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临床试验/NCT03941145
NCT03941145已完成不适用

Effectiveness of a Novel Workplace-based Exercise Intervention: a Pilot Study

University of Stirling1 个研究点 分布在 1 个国家目标入组 23 人开始时间: 2019年5月1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
23
试验地点
1
主要终点
Change in maximal aerobic capacity

研究概览

简要总结

Sufficient physical activity and a good cardiorespiratory fitness level (CRF) are central in cardiovascular disease (CVD) risk reduction. However, many people remain inactive, partly because current exercise recommendations fail to address important barriers to exercise. A novel exercise protocol has previously been developed called 'reduced-exertion high-intensity interval training' (REHIT), which can remove several common perceived barriers to exercise. REHIT 1) improves CRF and other key CVD risk factors, 2) is genuinely time-efficient (total time-commitment of just 2x10 min per week), 3) is well-tolerated, manageable, and not associated with negative affective responses, and 4) can be done in the workplace, in work-clothes and without a need to shower afterwards. To date, this intervention has only been investigated in a lab-setting. Therefore, in the present randomised controlled trial, the 'real-world' effectiveness of REHIT in improving maximal aerobic capacity (V̇O2max; a key risk factors of CVD) will be investigated in a workplace setting. Participants' attitudes and psychological responses to REHIT will be assessed to evaluate the likelihood of successful implementation. In 2 study centres, a total of up to n=50 physically inactive male and female office workers will be recruited to perform 6 weeks of unsupervised, computer-guided, office-based REHIT (n=25) or act as a control (n=25).

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 60 Years(Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Employee at participating workplace

排除标准

  • •Aged < 18 years or > 60 years
  • •History of type 2 diabetes
  • •Insulin therapy
  • •Use of β-blockers
  • •Use of inhaled steroids (e.g. for asthma)
  • •Any cardiovascular condition with the exception of well-controlled uncomplicated hypertension (systolic >140 mm Hg and/or >90 mm Hg after at least 5 minutes of seated rest), which is treated with no more than two drugs (either an ACE, ARB, calcium channel blocker, or diuretic)
  • •Cerebrovascular disease including previous stroke or aneurysm
  • •History of exercise-induced asthma
  • •History of type 1 diabetes mellitus or a history of ketoacidosis
  • •History of other specific types of diabetes (e.g., genetic syndromes, secondary pancreatic diabetes, diabetes due to endocrinopathies, drug or chemical-induced, and post organ transplant)
  • •History of respiratory disease including pulmonary hypertension or chronic obstructive pulmonary disease
  • •History of musculoskeletal or neurological disorders
  • •Active inflammatory bowel disease
  • •History of renal disease
  • •Other metabolic diseases, including hyper/ hypo-parathyroidism, hyper/hypo-thyroidism, and Cushing's disease.
  • •BMI>35 kg/m2
  • •A clinically significant resting ECG abnormality at the pre-screening visit which in the opinion of the cardiologist exposes the participant to risk by take part in the main trial.
  • •'Yes' to any questions on a standard physical activity readiness questionnaire (PARQ)
  • •Classification as moderately or highly physically active on the International Physical Activity Questionnaire (IPAQ)
  • •Current participation in another research study
  • •Inability to fully understand the verbal and written descriptions of the study in English, and the instructions provided during the study

研究组 & 干预措施

Exercise

Experimental

Participants allocated to the intervention group will be asked to perform 2 exercise sessions per week for 6 weeks. Each session will involve 10 min of low-intensity cycling (25 W) interspersed with two 20-s 'all-out' cycle sprints against a resistance equivalent to 5% of body mass. The exercise intervention will be delivered on a commercially available cycle ergometer with software developed by CAR.O.L.

干预措施: Reduced-Exertion High-Intensity Interval Training (REHIT) (Behavioral)

Control

No Intervention

The effects of the intervention will be compared to a no-intervention control group recruited from the same workplace settings.

结局指标

主要结局

Change in maximal aerobic capacity

时间窗: Change from baseline to 3 days after the 6-week intervention

Aerobic capacity: a key risk factor of noncommunicable disease

次要结局

  • Change in motivation for exercise(Change from baseline to 3 days after the 6-week intervention)
  • Change in perceived stress(Change from baseline to 3 days after the 6-week intervention)
  • Intervention acceptability(3 days after the 6-week intervention)
  • Change in health status(Change from baseline to 3 days after the 6-week intervention)

研究者

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

Niels Vollaard

Principal Investigator

University of Stirling

研究点 (1)

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