- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03331679
Can 2 Weeks of High Intensity Interval Training in Healthy 65-85 Year-olds Improve Cardiorespiratory Fitness? (2WkHIT)
Exploring Time Efficient Strategies to Improve Fitness for Surgery in Older Adults- Two Weeks HIIT
Study Overview
Detailed Description
The percentage of people aged >65 y in the United Kingdom increased from 15% in 1985 to 17% in 2010, an increase of 1.7 million people. One age-associated physiological change is the reduction in vascular function that is observed, both at the levels of the large arteries and the muscle microvasculature. In itself this vascular dysfunction is associated with reduced aerobic performance. Cardiorespiratory fitness (marked by aerobic performance) has been shown to be an independent predictor of postoperative mortality, which provides more accurate prognostic information than age alone. In contrast, physical activity can reverse elements of pathophysiology associated with these conditions, including vascular dysfunction. Nonetheless, major roadblocks to exercise as a strategy to combat age-associated vascular dysfunction and associated conditions exist, such as poor exercise tolerance and "lack of time".
The aim of this study is to investigate whether if novel low-volume, time-efficient training strategies can improve indices of vascular health and cardiorespiratory performance in older individuals with a view towards improving their fitness for surgery. Numerous studies have demonstrated that periods of supervised exercise training effectively improve indices of cardiorespiratory (blood pressure, aerobic capacity and blood lipids and vascular function. However, the majority of these studies were conducted using high-volume continuous submaximal aerobic training (e.g. 50-65% VO2max for 30-60 min) or moderate to high volume progressive weight training. This research group have recently shown the efficacy of a time-efficient exercise strategy known as HIIT - High Intensity Interval Training, for improving VO2 max and muscle mass in young individuals with heightened metabolic disease risk and also demonstrated significant improvements in VO2 max comparable to classic aerobic exercise training using several different time-efficient HIIT protocols in as little as 4 weeks. This study aims to quantify the benefits of 2 weeks of HIIT.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Derby, United Kingdom, DE22 3DT
- medical school
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Healthy Volunteer aged 65-85
Exclusion Criteria:
- Current participation in a formal exercise regime
- BMI < 18 or > 32 kg·m2
- Active cardiovascular disease:
- uncontrolled hypertension (BP > 160/100),
- angina,
- heart failure (class III/IV),
- Significant arrhythmia,
- right to left cardiac shunt,
- recent cardiac event
- Taking beta-adrenergic blocking agents,
- Cerebrovascular disease: previous stroke, aneurysm (large vessel or intracranial)
- epilepsy
- Respiratory disease including: pulmonary hypertension, Significant COPD, Uncontrolled asthma, Metabolic disease: -hyper and hypo parathyroidism, -untreated hyper and hypothyroidism, Cushing's disease, type 1 or 2 diabetes
- Active inflammatory bowel or renal disease
- Malignancy
- Clotting dysfunction
- Significant Musculoskeletal or neurological disorders
- Family history of early (<55y) death from cardiovascular disease
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 2 Wk HIIT
2 weeks of High Intensity Interval Training
|
2 Weeks of High Intensity Interval Training on a Cycle ergometer
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Anaerobic Threshold
Time Frame: 2 weeks
|
Anaerobic Threshold as measured at standard CPET conducted according to ATS/ACCP statement (measured in ml/Kg/min)
|
2 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
VO2 Peak
Time Frame: 2 Weeks
|
Maximum volume of oxygen consumed at CPET conducted according to ATS/ACCP statement (measured in ml/Kg/min)
|
2 Weeks
|
Whole-Body Lean Mass
Time Frame: 2 Weeks
|
Measured by DEXA (Kg)
|
2 Weeks
|
Body Fat percentage
Time Frame: 2 Weeks
|
Measured by DEXA
|
2 Weeks
|
Leg Lean Mass
Time Frame: 2 Weeks
|
Measured by DEXA (Kg)
|
2 Weeks
|
Handgrip Strength
Time Frame: 2 Weeks
|
Maximum voluntary contraction
|
2 Weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- A12092016 amendment 4
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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