혈액투석 환자의 상지와 하지 체성분, 기능적 능력 및 근육 산소화에 대한 혼합형 투석 중 운동 훈련 프로그램의 효과
혈액투석 환자에서 혼합형 투석 중 운동 훈련 프로그램이 상·하지의 체성분, 기능적 능력 및 근육 산소화에 미치는 영향
Chronic kidney disease (CKD) is a progressive clinical condition that affects a growing number of people worldwide. While advances in haemodialysis techniques have led to notable improvements in survival rates and the quality of life (QoL) of patients with CKD (PwCKD), significant complications persist, primarily associated with chronic uremia. These include skeletal muscle atrophy, reduced muscular strength and diminished functional capacity.
Recent studies support the role of systematic exercise as a non-pharmacological strategy to reduce issues and improve musculoskeletal function among haemodialysis patients. Specifically, intradialytic exercise gained ground due to its efficiency in time utilization and elimination of transport burden. Nevertheless, most of the intradialytic exercise programs implement aerobic exercise and there is a lack of studies investigating combined strength and aerobic exercise modalities, which may offer more comprehensive physiological benefits.
The aim of the randomized controlled trial (RCT) is to examine whether a 6-month combined aerobic and resistance exercise program, implemented during haemodialysis sessions, could affect body composition, muscle oxygenation of the lower and upper extremities, and functional capacity of patients that underwent haemodialysis.
Forty patients will be randomly allocated into two groups: Group A (Exercise Group) will undergo 3 sessions per week of an intradialytic exercise program for 6 months and Group B (Control Group) will receive the usual care without participating in organized exercise programs.
Prior to the group random allocation, part of our assessments at baseline and after 6 (Evaluation A') will include demographics and clinical history, body composition analysis via bioelectrical impedance analysis, muscle oxygenation monitoring of the vastus lateralis and biceps brachii muscles at rest and during exercise using near-infrated spectroscopy (NIRS) technology. Functional capacity will be assessed through validated tests: Six-minute walk test (6MWT), 30-second sit-to-stand test, five-repetition sit-to-stand test (5STS), handgrip strength, 4-meter gait speed test. Additionally, we will use questionnaires assessing physical activity using International Physical Activity Questionnaire (IPAQ), depression using Beck Depression Inventory (BDI), stress using Generalized Anxiety Disorder 7-item scale(GAD-7) and the QoL using Kidney Disease Quality of Life Short Form(KDQOL-SF) of people that underwent dialysis.
연구 개요
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
-
-
-
Thessaloniki, 그리스, 57001
- Sports Medicine Laboratory, Aristotle University of Thessaloniki
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Age > 18 and <80 years, either gender
- Confirmed diagnosis
- Patients undergoing maintenance hemodialysis therapy for at least 6 months.
Exclusion Criteria:
- Acute myocardial infraction
- Severe valvular disease
- Potentially malignant arrhythmias
- Unstable angina
- Hospitalized patients
- Uncontrolled diabetes mellitus
- Uncontrolled hypertension
- Neurological, or orthopedic limitations/non-ambulant status
- Cognitive or psychiatric disorders
- Poor regulation of comorbidities
- Already participating in organized exercise programs
- Current pregnancy
- Inability/unwillingness to give informed consent
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: Exercise
Exercise Group, 6- month combined aerobic and strength exercise |
Patients randomly assigned to this group will be invited to attend a 6 month exercise program. The 6-month exercise intervention will be conducted three times per week during the first two hours of each hemodialysis session at the 2nd Nephrology Clinic at AHEPA University Hospital. Each session will begin with a warm-up phase, followed by aerobic exercise using bedside-adapted cycle ergometers. Exercise duration will initially be set at 30 minutes and progressively increased to 60 minutes, performed at moderate intensity (12-13 on the 6-20 Borg Rating of Perceived Exertion scale). After the first month, resistance training will be gradually introduced, initially using body weight and subsequently incorporating elastic resistance bands. Each session will conclude with a cool-down period. |
|
간섭 없음: Usual care
Control Group, 6- month without participating in organized exercise activities, no intervention |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
임상 및 인구통계학적 특성
기간: 기준선
|
기준선
|
|
|
임상 및 인구통계학적 특성
기간: 6개월
|
6개월
|
|
|
4미터 보행 속도 검사
기간: 기준선
|
기준선
|
|
|
4미터 보행 속도 테스트
기간: 6개월
|
6개월
|
|
|
기준 다이나모미터 측정
기간: 기준선
|
기준선
|
|
|
기준선 다이나모미터
기간: 6개월
|
6개월
|
|
|
Muscle oxygenation Assessment-MOXY
