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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02167191
Other study ID # HIT
Secondary ID
Status Completed
Phase N/A
First received June 16, 2014
Last updated September 30, 2015
Start date February 2014
Est. completion date August 2014

Study information

Verified date September 2015
Source University of Nottingham
Contact n/a
Is FDA regulated No
Health authority United Kingdom: Research Ethics Committee
Study type Interventional

Clinical Trial Summary

It is widely known that exercise improves general fitness and that fitter patients recover more easily from illness and surgery. Conversely, unfit patients have a significantly higher morbidity and mortality after surgery and a longer inpatient stay. This will become increasingly important in an aging population as baseline fitness generally declines with age.

One method of improving cardiovascular fitness is by using low intensity endurance training programmes, a disadvantage of these it that they can take several months to show improvement. High intensity interval training (HIT) programmes that use short episodes of high intensity exercise have also been shown to improve fitness. These HIT programmes have also shown improvement in functional capacity and quality of life in patients with chronic disease. An advantage of HIT is that improvements in fitness may occur in a shorter time than traditional endurance training. It is also known that HIT can give superior gains over endurance training.

The primary aim of this study is to determine whether an improvement in aerobic fitness, as judged by a 2ml/kg/min increase in VO2peak, can be achieved within 31 days via a HIT programme, in a group of healthy elderly volunteers.

As a secondary aim we will assess whether this programme would be acceptable to the group studied, through determination of subject compliance and adherence to the training programme.


Recruitment information / eligibility

Status Completed
Enrollment 24
Est. completion date August 2014
Est. primary completion date July 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 60 Years to 75 Years
Eligibility Inclusion Criteria:

- Good health

- Male and female

- 60 -75 years old

Exclusion Criteria:

- Uncontrolled hypertension (BP > 140/100)

- Angina

- Heart failure (NYHA class III/IV)

- Cardiac arrthymias

- Right to left cardiac shunt

- Recent cardiac event

- Previous stroke/TIA

- Aneurysm (large vessel or intracranial)

- Severe respiratory disease including pulmonary hypertension

- COPD/asthma with an FEV1 less than 1.5 l

- Inclusion into any other research study in the last three months which involved: taking a drug; being paid a disturbance allowance; having an invasive procedure or exposure to ionising radiation

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science


Intervention

Behavioral:
HIT
12 sessions of HIT exercise in 31 days on a stationary cycle ergometer

Locations

Country Name City State
United Kingdom University of Nottingham Derby Derbyshire

Sponsors (1)

Lead Sponsor Collaborator
University of Nottingham

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary VO2 peak 31 days No
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