HIT Training in the Frail Elderly. (eHIT)

Improvements in Aerobic Performance Following a Four-week Period of High Intensity Interval Training in the Elderly.

This pilot study aims to investigate whether high intensity interval training can result in rapid improvements in physical fitness amongst the frail elderly (over 70 years old). Participants will undergo a wide range of physical fitness measures followed by a four week exercise protocol. Determination of improvement will be by repeated testing of the physical measures taken for baseline. The primary outcome measure will be anaerobic threshold. There will also be a subgroup of participants who will undergo muscle biopsy and D2O ingestion to allow an insight into the mechanistic basis behind exercise training response in this age group.

Study Overview

• Status: Completed
• Conditions: Exercise; Sarcopenia; Aged; Preoperative Care
• Intervention / Treatment: Behavioral: HIIT Device: ergometer

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Derbyshire
    • Derby, Derbyshire, United Kingdom, DE22 3DT
      • School of Graduate Entry Medicine, Royal Derby Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 70 years and older (Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Aged over 70 years.
• Sufficient mobility to be able to exercise on a static exercise bike.
• Availability for the entire trial period.
• Sufficient capacity to consent for the trial.

Exclusion Criteria:

• Participants under the age of 70 years.

Participants with a significant past medical history of:

• Myocardial infarction (within last 6 months)
• Unstable Angina
• Heart failure (NYHA class III/IV)
• Uncontrolled Hypertension (BP>160/100)
• Previous stroke/TIA
• Severe respiratory disease inc. known pulmonary hypertension(>25 mmHg), Forced -Expiratory Volume in 1 second <1.5l.
• Brittle asthma / exercise induced asthma
• Known cerebral aneurysm or abdominal aortic aneurysm.
• Cognitive impairment, which may reduce individuals' ability to provide informed consent.
• Inclusion in a recent study which included any form of exercise, taking a drug or ionising radiation.

Exclusion criteria pertaining specifically to muscle biopsies:

• Current use of anticoagulation (i.e. Warfarin/Clopidogrel/Rivaroxaban)
• Any pre-existing clotting disorders known to the patient (i.e. haemophilia).
• Family history of severe bleeding requiring medical intervention.
• Any musculoskeletal deformity or skin conditions making the taking of a biopsy unsuitable as deemed by the medical practitioner taking that sample.
• Lack of capacity to fully consent for the procedure.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: High intensity exercise training; HIT training protocol.	Behavioral: HIIT Device: ergometer; Supervised exercise training.; Other Names: High intensity interval training

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean anaerobic threshold improvement following 4 week HIT protocol.	Measured via cardiopulmonary exercise testing (mls/kg/min and absolute value L/kg). Pre-Post testing.	4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean VO2 peak improvement following 4 week HIT protocol.	Measured via cardiopulmonary exercise testing (mls/kg/min and absolute value L/kg). Pre-Post testing.	4 weeks
Muscle protein synthesis	Assessment of D2O evaluated muscle protein synthesis following HIT programme. Using mass spectrometry for analysis of stable isotope uptake during training program (arbitrary units).	4 weeks
Body composition	DXA changes in body composition (lean muscle mass (%), fat mass (%) and bone density g/cm3)) following a HIT programme	4 weeks
Muscle architecture	Ultrasound scans used to assess changes in lean muscle mass and architecture following a HIT programme (mm and % pennation angle change).	4 weeks
Feasibility	Determination of frail elderly patient adherence to HIT programme (number of scheduled sessions successfully completed within 28 days).	4 Weeks
Quality of life improvement	Quality of life questionnaires to measure subjective outcomes (EQ-5D questionnaire)	4 weeks
Daily Activity Level	Activity questionnaire to quantify habitual physical activity (IPAQ questionnaire)	4 weeks
Physical Activity Score	Subjective assessment of physical ability (DASI questionnaire)	4 weeks

Collaborators and Investigators

• Sponsor: University of Nottingham
• Investigators: Principal Investigator: John Williams, BSc MBChB FRCA PhD, Nottingham University

Study record dates

Study Major Dates

• Study Start: September 1, 2015
• Primary Completion (Actual): October 1, 2017
• Study Completion (Actual): April 1, 2018

Study Registration Dates

• First Submitted: September 21, 2015
• First Submitted That Met QC Criteria: April 28, 2017
• First Posted (Actual): May 3, 2017

Study Record Updates

• Last Update Posted (Actual): September 13, 2018
• Last Update Submitted That Met QC Criteria: September 12, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Neuromuscular Manifestations; Pathological Conditions, Anatomical; Muscular Atrophy; Atrophy; Sarcopenia
• Other Study ID Numbers: eHIT_Protocol