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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03138265
Other study ID # eHIT_Protocol
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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