseline
|
Qualify of life, The higher score means the better condition (Range: 0-100)
|
baseline
|
|
36-Item Short-Form Health Survey
기간: after 6weeks
|
Qualify of life, The higher score means the better condition (Range: 0-100)
|
after 6weeks
|
|
Geriatric Depression Scale
기간: baseline
|
Depression score, The higher score means the worse condition (Range: 0-15)
|
baseline
|
|
Geriatric Depression Scale
기간: after 6weeks
|
Depression score, The higher score means the worse condition (Range: 0-10)
|
after 6weeks
|
|
Timed-Up and Go test
기간: baseline
|
Dynamic balance, The higher score means the worse balance.
|
baseline
|
|
Timed-Up and Go test
기간: after 6weeks
|
Dynamic balance, The higher score means the worse balance.
|
after 6weeks
|
|
30s chair sit and stand
기간: baseline
|
Balance, The higher score means the better condition.
|
baseline
|
|
30s chair sit and stand
기간: after 6weeks
|
Balance, The higher score means the better condition.
|
after 6weeks
|
공동 작업자 및 조사자
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 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. .