기간: Baseline
|
Measurement of vastus lateralis and biceps brachii muscle oxygenation at rest and during exercise using near-infrared spectroscopy (NIRS) devices (Moxy 1408, Fortiori Design LLC, Minnesota, USA; Moxy 2136, Idiag AG, Fehraltorf, Switzerland). |
Baseline
|
|
Muscle oxygenation Assessment-MOXY
기간: 6-month
|
Measurement of vastus lateralis and biceps brachii muscle oxygenation at rest and during exercise using near-infrared spectroscopy (NIRS) devices (Moxy 1408, Fortiori Design LLC, Minnesota, USA; Moxy 2136, Idiag AG, Fehraltorf, Switzerland). |
6-month
|
|
Body composition analysis
기간: Baseline
|
Bioelectrical impedance analysis (Bodystat QuadScan 4000). |
Baseline
|
|
Body composition analysis
기간: 6-month
|
Bioelectrical impedance analysis (Bodystat QuadScan 4000). |
6-month
|
|
Six minute walk test
기간: Baseline
|
Aerobic capacity |
Baseline
|
|
Six minute walk test
기간: 6-month
|
Aerobic capacity |
6-month
|
|
JAMAR SMART Hand Dynamometer
기간: Baseline
|
Handgrip Strength |
Baseline
|
|
JAMAR SMART Hand Dynamometer
기간: 6- month
|
Handgrip Strength |
6- month
|
|
30-second Sit-to-Stand Test
기간: Baseline
|
Lower limb functional capacity |
Baseline
|
|
30-second Sit-to-Stand Test
기간: 6- month
|
Lower limb functional capacity |
6- month
|
|
Five-Repetition Sit-to-Stand Test (5STS)
기간: Baseline
|
Lower limb functional capacity |
Baseline
|
|
Five-Repetition Sit-to-Stand Test (5STS)
기간: 6- month
|
Lower limb functional capacity |
6- month
|
|
International Physical Activity Questionnaire (IPAQ).
기간: Baseline
|
Assessment of Physical Activity (PA) Levels (MET-min/week). Using the IPAQ scoring protocol, participants classified into three PA categories: low (<600 MET-min/week), moderate, and high (active) (≥3000 MET-min/week or vigorous PA ≥1500 MET-min/week). Higher scores indicate more physically active patients. |
Baseline
|
|
International Physical Activity Questionnaire (IPAQ).
기간: 6- month
|
Assessment of Physical Activity (PA) Levels (MET-min/week). Using the IPAQ scoring protocol, participants classified into three PA categories: low (<600 MET-min/week), moderate, and high (active) (≥3000 MET-min/week or vigorous PA ≥1500 MET-min/week). Higher scores indicate more physically active patients. |
6- month
|
|
Beck Depression Inventory (BDI)
기간: Baseline
|
Assessment of depressive symptoms. Total score ranges from 0 to 63. Each item is scored 0-3, where higher scores indicate more severe symptoms. Typical interpretations are: 0-13 (minimal), 14-19 (mild), 20-28 (moderate), and 29-63 (severe). |
Baseline
|
|
Beck Depression Inventory (BDI)
기간: 6- month
|
Assessment of depressive symptoms. Total score ranges from 0 to 63. Each item is scored 0-3, where higher scores indicate more severe symptoms. Typical interpretations are: 0-13 (minimal), 14-19 (mild), 20-28 (moderate), and 29-63 (severe). |
6- month
|
|
Generalized Anxiety Disorder-7 scale (GAD-7).
기간: Baseline
|
Assessment of anxiety symptoms. The Generalized Anxiety Disorder-7 scale (GAD-7) is a 7-item self-report questionnaire assessing anxiety symptoms over the past 2 weeks, with a total score range of 0-21 (items scored 0-3). Severity categories are 0-4 minimal, 5-9 mild, 10-14 moderate, and 15-21 severe; Higher scores indicate more severe anxiety symptoms. |
Baseline
|
|
Generalized Anxiety Disorder-7 scale (GAD-7).
기간: 6- month
|
Assessment of anxiety symptoms. The Generalized Anxiety Disorder-7 scale (GAD-7) is a 7-item self-report questionnaire assessing anxiety symptoms over the past 2 weeks, with a total score range of 0-21 (items scored 0-3). Severity categories are 0-4 minimal, 5-9 mild, 10-14 moderate, and 15-21 severe; Higher scores indicate more severe anxiety symptoms. |
6- month
|
|
Kidney Disease Quality of Life Short Form (KDQOL-SF™)
기간: Baseline
|
Assessment of health-related quality of life. The Kidney Disease Quality of Life Short Form (KDQOL-SF™) assesses kidney disease-specific and general health. Domain scores range from 0-100 scale (minimum 0; maximum 100). Higher scores indicate better quality of life. |
Baseline
|
|
Kidney Disease Quality of Life Short Form (KDQOL-SF™)
기간: 6- month
|
Assessment of health-related quality of life. The Kidney Disease Quality of Life Short Form (KDQOL-SF™) assesses kidney disease-specific and general health. Domain scores range from 0-100 scale (minimum 0; maximum 100). Higher scores indicate better quality of life. |
6- month
|
공동 작업자 및 조사자
수사관
- 연구 의자: Evangelia Kouidi, Professor, Sports Medicine Laboratory, School of Physical Education and Sports Science, Aristotle University of Thessaloniki, Greece
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 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 121/2022
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. .