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临床试验/NCT04649528
NCT04649528已完成不适用

Digitally Assisted High-intensity Interval Training in Inflammatory Rheumatic Disease Patients: Treatment by Man or Machine?

Molde University College1 个研究点 分布在 1 个国家目标入组 49 人开始时间: 2018年1月3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
发起方
入组人数
49
试验地点
1
主要终点
Change in physiological measures

研究概览

简要总结

The purpose of this study is to compare two modes of delivering high-intensity interval training (HIIT) in a population with inflammatory rheumatic disease over 10 weeks. One group will recieved HIIT supervised by a healthcare professional, the other group will perform self-monitored HITT with guidance by a smarthpone application.

详细描述

People with inflammatory rheumatic diseases (IRS) such as rheumatoid arthritis (RA), spondyloarthritis (SpA) and systemic lupus erythematosus (SLE) have been shown to have reduced cardiovascular fitness and quality of life than the general population. Cardiovascular health is the single most important factor of total mortality. It has been shown previously that individuals with IRS tolerate both endurance training, resulting in improvement in function and cardiovascular health while also having a positive effect on disease activity measured through inflammation, pain, joint health and fatigue. In recent years, studies have also been conducted that demonstrate both the safety and effect of aerobic 4x4min high-intensity interval training (HIIT) for patients with IRS.

This study will involve an intervention period consisting of 20 HIIT sessions. Participants are randomized into one of two training groups. One group will perform HIIT under the supervision of a healthcare professional. The other group will perform the same HIIT training with identical instructions, however they will be self-monitored with the aid and guidance of a mobilephone application.

The purpose of the intervention is to increase maximum oxygen uptake and improve quality of life. The intervention period will consist of 2 weekly sessions lasting approximately 35 minutes performed on non-consecutive days. The endurance training will consist of 4 intervals of 4 minutes duration, separated by a 3-4 minute active break and follows the principle of intensive aerobic interval training. Before and after the training period, identical testing (approximately 30-40 min) will be performed by both intervention groups. The testing will include measurements of work economy and maximal oxygen uptake in an endurance test. Additionally, quality of life questionnaires will be obtained.

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
Single (Investigator)

盲法说明

The exercise physiologist performing the maximal oxygen uptake pre and posttests was blinded with reguards to which intervention group the participants had been assigned.

入排标准

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

入选标准

  • •- Inflammatory rheumatic disease

排除标准

  • •Inability to complete the testing procedures
  • •Not able to perform exercise intervention
  • •Planed surgeries or other plans during initial exercise intervention period than directly will effect the testing or training.
  • •Access to a smartphone
  • •Less than 80% compliance of planned training sessions

研究组 & 干预措施

Supervised HIIT

Experimental

Exercise intervention, 20 supervised by healthcare professional

干预措施: Effective endurance 4x4 training - Supervised (Behavioral)

APP HIIT

Experimental

Exercise intervention, 20 self-monitored assisted by a mobilephone application

干预措施: Effective endurance 4x4 training - APP (Device)

结局指标

主要结局

Change in physiological measures

时间窗: At baseline and after 10 weeks of HIIT

Maximal oxygen uptake

次要结局

  • Change in health-related quality of life(At baseline and after 10 weeks of HIIT)

研究者

发起方
Molde University College
申办方类型
Other
责任方
Sponsor

研究点 (1)

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