Cardiorespiratory Fitness2WkHITNCT03331679
Can 2 Weeks of High Intensity Interval Training in Healthy 65-85 Year-olds Improve Cardiorespiratory Fitness?
A study testing HIIT in people with Cardiorespiratory Fitness, run by University of Nottingham at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiorespiratory Fitness
- What is being tested?
- HIIT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 23 Jan 2018to 1 Dec 2018
- 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 65 to 85 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Healthy Volunteer aged 65-85
Who cannot join
- 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),
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Cardiorespiratory Fitness
- Being tested
- HIIT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HIITBehavioural
2 Weeks of High Intensity Interval Training on a Cycle ergometer
| Study group | Role | What they receive |
|---|---|---|
| 2 Wk HIIT | Experimental | 2 weeks of High Intensity Interval Training Receives: Behavioral: HIIT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anaerobic Threshold
Anaerobic Threshold as measured at standard CPET conducted according to ATS/ACCP statement (measured in ml/Kg/min)
Measured: 2 weeks
Secondary outcomes (5)
VO2 Peak
Maximum volume of oxygen consumed at CPET conducted according to ATS/ACCP statement (measured in ml/Kg/min)
Measured: 2 Weeks
Whole-Body Lean Mass
Measured by DEXA (Kg)
Measured: 2 Weeks
Body Fat percentage
Measured by DEXA
Measured: 2 Weeks
Leg Lean Mass
Measured by DEXA (Kg)
Measured: 2 Weeks
Handgrip Strength
Maximum voluntary contraction
Measured: 2 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2017
- Study start23 Jan 2018
- Primary completion1 Aug 2018
- Study completion1 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiorespiratory FitnessStudies of the same condition, open and under way.
- More trials run by University of NottinghamThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 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
- NCT03331679
- Sponsor's protocol ID
- A12092016 amendment 4
- Acronym
- 2WkHIT
- Status last verified
- Mar 2019
- First submitted
- 27 Oct 2017
- Last updated
- 12 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring Time Efficient Strategies to Improve Fitness for Surgery in Older Adults- Two Weeks HIIT
- ClinicalTrials.gov ID
- NCT03331679
- Acronym / sponsor ID
- 2WkHIT / A12092016 amendment 4
- Conditions
- Cardiorespiratory Fitness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of NottinghamUniversity, hospital or other
- Study start
- 23 Jan 2018 (actual)
- Primary completion
- 1 Aug 2018 (actual)
- Study completion
- 1 Dec 2018 (actual)
- First posted
- 6 Nov 2017 (actual)
- 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.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 2 Wk HIIT | Experimental | Behavioral: HIIT2 weeks of High Intensity Interval Training |
Who may qualify
- Ages
- 65 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- Healthy Volunteer aged 65-85
Key exclusion criteria (18 listed)
- Current participation in a formal exercise regime
- BMI < 18 or > 32 kg·m2
- Active cardiovascular disease:
- uncontrolled hypertension (BP > 160/100),
- angina,
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 |
|---|---|---|
| HIIT2 Weeks of High Intensity Interval Training on a Cycle ergometer | Behavioural | 2 Wk HIIT |
Primary outcome
Anaerobic Threshold
Time frame: 2 weeks
Anaerobic Threshold as measured at standard CPET conducted according to ATS/ACCP statement (measured in ml/Kg/min)
5 secondary outcomes
VO2 Peak
Time frame: 2 Weeks
Whole-Body Lean Mass
Time frame: 2 Weeks
Body Fat percentage
Time frame: 2 Weeks
Leg Lean Mass
Time frame: 2 Weeks
Handgrip Strength
Time frame: 2 Weeks
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 12 Mar 2019.
- Individual participant dataSharing planned: Undecided
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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 HIIT in people with Cardiorespiratory Fitness, 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 1 inclusion and 18 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 12 Mar 2019. 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?
Anaerobic Threshold (time frame: 2 weeks). 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 12 Mar 2019.