NCT03138265

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2015

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

September 21, 2015

Completed
1.6 years until next milestone

First Posted

Study publicly available on registry

May 3, 2017

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2017

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2018

Completed
Last Updated

September 13, 2018

Status Verified

September 1, 2018

Enrollment Period

2.1 years

First QC Date

September 21, 2015

Last Update Submit

September 12, 2018

Conditions

SarcopeniaAgedExercisePreoperative Care

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (8)

  • Mean VO2 peak improvement following 4 week HIT protocol.

    4 weeks

  • Muscle protein synthesis

    4 weeks

  • Body composition

    4 weeks

  • Muscle architecture

    4 weeks

  • Feasibility

    4 Weeks

  • +3 more secondary outcomes

Study Arms (1)

High intensity exercise training

EXPERIMENTAL

HIT training protocol.

Behavioral: HIIT Device: ergometer

Interventions

HIIT Device: ergometerBEHAVIORAL

Supervised exercise training.

Also known as: High intensity interval training
High intensity exercise training

Eligibility Criteria

Age70 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.
  • 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.
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

School of Graduate Entry Medicine, Royal Derby Hospital

Derby, Derbyshire, DE22 3DT, United Kingdom

Location

MeSH Terms

Conditions

SarcopeniaMotor Activity

Interventions

High-Intensity Interval Training

Condition Hierarchy (Ancestors)

Muscular AtrophyNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsSigns and SymptomsBehavior

Intervention Hierarchy (Ancestors)

Physical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • John Williams, BSc MBChB FRCA PhD

    Nottingham University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
SINGLE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 21, 2015

First Posted

May 3, 2017

Study Start

September 1, 2015

Primary Completion

October 1, 2017

Study Completion

April 1, 2018

Last Updated

September 13, 2018

Record last verified: 2018-09

Locations

GB(1)