Perioperative HypertensioneHHHNCT03019146
Exploring Time-efficient Strategies to Improve Fitness for Surgery in Older Adults
A study testing HIIT, HOLD and HUG in people with Perioperative Hypertension and Hypertension, 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
- Perioperative Hypertension, Hypertension
- What is being tested?
- HIIT, HOLD and HUG
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 4 Jan 2017to 1 Aug 2019
- 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
- A BMI < 18 or > 32 kg·m2
- Active cardiovascular disease:
- uncontrolled hypertension (BP > 160/100),
- angina,
- heart failure (class III/IV),
Show all 29Show fewer
- 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
- Known sensitivity to Sonovue
Trial locations and contacts
1 site in 1 country.
About this study
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, namely: i) poor exercise tolerance, ii) "lack of time", iii) age-related mobility impairments, and iv) exercise resistance.
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. However, despite the potential benefits of HIIT, not least its 70-80% reduction in required time-commitment compared to current WHO guidelines, it does have limitations, particularly for an older population where physical (mobility/joint) and/or socio-economic (transport/gym access/equipment purchase) barriers may render it ineffective and/or unachievable.
Alternative interventions for prevention or treatment of age-associated vascular dysfunction could be provided by isometric handgrip training (IHG) or remote ischaemic pre-conditioning (RIPC), both of which have a similar low time-commitment compared to HIIT but are less strenuous, have potential as home-based interventions, and require only inexpensive equipment. IHG has been demonstrated to improve resting blood pressure in both normotensive and medicated hypertensive populations to a similar or greater extent as classic aerobic exercise training. However, the effects of IHG on other vascular (e.g. limb, brain and muscle microvascular blood flow) or cardio-respiratory parameters (VO2 max, heart rate (resting/recovery), exercise tolerance) have not been assessed. Similarly, although RIPC has recently been shown to improve maximal athletic cardio-respiratory performance and vascular function in young subjects, no work to date has explored the efficacy of chronic RIPC on indices of health or vascular function in older individuals.
Therefore, the aims of this project are to:
(i) Assess the efficacy of 6 weeks HIT, IHG and RIPC for improving indices of cardio-respiratory, vascular and metabolic function in older subjects as a means of improving fitness for surgery.
(ii) Explore the concept of "exercise resistance" in relation to HIT, IHG and RIPC by:
- Assessing if the same degree of response heterogeneity exists for the three time-efficient training modes employed in this study as has been reported for classic resistance and aerobic exercise training
- Assessing if a "non-responder" for one index (i.e., resting blood pressure or leg blood flow) is a non-responder for all other indices
- Conditions
- Perioperative Hypertension, Hypertension
- Being tested
- HIIT, HOLD, HUG
- Keywords
- Prehabilitation
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HIITOther
Also called High intensity Interval training
HOLDOther
Also called Isometric exercise, Isometric handgrip
HUGOther
Also called Remote ischaemic preconditioning, Ischaemic preconditioning
| Study group | Role | What they receive |
|---|---|---|
| High Intensity Interval Training (HIIT) | Experimental | 3 x 15 minute sessions per week for 6 weeks. Sessions include 5x intervals of cycling at 110% of Wmax derived from CPET, interspersed with 90s rest periods of unloaded cycling. Receives: Other: HIIT |
| Isometric Handgrip (HOLD) | Experimental | 3x 15 minute sessions per week for 6 weeks Sessions include 4x intervals of 2minutes isometric handgrip contraction of dominant arm at 30% Maximal voluntary contraction, interspersed with 2minute rest periods Receives: Other: HOLD |
| Remote Ischaemic Preconditioning (HUG) | Experimental | 3x 15 minute sessions per week for 6 weeks. Sessions include 3x intervals of 3 minutes of arm ischaemia (blood pressure cuff inflated to 200mmHg on dominant arm) interspersed with 3 minute rest periods. Receives: Other: HUG |
| Control | No intervention | No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in resting systolic blood pressure
Measured in seated position using oscillometry, mean value of 3 recordings, measured according to British Society of Hypertension Guidelines 2013.
Measured: 6 weeks
Secondary outcomes (20)
Change in resting diastolic blood pressure
Measured using a ramp incremental exercise test on a cycle ergometer.
Measured: 6 weeks
Ambulatory blood pressure
Ambulatory blood pressure
Measured: 6 weeks
V02 Peak
Measured using a ramp incremental exercise test on a cycle ergometer.
Measured: 6 weeks
Anaerobic threshold
Measured using a ramp incremental exercise test on a cycle ergometer.
