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

May 3, 2019 updated by: University of Nottingham
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

48

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Derby, United Kingdom, DE22 3NE
        • University of Nottingham

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years to 85 years (Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
No intervention
Experimental: High Intensity Interval Training (HIIT)
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.
Other: HIIT
Other Names:
  • High intensity Interval training
Experimental: Isometric Handgrip (HOLD)
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
Other: HOLD
Other Names:
  • Isometric exercise
  • Isometric handgrip
Experimental: Remote Ischaemic Preconditioning (HUG)
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.
Other: HUG
Other Names:
  • Ischaemic preconditioning
  • Remote ischaemic preconditioning

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in resting diastolic blood pressure
Time Frame: 6 weeks
Measured using a ramp incremental exercise test on a cycle ergometer.
6 weeks
Ambulatory blood pressure
Time Frame: 6 weeks
Ambulatory blood pressure
6 weeks
V02 Peak
Time Frame: 6 weeks
Measured using a ramp incremental exercise test on a cycle ergometer.
6 weeks
Anaerobic threshold
Time Frame: 6 weeks
Measured using a ramp incremental exercise test on a cycle ergometer.
6 weeks
Body fat percentage
Time Frame: 6 weeks
Measured by dual energy X-ray absorptiometry
6 weeks
Total body lean mass
Time Frame: 6 weeks
Measured by dual energy X-ray absorptiometry
6 weeks
Change in common femoral artery blood flow
Time Frame: 6 weeks
Measured by duplex ultrasound on non-dominant leg in response to 6 unilateral leg extensions at 50% 1 repetition maximum
6 weeks
Change in Vastus lateralis microvascular blood flow
Time Frame: 6 weeks
Measured by contrast enhanced ultrasound on the dominant leg in response to 6 unilateral leg extensions at 50% 1 repetition maximum
6 weeks
Flow-mediated dilatation
Time Frame: 6 weeks
6 weeks
Heart rate recovery post exercise
Time Frame: 6 weeks
Change in heart rate after exercise from peak over time
6 weeks
Blood pressure recovery post exercise
Time Frame: 6 weeks
Change in blood pressure after exercise from peak over time
6 weeks
Area under concentration curve for serum Glucose
Time Frame: 6 weeks
Measured from a 3 hour oral glucose tolerance test
6 weeks
Area under concentration curve for serum Insulin
Time Frame: 6 weeks
Measured from a 3 hour oral glucose tolerance test
6 weeks
Matsuda Index of insulin sensitivity
Time Frame: 6 weeks
Measured from a 3 hour oral glucose tolerance test
6 weeks
Cederholm Index of insulin sensitivity
Time Frame: 6 weeks
Measured from a 3 hour oral glucose tolerance test
6 weeks
Homeostatic Model Assessment of Insulin Resistance
Time Frame: 6 weeks
Measured from fasting plasma samples, taken before a 3 hour oral glucose tolerance test
6 weeks
Fasting Serum Cholesterol
Time Frame: 6 weeks
6 weeks
Fasting serum triglyceride
Time Frame: 6 weeks
6 weeks
Time to failure, cycling at 50% maximum power achieved during CPET
Time Frame: 6 weeks
6 weeks
Handgrip maximum voluntary contraction
Time Frame: 6 weeks
Measured using a handgrip dynamometer
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Nottingham

Collaborators

The Royal College of Surgeons of England
The Dunhill Medical Trust

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 4, 2017

Primary Completion (Actual)

April 25, 2019

Study Completion (Anticipated)

August 1, 2019

Study Registration Dates

First Submitted

January 4, 2017

First Submitted That Met QC Criteria

January 10, 2017

First Posted (Estimate)

January 12, 2017

Study Record Updates

Last Update Posted (Actual)

May 7, 2019

Last Update Submitted That Met QC Criteria

May 3, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A12092016

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Hypertension

Clinical Trials on HIIT

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Hungary

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe