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Can 2 Weeks of High Intensity Interval Training in Healthy 65-85 Year-olds Improve Cardiorespiratory Fitness? (2WkHIT)

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ClinicalTrials.gov Identifier: NCT03331679
Recruitment Status : Completed
First Posted : November 6, 2017
Last Update Posted : March 12, 2019
Sponsor:
Information provided by (Responsible Party):
University of Nottingham

Tracking Information
First Submitted Date  ICMJE October 27, 2017
First Posted Date  ICMJE November 6, 2017
Last Update Posted Date March 12, 2019
Actual Study Start Date  ICMJE January 23, 2018
Actual Primary Completion Date August 1, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 31, 2017)
Anaerobic Threshold [ Time Frame: 2 weeks ]
Anaerobic Threshold as measured at standard CPET conducted according to ATS/ACCP statement (measured in ml/Kg/min)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 8, 2019)
  • VO2 Peak [ Time Frame: 2 Weeks ]
    Maximum volume of oxygen consumed at CPET conducted according to ATS/ACCP statement (measured in ml/Kg/min)
  • Whole-Body Lean Mass [ Time Frame: 2 Weeks ]
    Measured by DEXA (Kg)
  • Body Fat percentage [ Time Frame: 2 Weeks ]
    Measured by DEXA
  • Leg Lean Mass [ Time Frame: 2 Weeks ]
    Measured by DEXA (Kg)
  • Handgrip Strength [ Time Frame: 2 Weeks ]
    Maximum voluntary contraction
Original Secondary Outcome Measures  ICMJE
 (submitted: October 31, 2017)
  • VO2 Peak [ Time Frame: 2 Weeks ]
    Maximum volume of oxygen consumed at CPET conducted according to ATS/ACCP statement (measured in ml/Kg/min)
  • Lean Body Mass [ Time Frame: 2 Weeks ]
    Measured by DEXA (Kg)
  • Body Fat percentage [ Time Frame: 2 Weeks ]
    Measured by DEXA
  • Handgrip Strength [ Time Frame: 2 Weeks ]
    Maximum voluntary contraction
  • Vastus Lateralis Pennation Angle [ Time Frame: 2 Weeks ]
    Measured by Ultrasound
  • Vastus Lateralis muscle thickness [ Time Frame: 2 Weeks ]
    Measured by Ultrasound
  • Vastus Lateralis muscle fascicle length [ Time Frame: 2 Weeks ]
    Measured by Ultrasound
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Can 2 Weeks of High Intensity Interval Training in Healthy 65-85 Year-olds Improve Cardiorespiratory Fitness?
Official Title  ICMJE Exploring Time Efficient Strategies to Improve Fitness for Surgery in Older Adults- Two Weeks HIIT
Brief Summary The incidence of conditions requiring surgical intervention increases with age, however there is a reported decline in the rates of elective surgical procedures in those over 65. This is associated with older patients being described as "less fit" and more at risk of postoperative complications, leading to decreased provision of surgical care to those at need. Exercise interventions have the potential to reverse some of the decline in cardiovascular fitness associated with aging and improve the elderly's' "fitness for surgery" and potentially allow increased access to surgical care for those most in need of it.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Cardiorespiratory Fitness
Intervention  ICMJE Behavioral: HIIT
2 Weeks of High Intensity Interval Training on a Cycle ergometer
Study Arms  ICMJE Experimental: 2 Wk HIIT
2 weeks of High Intensity Interval Training
Intervention: Behavioral: HIIT
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 8, 2019)
10
Original Estimated Enrollment  ICMJE
 (submitted: October 31, 2017)
12
Actual Study Completion Date  ICMJE December 1, 2018
Actual Primary Completion Date August 1, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 65 Years to 85 Years   (Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03331679
Other Study ID Numbers  ICMJE A12092016 amendment 4
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party University of Nottingham
Study Sponsor  ICMJE University of Nottingham
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University of Nottingham
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP