Exploring Time-efficient Strategies to Improve Fitness for Surgery in Older Adults
eHHH
1 other identifier
interventional
48
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2017
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 4, 2017
CompletedStudy Start
First participant enrolled
January 4, 2017
CompletedFirst Posted
Study publicly available on registry
January 12, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 25, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2019
CompletedMay 7, 2019
May 1, 2019
2.3 years
January 4, 2017
May 3, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
6 weeks
Secondary Outcomes (20)
Change in resting diastolic blood pressure
6 weeks
Ambulatory blood pressure
6 weeks
V02 Peak
6 weeks
Anaerobic threshold
6 weeks
Body fat percentage
6 weeks
- +15 more secondary outcomes
Study Arms (4)
High Intensity Interval Training (HIIT)
EXPERIMENTAL3 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)
EXPERIMENTAL3x 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)
EXPERIMENTAL3x 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 INTERVENTIONNo intervention
Interventions
Eligibility Criteria
You may qualify if:
- Healthy volunteer aged 65-85
You may not qualify if:
- 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),
- 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:
- +14 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Nottinghamlead
- The Royal College of Surgeons of Englandcollaborator
- The Dunhill Medical Trustcollaborator
Study Sites (1)
University Of Nottingham
Derby, DE22 3NE, United Kingdom
Related Publications (18)
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.
PMID: 25034910BACKGROUNDPhillips 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.
PMID: 25867865BACKGROUNDGonzalez-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.
PMID: 12591751BACKGROUNDSnowden 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.
PMID: 23665968BACKGROUNDIwasaki 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.
PMID: 12832429BACKGROUNDWilmore 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.
PMID: 11699041BACKGROUNDVollaard 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.
PMID: 19196912BACKGROUNDKraus 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.
PMID: 12421890BACKGROUNDSantos-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.
PMID: 25434012BACKGROUNDSeals 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.
PMID: 24855137BACKGROUNDKraus 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.
PMID: 11581566BACKGROUNDChurch 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.
PMID: 17507344BACKGROUNDPhillips 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.
PMID: 21998269BACKGROUNDMetcalfe 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.
PMID: 22124524BACKGROUNDGarg 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.
PMID: 25386422BACKGROUNDMillar PJ, McGowan CL, Cornelissen VA, Araujo CG, Swaine IL. Evidence for the role of isometric exercise training in reducing blood pressure: potential mechanisms and future directions. Sports Med. 2014 Mar;44(3):345-56. doi: 10.1007/s40279-013-0118-x.
PMID: 24174307BACKGROUNDJean-St-Michel E, Manlhiot C, Li J, Tropak M, Michelsen MM, Schmidt MR, McCrindle BW, Wells GD, Redington AN. Remote preconditioning improves maximal performance in highly trained athletes. Med Sci Sports Exerc. 2011 Jul;43(7):1280-6. doi: 10.1249/MSS.0b013e318206845d.
PMID: 21131871BACKGROUNDJones H, Hopkins N, Bailey TG, Green DJ, Cable NT, Thijssen DH. Seven-day remote ischemic preconditioning improves local and systemic endothelial function and microcirculation in healthy humans. Am J Hypertens. 2014 Jul;27(7):918-25. doi: 10.1093/ajh/hpu004. Epub 2014 Mar 13.
PMID: 24627443BACKGROUND
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 4, 2017
First Posted
January 12, 2017
Study Start
January 4, 2017
Primary Completion
April 25, 2019
Study Completion
August 1, 2019
Last Updated
May 7, 2019
Record last verified: 2019-05
Data Sharing
- IPD Sharing
- Will not share