Interval TrainingHITNCT02167191
HIT in the Healthy Elderly Population
A study testing HIT in people with Interval Training and Pre Operative Exercise, run by University of Nottingham at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 60 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Interval Training, Pre Operative Exercise, Prehabilitation
- What is being tested?
- HIT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Feb 2014to Aug 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Good health
- Male and female
- 60 -75 years old
Who cannot join
- Uncontrolled hypertension (BP > 140/100)
- Angina
- Heart failure (NYHA class III/IV)
- Cardiac arrthymias
- Right to left cardiac shunt
- Recent cardiac event
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University of Nottingham
Derby, Derbyshire, DE22 3DT
About this study
Official title: Determining the Effectiveness of a High Intensity Interval Training Exercise Programme in the Healthy, Elderly Population
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.
Read more
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.
- Conditions
- Interval Training, Pre Operative Exercise, Prehabilitation, Elderly
- Being tested
- HIT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HITBehavioural
12 sessions of HIT exercise in 31 days on a stationary cycle ergometer
| Study group | Role | What they receive |
|---|---|---|
| HIT | Experimental | High intensity interval training sessions on an cycle ergometer Receives: Behavioral: HIT |
What is being measured
The primary outcome is the main question the study is designed to answer.
VO2 peak
Measured: 31 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2014 (estimated)
- Study startFeb 2014
- Primary completionJul 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Interval TrainingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nottingham
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02167191
- Sponsor's protocol ID
- HIT
- Acronym
- HIT
- Status last verified
- Sep 2015
- First submitted
- 16 Jun 2014
- Last updated
- 1 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determining the Effectiveness of a High Intensity Interval Training Exercise Programme in the Healthy, Elderly Population
- ClinicalTrials.gov ID
- NCT02167191
- Acronym / sponsor ID
- HIT / HIT
- Conditions
- Interval Training, Pre Operative Exercise, Prehabilitation, Elderly
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of NottinghamUniversity, hospital or other
- Study start
- Feb 2014
- Primary completion
- Jul 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 18 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HIT | Experimental | Behavioral: HITHigh intensity interval training sessions on an cycle ergometer |
Who may qualify
- Ages
- 60 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Good health
- Male and female
- 60 -75 years old
Key exclusion criteria (11 listed)
- Uncontrolled hypertension (BP > 140/100)
- Angina
- Heart failure (NYHA class III/IV)
- Cardiac arrthymias
- Right to left cardiac shunt
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HIT12 sessions of HIT exercise in 31 days on a stationary cycle ergometer | Behavioural | HIT |
Primary outcome
VO2 peak
Time frame: 31 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HIT in people with Interval Training and Pre Operative Exercise, run by University of Nottingham at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
VO2 peak (time frame: 31 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2015.