Measured: 6 weeks
Body fat percentage
Measured by dual energy X-ray absorptiometry
Measured: 6 weeks
Total body lean mass
Measured by dual energy X-ray absorptiometry
Measured: 6 weeks
Change in common femoral artery blood flow
Measured by duplex ultrasound on non-dominant leg in response to 6 unilateral leg extensions at 50% 1 repetition maximum
Measured: 6 weeks
Change in Vastus lateralis microvascular blood flow
Measured by contrast enhanced ultrasound on the dominant leg in response to 6 unilateral leg extensions at 50% 1 repetition maximum
Measured: 6 weeks
Flow-mediated dilatation
Measured: 6 weeks
Heart rate recovery post exercise
Change in heart rate after exercise from peak over time
Measured: 6 weeks
Blood pressure recovery post exercise
Change in blood pressure after exercise from peak over time
Measured: 6 weeks
Area under concentration curve for serum Glucose
Measured from a 3 hour oral glucose tolerance test
Measured: 6 weeks
Area under concentration curve for serum Insulin
Measured from a 3 hour oral glucose tolerance test
Measured: 6 weeks
Matsuda Index of insulin sensitivity
Measured from a 3 hour oral glucose tolerance test
Measured: 6 weeks
Cederholm Index of insulin sensitivity
Measured from a 3 hour oral glucose tolerance test
Measured: 6 weeks
Homeostatic Model Assessment of Insulin Resistance
Measured from fasting plasma samples, taken before a 3 hour oral glucose tolerance test
Measured: 6 weeks
Fasting Serum Cholesterol
Measured: 6 weeks
Fasting serum triglyceride
Measured: 6 weeks
Time to failure, cycling at 50% maximum power achieved during CPET
Measured: 6 weeks
Handgrip maximum voluntary contraction
Measured using a handgrip dynamometer
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2017 (estimated)
- Study start4 Jan 2017
- Primary completion25 Apr 2019
- Study completion1 Aug 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for Perioperative HypertensionStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nottingham
- Sponsor type
- University, hospital or other
- Collaborators
- The Royal College of Surgeons of England, The Dunhill Medical Trust
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03019146
- Sponsor's protocol ID
- A12092016
- Acronym
- eHHH
- Status last verified
- May 2019
- First submitted
- 4 Jan 2017
- Last updated
- 7 May 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
LaRocca TJ, Hearon CM Jr, Henson GD, Seals DR. Mitochondrial quality control and age-associated arterial stiffening. Exp Gerontol. 2014 Oct;58:78-82. doi: 10.1016/j.exger.2014.07.008. Epub 2014 Jul 14.
PubMed 25034910Phillips BE, Atherton PJ, Varadhan K, Limb MC, Wilkinson DJ, Sjoberg KA, Smith K, Williams JP. The effects of resistance exercise training on macro- and micro-circulatory responses to feeding and skeletal muscle protein anabolism in older men. J Physiol. 2015 Jun 15;593(12):2721-34. doi: 10.1113/JP270343. Epub 2015 May 14.
PubMed 25867865Gonzalez-Alonso J, Calbet JA. Reductions in systemic and skeletal muscle blood flow and oxygen delivery limit maximal aerobic capacity in humans. Circulation. 2003 Feb 18;107(6):824-30. doi: 10.1161/01.cir.0000049746.29175.3f.
PubMed 12591751Snowden CP, Prentis J, Jacques B, Anderson H, Manas D, Jones D, Trenell M. Cardiorespiratory fitness predicts mortality and hospital length of stay after major elective surgery in older people. Ann Surg. 2013 Jun;257(6):999-1004. doi: 10.1097/SLA.0b013e31828dbac2.
PubMed 23665968Iwasaki K, Zhang R, Zuckerman JH, Levine BD. Dose-response relationship of the cardiovascular adaptation to endurance training in healthy adults: how much training for what benefit? J Appl Physiol (1985). 2003 Oct;95(4):1575-83. doi: 10.1152/japplphysiol.00482.2003. Epub 2003 Jun 27.
PubMed 12832429Wilmore JH, Green JS, Stanforth PR, Gagnon J, Rankinen T, Leon AS, Rao DC, Skinner JS, Bouchard C. Relationship of changes in maximal and submaximal aerobic fitness to changes in cardiovascular disease and non-insulin-dependent diabetes mellitus risk factors with endurance training: the HERITAGE Family Study. Metabolism. 2001 Nov;50(11):1255-63. doi: 10.1053/meta.2001.27214.
