Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

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.

Condition or disease Intervention/treatment Phase
Cardiorespiratory Fitness Behavioral: HIIT Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Exploring Time Efficient Strategies to Improve Fitness for Surgery in Older Adults- Two Weeks HIIT
Actual Study Start Date : January 23, 2018
Actual Primary Completion Date : August 1, 2018
Actual Study Completion Date : December 1, 2018

Arm Intervention/treatment
Experimental: 2 Wk HIIT
2 weeks of High Intensity Interval Training
Behavioral: HIIT
2 Weeks of High Intensity Interval Training on a Cycle ergometer




Primary Outcome Measures :
  1. Anaerobic Threshold [ Time Frame: 2 weeks ]
    Anaerobic Threshold as measured at standard CPET conducted according to ATS/ACCP statement (measured in ml/Kg/min)


Secondary Outcome Measures :
  1. 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. Whole-Body Lean Mass [ Time Frame: 2 Weeks ]
    Measured by DEXA (Kg)

  3. Body Fat percentage [ Time Frame: 2 Weeks ]
    Measured by DEXA

  4. Leg Lean Mass [ Time Frame: 2 Weeks ]
    Measured by DEXA (Kg)

  5. Handgrip Strength [ Time Frame: 2 Weeks ]
    Maximum voluntary contraction



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   65 Years to 85 Years   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03331679


Locations
Layout table for location information
United Kingdom
Medical School
Derby, United Kingdom, DE22 3DT
Sponsors and Collaborators
University of Nottingham
Layout table for additonal information
Responsible Party: University of Nottingham
ClinicalTrials.gov Identifier: NCT03331679    
Other Study ID Numbers: A12092016 amendment 4
First Posted: November 6, 2017    Key Record Dates
Last Update Posted: March 12, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No