Can 2 Weeks of High Intensity Interval Training in Healthy 65-85 Year-olds Improve Cardiorespiratory Fitness? (2WkHIT)

• ClinicalTrials.gov Identifier: NCT03331679
• Recruitment Status: Completed
• First Posted: November 6, 2017
• Last Update Posted: March 12, 2019
• Sponsor: University of Nottingham
• Information provided by (Responsible Party): University of Nottingham

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Cardiorespiratory Fitness	Behavioral: HIIT	Not Applicable

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

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 10 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Exploring Time Efficient Strategies to Improve Fitness for Surgery in Older Adults- Two Weeks HIIT
• Actual Study Start Date: January 23, 2018
• Actual Primary Completion Date: August 1, 2018
• Actual Study Completion Date: December 1, 2018

Arms and Interventions

Arm	Intervention/treatment
Experimental: 2 Wk HIIT; 2 weeks of High Intensity Interval Training	Behavioral: HIIT; 2 Weeks of High Intensity Interval Training on a Cycle ergometer

Outcome Measures

Primary Outcome Measures :

1. Anaerobic Threshold [ Time Frame: 2 weeks ]
   Anaerobic Threshold as measured at standard CPET conducted according to ATS/ACCP statement (measured in ml/Kg/min)

Secondary Outcome Measures :

1. VO2 Peak [ Time Frame: 2 Weeks ]
   Maximum volume of oxygen consumed at CPET conducted according to ATS/ACCP statement (measured in ml/Kg/min)
2. Whole-Body Lean Mass [ Time Frame: 2 Weeks ]
   Measured by DEXA (Kg)
3. Body Fat percentage [ Time Frame: 2 Weeks ]
   Measured by DEXA
4. Leg Lean Mass [ Time Frame: 2 Weeks ]
   Measured by DEXA (Kg)
5. Handgrip Strength [ Time Frame: 2 Weeks ]
   Maximum voluntary contraction

Eligibility Criteria

• Ages Eligible for Study: 65 Years to 85 Years (Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

Inclusion Criteria:

• Healthy Volunteer aged 65-85

Exclusion Criteria:

• 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),
• 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

Contacts and Locations

Locations

United Kingdom

Medical School

Derby, United Kingdom, DE22 3DT

Sponsors and Collaborators

University of Nottingham

More Information

• Responsible Party: University of Nottingham
• ClinicalTrials.gov Identifier: NCT03331679
• Other Study ID Numbers: A12092016 amendment 4
• First Posted: November 6, 2017
• Last Update Posted: March 12, 2019
• Last Verified: March 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No