NCT02167191

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2014

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2014

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

June 16, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 18, 2014

Completed
13 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2014

Completed
Last Updated

October 1, 2015

Status Verified

September 1, 2015

Enrollment Period

5 months

First QC Date

June 16, 2014

Last Update Submit

September 30, 2015

Conditions

Outcome Measures

Primary Outcomes (1)

  • VO2 peak

    31 days

Study Arms (1)

HIT

EXPERIMENTAL

High intensity interval training sessions on an cycle ergometer

Behavioral: HIT

Interventions

HITBEHAVIORAL

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

HIT

Eligibility Criteria

Age60 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Good health
  • Male and female
  • years old

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Nottingham

Derby, Derbyshire, DE22 3DT, United Kingdom

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 16, 2014

First Posted

June 18, 2014

Study Start

February 1, 2014

Primary Completion

July 1, 2014

Study Completion

August 1, 2014

Last Updated

October 1, 2015

Record last verified: 2015-09

Locations