PubMed 11699041Vollaard NB, Constantin-Teodosiu D, Fredriksson K, Rooyackers O, Jansson E, Greenhaff PL, Timmons JA, Sundberg CJ. Systematic analysis of adaptations in aerobic capacity and submaximal energy metabolism provides a unique insight into determinants of human aerobic performance. J Appl Physiol (1985). 2009 May;106(5):1479-86. doi: 10.1152/japplphysiol.91453.2008. Epub 2009 Feb 5.
PubMed 19196912Kraus WE, Houmard JA, Duscha BD, Knetzger KJ, Wharton MB, McCartney JS, Bales CW, Henes S, Samsa GP, Otvos JD, Kulkarni KR, Slentz CA. Effects of the amount and intensity of exercise on plasma lipoproteins. N Engl J Med. 2002 Nov 7;347(19):1483-92. doi: 10.1056/NEJMoa020194.
PubMed 12421890Santos-Parker JR, LaRocca TJ, Seals DR. Aerobic exercise and other healthy lifestyle factors that influence vascular aging. Adv Physiol Educ. 2014 Dec;38(4):296-307. doi: 10.1152/advan.00088.2014.
PubMed 25434012Seals DR. Edward F. Adolph Distinguished Lecture: The remarkable anti-aging effects of aerobic exercise on systemic arteries. J Appl Physiol (1985). 2014 Sep 1;117(5):425-39. doi: 10.1152/japplphysiol.00362.2014. Epub 2014 May 22.
PubMed 24855137Kraus WE, Torgan CE, Duscha BD, Norris J, Brown SA, Cobb FR, Bales CW, Annex BH, Samsa GP, Houmard JA, Slentz CA. Studies of a targeted risk reduction intervention through defined exercise (STRRIDE). Med Sci Sports Exerc. 2001 Oct;33(10):1774-84. doi: 10.1097/00005768-200110000-00025.
PubMed 11581566Church TS, Earnest CP, Skinner JS, Blair SN. Effects of different doses of physical activity on cardiorespiratory fitness among sedentary, overweight or obese postmenopausal women with elevated blood pressure: a randomized controlled trial. JAMA. 2007 May 16;297(19):2081-91. doi: 10.1001/jama.297.19.2081.
PubMed 17507344Phillips B, Williams J, Atherton P, Smith K, Hildebrandt W, Rankin D, Greenhaff P, Macdonald I, Rennie MJ. Resistance exercise training improves age-related declines in leg vascular conductance and rejuvenates acute leg blood flow responses to feeding and exercise. J Appl Physiol (1985). 2012 Feb;112(3):347-53. doi: 10.1152/japplphysiol.01031.2011. Epub 2011 Oct 13.
PubMed 21998269Metcalfe RS, Babraj JA, Fawkner SG, Vollaard NB. Towards the minimal amount of exercise for improving metabolic health: beneficial effects of reduced-exertion high-intensity interval training. Eur J Appl Physiol. 2012 Jul;112(7):2767-75. doi: 10.1007/s00421-011-2254-z. Epub 2011 Nov 29.
PubMed 22124524Garg R, Malhotra V, Kumar A, Dhar U, Tripathi Y. Effect of isometric handgrip exercise training on resting blood pressure in normal healthy adults. J Clin Diagn Res. 2014 Sep;8(9):BC08-10. doi: 10.7860/JCDR/2014/8908.4850. Epub 2014 Sep 20.
PubMed 25386422
Study at a glance
From the registry record, last updated by the sponsor on 7 May 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
- ClinicalTrials.gov ID
- NCT03019146
- Acronym / sponsor ID
- eHHH / A12092016
- Conditions
- Perioperative Hypertension, Hypertension
- Keywords
- Prehabilitation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (actual)
- Lead sponsor
- University of NottinghamUniversity, hospital or other
- Collaborators
- The Royal College of Surgeons of England, The Dunhill Medical Trust
- Study start
- 4 Jan 2017 (actual)
- Primary completion
- 25 Apr 2019 (actual)
- Study completion
- 1 Aug 2019 (estimated)
- First posted
- 12 Jan 2017 (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.
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, namely: i) poor exercise tolerance, ii) "lack of time", iii) age-related mobility impairments, and iv) exercise resistance.
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. However, despite the potential benefits of HIIT, not least its 70-80% reduction in required time-commitment compared to current WHO guidelines, it does have limitations, particularly for an older population where physical (mobility/joint) and/or socio-economic (transport/gym access/equipment purchase) barriers may render it ineffective and/or unachievable.
