HIT Training in the Frail Elderly.

Sarcopenia Clinical Trial

— eHIT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03138265
• Other study ID #: eHIT_Protocol
• Status: Completed
• Phase: N/A
• Start date: September 2015
• Est. completion date: April 2018

Study information

• Verified date: September 2018
• Source: University of Nottingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: April 2018
• Est. primary completion date: October 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 70 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Aged
• Exercise
• Preoperative Care
• Sarcopenia

Intervention

Behavioral:
• HIIT Device: ergometer
Supervised exercise training.

Locations

Country	Name	City	State
United Kingdom	School of Graduate Entry Medicine, Royal Derby Hospital	Derby	Derbyshire

Sponsors (1)

Lead Sponsor	Collaborator
University of Nottingham

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Body composition	DXA changes in body composition (lean muscle mass (%), fat mass (%) and bone density g/cm3)) following a HIT programme	4 weeks
Secondary	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
Secondary	Feasibility	Determination of frail elderly patient adherence to HIT programme (number of scheduled sessions successfully completed within 28 days).	4 Weeks
Secondary	Quality of life improvement	Quality of life questionnaires to measure subjective outcomes (EQ-5D questionnaire)	4 weeks
Secondary	Daily Activity Level	Activity questionnaire to quantify habitual physical activity (IPAQ questionnaire)	4 weeks
Secondary	Physical Activity Score	Subjective assessment of physical ability (DASI questionnaire)	4 weeks