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

March 8, 2019 updated by: University of Nottingham

Exploring Time Efficient Strategies to Improve Fitness for Surgery in Older Adults- Two Weeks HIIT

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.

Study Overview

Status

Completed

Intervention / Treatment

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

Interventional

Enrollment (Actual)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years to 85 years (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 23, 2018

Primary Completion (Actual)

August 1, 2018

Study Completion (Actual)

December 1, 2018

Study Registration Dates

First Submitted

October 27, 2017

First Submitted That Met QC Criteria

October 31, 2017

First Posted (Actual)

November 6, 2017

Study Record Updates

Last Update Posted (Actual)

March 12, 2019

Last Update Submitted That Met QC Criteria

March 8, 2019

Last Verified

March 1, 2019

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)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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