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Exploring Time-efficient Strategies to Improve Fitness for Surgery in Older Adults

Not Applicable
Conditions
Hypertension
Perioperative Hypertension
Interventions
Other: HIIT
Other: HOLD
Other: HUG
Registration Number
NCT03019146
Lead Sponsor
University of Nottingham
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.

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:

1. 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

2. 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

Recruitment & Eligibility

Status
UNKNOWN
Sex
All
Target Recruitment
48
Inclusion Criteria
  • Healthy volunteer aged 65-85
Exclusion Criteria
  • • 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:

      • 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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
High Intensity Interval Training (HIIT)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)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)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.
Primary Outcome Measures
NameTimeMethod
Change in resting systolic blood pressure6 weeks

Measured in seated position using oscillometry, mean value of 3 recordings, measured according to British Society of Hypertension Guidelines 2013.

Secondary Outcome Measures
NameTimeMethod
Ambulatory blood pressure6 weeks

Ambulatory blood pressure

V02 Peak6 weeks

Measured using a ramp incremental exercise test on a cycle ergometer.

Area under concentration curve for serum Glucose6 weeks

Measured from a 3 hour oral glucose tolerance test

Matsuda Index of insulin sensitivity6 weeks

Measured from a 3 hour oral glucose tolerance test

Cederholm Index of insulin sensitivity6 weeks

Measured from a 3 hour oral glucose tolerance test

Homeostatic Model Assessment of Insulin Resistance6 weeks

Measured from fasting plasma samples, taken before a 3 hour oral glucose tolerance test

Fasting Serum Cholesterol6 weeks
Body fat percentage6 weeks

Measured by dual energy X-ray absorptiometry

Change in common femoral artery blood flow6 weeks

Measured by duplex ultrasound on non-dominant leg in response to 6 unilateral leg extensions at 50% 1 repetition maximum

Heart rate recovery post exercise6 weeks

Change in heart rate after exercise from peak over time

Area under concentration curve for serum Insulin6 weeks

Measured from a 3 hour oral glucose tolerance test

Fasting serum triglyceride6 weeks
Change in resting diastolic blood pressure6 weeks

Measured using a ramp incremental exercise test on a cycle ergometer.

Flow-mediated dilatation6 weeks
Anaerobic threshold6 weeks

Measured using a ramp incremental exercise test on a cycle ergometer.

Total body lean mass6 weeks

Measured by dual energy X-ray absorptiometry

Change in Vastus lateralis microvascular blood flow6 weeks

Measured by contrast enhanced ultrasound on the dominant leg in response to 6 unilateral leg extensions at 50% 1 repetition maximum

Blood pressure recovery post exercise6 weeks

Change in blood pressure after exercise from peak over time

Time to failure, cycling at 50% maximum power achieved during CPET6 weeks
Handgrip maximum voluntary contraction6 weeks

Measured using a handgrip dynamometer

Trial Locations

Locations (1)

University Of Nottingham

🇬🇧

Derby, United Kingdom

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