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Completed

NCT Number: NCT03138265

HIT Training in the Frail 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.

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Key information

Conditions

Sarcopenia Aged Atrophy Behavior Exercise Motor Activity Muscular Atrophy Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Preoperative Care Signs and Symptoms

Age range

70 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

School of Graduate Entry Medicine, Royal Derby Hospital

Derby, Derbyshire, DE22 3DT, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

HIIT Device: ergometer

Behavioral

Supervised exercise training.

Other names: High intensity interval training

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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).

  3. 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. 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).

  5. Feasibility

    Time frame: 4 Weeks

    Determination of frail elderly patient adherence to HIT programme (number of scheduled sessions successfully completed within 28 days).

  6. Quality of life improvement

    Time frame: 4 weeks

    Quality of life questionnaires to measure subjective outcomes (EQ-5D questionnaire)

  7. Daily Activity Level

    Time frame: 4 weeks

    Activity questionnaire to quantify habitual physical activity (IPAQ questionnaire)

  8. Physical Activity Score

    Time frame: 4 weeks

    Subjective assessment of physical ability (DASI questionnaire)

Sponsors and collaborators

Lead sponsor

University of Nottingham

Other

Registry information

Official study title

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

Acronym: eHIT

Important dates

Study start
2015
Primary completion
2017
Study completion
2018
First posted
May 3, 2017
Registry last updated
Sep 13, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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