Alternative interventions for prevention or treatment of age-associated vascular dysfunction could be provided by isometric handgrip training (IHG) or remote ischaemic pre-conditioning (RIPC), both of which have a similar low time-commitment compared to HIIT but are less strenuous, have potential as home-based interventions, and require only inexpensive equipment. IHG has been demonstrated to improve resting blood pressure in both normotensive and medicated hypertensive populations to a similar or greater extent as classic aerobic exercise training. However, the effects of IHG on other vascular (e.g. limb, brain and muscle microvascular blood flow) or cardio-respiratory parameters (VO2 max, heart rate (resting/recovery), exercise tolerance) have not been assessed. Similarly, although RIPC has recently been shown to improve maximal athletic cardio-respiratory performance and vascular function in young subjects, no work to date has explored the efficacy of chronic RIPC on indices of health or vascular function in older individuals.
Therefore, the aims of this project are to:
(i) Assess the efficacy of 6 weeks HIT, IHG and RIPC for improving indices of cardio-respiratory, vascular and metabolic function in older subjects as a means of improving fitness for surgery.
(ii) Explore the concept of "exercise resistance" in relation to HIT, IHG and RIPC by:
- Assessing if the same degree of response heterogeneity exists for the three time-efficient training modes employed in this study as has been reported for classic resistance and aerobic exercise training
- Assessing if a "non-responder" for one index (i.e., resting blood pressure or leg blood flow) is a non-responder for all other indices
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| High Intensity Interval Training (HIIT) | Experimental | Other: HIIT3 x 15 minute sessions per week for 6 weeks. Sessions include 5x intervals of cycling at 110% of Wmax derived from CPET, interspersed with 90s rest periods of unloaded cycling. |
| Isometric Handgrip (HOLD) | Experimental | Other: HOLD3x 15 minute sessions per week for 6 weeks Sessions include 4x intervals of 2minutes isometric handgrip contraction of dominant arm at 30% Maximal voluntary contraction, interspersed with 2minute rest periods |
| Remote Ischaemic Preconditioning (HUG) | Experimental | Other: HUG3x 15 minute sessions per week for 6 weeks. Sessions include 3x intervals of 3 minutes of arm ischaemia (blood pressure cuff inflated to 200mmHg on dominant arm) interspersed with 3 minute rest periods. |
| Control | No intervention | –No intervention |
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 (29 listed)
- • Current participation in a formal exercise regime
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 |
|---|---|---|
| HIITAlso: High intensity Interval training | Other | High Intensity Interval Training (HIIT) |
| HOLDAlso: Isometric exercise, Isometric handgrip | Other | Isometric Handgrip (HOLD) |
| HUGAlso: Remote ischaemic preconditioning, Ischaemic preconditioning | Other | Remote Ischaemic Preconditioning (HUG) |
Primary outcome
Change in resting systolic blood pressure
Time frame: 6 weeks
Measured in seated position using oscillometry, mean value of 3 recordings, measured according to British Society of Hypertension Guidelines 2013.
20 secondary outcomes
Change in resting diastolic blood pressure
Time frame: 6 weeks
Ambulatory blood pressure
Time frame: 6 weeks
V02 Peak
Time frame: 6 weeks
Anaerobic threshold
Time frame: 6 weeks
Body fat percentage
Time frame: 6 weeks
Total body lean mass
Time frame: 6 weeks
Change in common femoral artery blood flow
Time frame: 6 weeks
Change in Vastus lateralis microvascular blood flow
Time frame: 6 weeks
Flow-mediated dilatation
Time frame: 6 weeks
Heart rate recovery post exercise
Time frame: 6 weeks
Blood pressure recovery post exercise
Time frame: 6 weeks
Area under concentration curve for serum Glucose
Time frame: 6 weeks
Area under concentration curve for serum Insulin
Time frame: 6 weeks
Matsuda Index of insulin sensitivity
Time frame: 6 weeks
Cederholm Index of insulin sensitivity
Time frame: 6 weeks
Homeostatic Model Assessment of Insulin Resistance
Time frame: 6 weeks
Fasting Serum Cholesterol
Time frame: 6 weeks
Fasting serum triglyceride
Time frame: 6 weeks
Time to failure, cycling at 50% maximum power achieved during CPET
Time frame: 6 weeks
Handgrip maximum voluntary contraction
Time frame: 6 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2019.
- Background: PubMed 25034910LaRocca TJ, Hearon CM Jr, Henson GD, Seals DR. Mitochondrial quality control and age-associated arterial stiffening. Exp Gerontol. 2014 Oct;58:78-82. doi: 10.1016/j.exger.2014.07.008. Epub 2014 Jul 14.
