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HIT Training in the Frail Elderly. (eHIT)

Primary Purpose

Sarcopenia, Aged, Exercise

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
HIIT Device: ergometer
Sponsored by
University of Nottingham
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Sarcopenia

Eligibility Criteria

70 Years - undefined (Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • School of Graduate Entry Medicine, Royal Derby Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

High intensity exercise training

Arm Description

HIT training protocol.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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).
Body composition
DXA changes in body composition (lean muscle mass (%), fat mass (%) and bone density g/cm3)) following a HIT programme
Muscle architecture
Ultrasound scans used to assess changes in lean muscle mass and architecture following a HIT programme (mm and % pennation angle change).
Feasibility
Determination of frail elderly patient adherence to HIT programme (number of scheduled sessions successfully completed within 28 days).
Quality of life improvement
Quality of life questionnaires to measure subjective outcomes (EQ-5D questionnaire)
Daily Activity Level
Activity questionnaire to quantify habitual physical activity (IPAQ questionnaire)
Physical Activity Score
Subjective assessment of physical ability (DASI questionnaire)

Full Information

First Posted
September 21, 2015
Last Updated
September 12, 2018
Sponsor
University of Nottingham
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1. Study Identification

Unique Protocol Identification Number
NCT03138265
Brief Title
HIT Training in the Frail Elderly.
Acronym
eHIT
Official Title
Improvements in Aerobic Performance Following a Four-week Period of High Intensity Interval Training in the Elderly.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
September 2015 (undefined)
Primary Completion Date
October 2017 (Actual)
Study Completion Date
April 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Nottingham

4. Oversight

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sarcopenia, Aged, Exercise, Preoperative Care

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Single
Allocation
N/A
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John Williams, BSc MBChB FRCA PhD
Organizational Affiliation
Nottingham University
Official's Role
Principal Investigator
Facility Information:
Facility Name
School of Graduate Entry Medicine, Royal Derby Hospital
City
Derby
State/Province
Derbyshire
ZIP/Postal Code
DE22 3DT
Country
United Kingdom

12. IPD Sharing Statement

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HIT Training in the Frail Elderly.

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