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临床试验/NCT07363447
NCT07363447已完成不适用

The Role of Supervision: Effects of Different Telerehabilitation Methods In Patients With Hypertension

Hacettepe University1 个研究点 分布在 1 个国家目标入组 31 人开始时间: 2024年2月28日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
31
试验地点
1
主要终点
Exercise Capacity

研究概览

简要总结

This study aims to compare two different ways of providing exercise therapy to people with high blood pressure (hypertension) through digital technology. Participants are divided into two groups: one group performs exercises at home while being watched and guided by a physiotherapist in real-time through video calls (synchronous). The other group performs the same exercises by watching pre-recorded videos on their own (asynchronous). The study measures how these two methods affect the patients' exercise capacity, daily blood pressure levels, heart functions, and their ability to manage their own health over an 8-week period.

详细描述

In this randomized, controlled, single-blinded study, 35 hypertensive individuals are assigned to either a synchronous telerehabilitation (STR) or an asynchronous telerehabilitation (ATR) group. Both groups perform an 8-week aerobic-based calisthenics program consisting of 24 sessions (3 sessions per week, 45 minutes each). The STR group exercises under the live supervision of a physiotherapist via videoconferencing. The ATR group uses pre-recorded video content and maintains an exercise diary. During all sessions, heart rate is monitored in real-time using wearable smartbands to maintain a submaximal intensity (70-85% of age-predicted maximum heart rate). Assessments performed at baseline and at the 8th week include ambulatory blood pressure monitoring (ABPM), transthoracic echocardiography (TTE), maximal stress tests, self-care inventories, physical activity and body composition.

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
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Diagnosis of systemic hypertension.
  • Age between 18 and 65 years.
  • Access to the internet.
  • Ownership of a mobile device suitable for telerehabilitation participation.

排除标准

  • Presence of comorbid cardiovascular and/or pulmonary diseases.
  • Unstable metabolic conditions.
  • History of cerebrovascular and/or cardiovascular disease events within the past three months.
  • Mental disorders that interfere with exercise cooperation.
  • Balance or fall-related problems.
  • Orthopedic or neurological conditions that compromise the safety of exercise.

研究组 & 干预措施

Synchronous Telerehabilitation (STR)

Active Comparator

8-week aerobic-based calisthenics (3 sessions/week, 45 min/session) under real-time physiotherapist supervision via videoconferencing.

干预措施: Synchronous Cardiac Telerehabilitation (Behavioral)

Asynchronous Telerehabilitation (ATR)

Active Comparator

8-week aerobic-based calisthenics (3 sessions/week, 45 min/session) delivered via pre-recorded videos and exercise diaries.

干预措施: Asynchronous Cardiac Telerehabilitation (Behavioral)

结局指标

主要结局

Exercise Capacity

时间窗: Before and after the training (0 and 8th Week)

Change in Functional Exercise Capacity (6-Minute Stepper Test); The number of steps completed within six minutes using a stepper device. Higher step counts indicate better functional capacity.

Exercise Capacity

时间窗: Before and after the training (0 and 8th weeks)

Predicted maximal oxygen uptake; Calculated from the duration of the maximal stress test (Bruce protocol) using validated formulas for men and women. It represents maximal aerobic capacity in mL/kg/min.

次要结局

  • Blood Pressure Levels(Before and after the training (0 and 8th weeks))
  • Cardiac Functions(Before and after the training (0 and 8th weeks))
  • Self-Care Levels(Before and after the training (0 and 8th weeks))
  • Postural Stability and Upper Extremity Function(Before and after the training (0 and 8th weeks))
  • Lower Extremity Muscle Function(Before and after the trainining (0 and 8th weeks))
  • Objective Physical Activity Level(Before and after the training (0 and 8th weeks))
  • Subjective Physical Activity Levels(Before and after the training (0 and 8th weeks))
  • Body Mass Index(Before and after the training (0 and 8th weeks))
  • Body Composition-Anthropometric Measure(Before and after the training (0 and 8th weeks))
  • Body Fat Percantage(Before and after the training (0 and 8th weeks))
  • Fat Free Mass(Before and after the training (0 and 8th weeks))
  • Lipid Profile(Before and after the training (0 and 8th weeks))
  • Cardiovascular Disease (CVD) Risk Profile(Before and after the training (0 and 8the weeks))
  • Waist Circumference(Before and after the training (0 and 8th weeks))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Beyza Karadüz

PhD Student

Hacettepe University

研究点 (1)

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