- Background: PubMed 25867865Phillips BE, Atherton PJ, Varadhan K, Limb MC, Wilkinson DJ, Sjoberg KA, Smith K, Williams JP. The effects of resistance exercise training on macro- and micro-circulatory responses to feeding and skeletal muscle protein anabolism in older men. J Physiol. 2015 Jun 15;593(12):2721-34. doi: 10.1113/JP270343. Epub 2015 May 14.
- Background: PubMed 12591751Gonzalez-Alonso J, Calbet JA. Reductions in systemic and skeletal muscle blood flow and oxygen delivery limit maximal aerobic capacity in humans. Circulation. 2003 Feb 18;107(6):824-30. doi: 10.1161/01.cir.0000049746.29175.3f.
- Background: PubMed 23665968Snowden CP, Prentis J, Jacques B, Anderson H, Manas D, Jones D, Trenell M. Cardiorespiratory fitness predicts mortality and hospital length of stay after major elective surgery in older people. Ann Surg. 2013 Jun;257(6):999-1004. doi: 10.1097/SLA.0b013e31828dbac2.
- Background: PubMed 12832429Iwasaki K, Zhang R, Zuckerman JH, Levine BD. Dose-response relationship of the cardiovascular adaptation to endurance training in healthy adults: how much training for what benefit? J Appl Physiol (1985). 2003 Oct;95(4):1575-83. doi: 10.1152/japplphysiol.00482.2003. Epub 2003 Jun 27.
- Background: PubMed 11699041Wilmore JH, Green JS, Stanforth PR, Gagnon J, Rankinen T, Leon AS, Rao DC, Skinner JS, Bouchard C. Relationship of changes in maximal and submaximal aerobic fitness to changes in cardiovascular disease and non-insulin-dependent diabetes mellitus risk factors with endurance training: the HERITAGE Family Study. Metabolism. 2001 Nov;50(11):1255-63. doi: 10.1053/meta.2001.27214.
- Background: PubMed 19196912Vollaard NB, Constantin-Teodosiu D, Fredriksson K, Rooyackers O, Jansson E, Greenhaff PL, Timmons JA, Sundberg CJ. Systematic analysis of adaptations in aerobic capacity and submaximal energy metabolism provides a unique insight into determinants of human aerobic performance. J Appl Physiol (1985). 2009 May;106(5):1479-86. doi: 10.1152/japplphysiol.91453.2008. Epub 2009 Feb 5.
- Background: PubMed 12421890Kraus WE, Houmard JA, Duscha BD, Knetzger KJ, Wharton MB, McCartney JS, Bales CW, Henes S, Samsa GP, Otvos JD, Kulkarni KR, Slentz CA. Effects of the amount and intensity of exercise on plasma lipoproteins. N Engl J Med. 2002 Nov 7;347(19):1483-92. doi: 10.1056/NEJMoa020194.
- Background: PubMed 25434012Santos-Parker JR, LaRocca TJ, Seals DR. Aerobic exercise and other healthy lifestyle factors that influence vascular aging. Adv Physiol Educ. 2014 Dec;38(4):296-307. doi: 10.1152/advan.00088.2014.
- Background: PubMed 24855137Seals DR. Edward F. Adolph Distinguished Lecture: The remarkable anti-aging effects of aerobic exercise on systemic arteries. J Appl Physiol (1985). 2014 Sep 1;117(5):425-39. doi: 10.1152/japplphysiol.00362.2014. Epub 2014 May 22.
- Background: PubMed 11581566Kraus WE, Torgan CE, Duscha BD, Norris J, Brown SA, Cobb FR, Bales CW, Annex BH, Samsa GP, Houmard JA, Slentz CA. Studies of a targeted risk reduction intervention through defined exercise (STRRIDE). Med Sci Sports Exerc. 2001 Oct;33(10):1774-84. doi: 10.1097/00005768-200110000-00025.
- Background: PubMed 17507344Church TS, Earnest CP, Skinner JS, Blair SN. Effects of different doses of physical activity on cardiorespiratory fitness among sedentary, overweight or obese postmenopausal women with elevated blood pressure: a randomized controlled trial. JAMA. 2007 May 16;297(19):2081-91. doi: 10.1001/jama.297.19.2081.
- Office for National Statistics; Population Ageing in the United Kingdom, its Constituent Countries and the European UnionLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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, HOLD and HUG in people with Perioperative Hypertension and Hypertension, 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 29 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: status not confirmed, as of the sponsor's last update on 7 May 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?
Results are not available in the source record.
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?
Change in resting systolic blood pressure (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03019146, which also lists 18 linked publications.
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 7 May 2019.