HIT Training in the Frail Elderly. (eHIT)

September 12, 2018 updated by: University of Nottingham

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
32

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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
    • Derbyshire
      • Derby, Derbyshire, United Kingdom, DE22 3DT
        • School of Graduate Entry Medicine, Royal Derby Hospital

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Mean anaerobic threshold improvement following 4 week HIT protocol.
Time Frame: 4 weeks
Measured via cardiopulmonary exercise testing (mls/kg/min and absolute value L/kg). Pre-Post testing.
4 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Mean VO2 peak improvement following 4 week HIT protocol.
Time Frame: 4 weeks
Measured via cardiopulmonary exercise testing (mls/kg/min and absolute value L/kg). Pre-Post testing.
4 weeks
Muscle protein synthesis
Time Frame: 4 weeks
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
Time Frame: 4 weeks
DXA changes in body composition (lean muscle mass (%), fat mass (%) and bone density g/cm3)) following a HIT programme
4 weeks
Muscle architecture
Time Frame: 4 weeks
Ultrasound scans used to assess changes in lean muscle mass and architecture following a HIT programme (mm and % pennation angle change).
4 weeks
Feasibility
Time Frame: 4 Weeks
Determination of frail elderly patient adherence to HIT programme (number of scheduled sessions successfully completed within 28 days).
4 Weeks
Quality of life improvement
Time Frame: 4 weeks
Quality of life questionnaires to measure subjective outcomes (EQ-5D questionnaire)
4 weeks
Daily Activity Level
Time Frame: 4 weeks
Activity questionnaire to quantify habitual physical activity (IPAQ questionnaire)
4 weeks
Physical Activity Score
Time Frame: 4 weeks
Subjective assessment of physical ability (DASI questionnaire)
4 weeks

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Nottingham

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: John Williams, BSc MBChB FRCA PhD, Nottingham University

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 21, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 28, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 3, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 13, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 12, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • eHIT_Protocol

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.

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