Short-term, Home-based, High-intensity Interval Training (HIT) for Improving Fitness (HomeHIT)

August 12, 2020 updated by: Bethan Phillips, University of Nottingham

A Randomised Control Trial to Assess the Efficacy of Short-term, Home-based High- Intensity Interval Training (HIT) for Improving Indices of Cardiorespiratory Fitness

This study will aim to evaluate the efficacy of a short-term, home-based, high-intensity interval (HIT) programme in improving cardiovascular fitness in healthy volunteers aged 55 and above, with an age-comparison to younger individuals taking part in the same training regime.

It will also explore the efficacy of time-matched 'static' interventions for improving cardiovascular parameters in middle-aged females and older adults.

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.

Detailed Description

Patients with lower peak oxygen uptake have higher mortality and morbidity when undergoing major surgery. Aerobic fitness is a potentially modifiable risk factor for postoperative complications.

Traditional pre-operative exercise interventions to improve fitness involve high time and supervision-demands, often resulting in poor compliance. High-intensity interval training (HIT) is a time-efficient, feasible method to improve pre-operative fitness, however current studies only involve exercise in the laboratory setting.

Study Design Thirty-six healthy volunteers aged 55y and over will be randomly allocated to one of three groups: 1) Laboratory-HIT; 2) Home-HIT; 3) No intervention. All HIT sessions will involve a brief warm-up, followed by five 1-minute bouts of high-intensity (body-weight based) exercise, interspersed with 90-seconds recovery, concluding with a brief cool-down. The primary endpoint of the study is change in VO2 peak with secondary endpoints of changes in: anaerobic threshold, insulin sensitivity and muscle mass.

Subjects will be expected to perform up to a maximum of 16 HIT sessions (maximum 5 sessions per week) within a period of 31 days. Aerobic fitness will be assessed prior to and following the exercise, as will body composition, muscle structure, physical function and insulin sensitivity.

For the age comparison, 24 young individuals will be recruited to either a control or home-HIT arm.

In addition, the efficacy of time-matched 'static' interventions for improving cardiovascular parameters in 24 middle-aged females will also be assessed as exploratory work for these interventions.

The efficacy of the static interventions in older adults at home will also be explored.

Power calculation: The investigators performed a power calculation for the primary outcome of VO2 max in older adults using data from a previous study at our centre on home versus laboratory HIIT. Assuming an effect size F of 0.6 for three groups and a within group SD of 5, the alpha level was set at 0.05 and the 1-beta at 0.80. This concluded that 30 participants would be required. To allow for potential non-completion and missing data 36 older participants will be enrolled to the study (12 to each group).

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.
48

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
      • Derby, United Kingdom, DE22 3DT
        • The University of Nottingham, Division of Medical Sciences and Graduate Entry Medicine, School of 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

55 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

Age > 55 years Able to give informed consent

Exclusion Criteria:

  • Current participation in a formal exercise regime
  • A BMI < 18 or > 35 kg·m2

  • Active cardiovascular disease:

    • Uncontrolled hypertension (BP > 160/100)
    • Angina
    • Heart failure (class III/IV)
    • Significant arrhythmia
    • Right to left cardiac shunt
    • Recent cardiac event
  • Taking beta-adrenergic blocking agents

  • Cerebrovascular disease:

    • Previous stroke
    • Aneurysm (large vessel or intracranial)
    • Epilepsy

  • Respiratory disease including:

    • Pulmonary hypertension
    • Significant COPD
    • Uncontrolled asthma
  • Malignancy
  • Metabolic disease e.g. diabetic patients
  • Clotting dysfunction
  • Significant Musculoskeletal or neurological disorders
  • Family history of early (<55y) death from cardiovascular disease

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: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: None (Open Label)

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.
No Intervention: Control Group
No intervention
Active Comparator: Laboratory HIT
Supervised (Laboratory HIT) exercise in the lab up to 4 times per week for 4 weeks
Other: High-intensity interval training
2 minute warm up, followed by 5x1min HIT intervals separated by 90 seconds active recovery (walking on the spot) and then a 2 minute recovery period. The high intensity bouts will be a pyramid of exercises (star jumps, mountain climbers and on-the-spot sprints)
Other Names:
  • HIT
Active Comparator: Home HIT
Unsupervised (Home HIT) exercise at home up to 4 times per week for 4 weeks
Other: High-intensity interval training
2 minute warm up, followed by 5x1min HIT intervals separated by 90 seconds active recovery (walking on the spot) and then a 2 minute recovery period. The high intensity bouts will be a pyramid of exercises (star jumps, mountain climbers and on-the-spot sprints)
Other Names:
  • HIT

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
Change in VO2 Max (L/min) assessed by Cardio-pulmonary exercise test (CPET)
Time Frame: 31 days
To determine the efficacy of bodyweight HIT for improving aerobic fitness
31 days

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
Change in Anaerobic Threshold (L/min) using CPET
Time Frame: 31 days
To determine the efficacy of bodyweight HIT for improving aerobic fitness
31 days
Change in resting glucose and insulin sensitivity (mmol/L)
Time Frame: 31 days
The effects of HIT on improving glucose control using Oral Glucose Tolerance Test (OGTT) and enzyme-linked immunosorbent assay (ELISA)
31 days
Change in muscle architecture as assessed by ultrasound
Time Frame: 31 days
To assess the effects of HIT on improving muscle structure and function
31 days
Change in body composition (fat, muscle, bone (g)) as assessed by Dual-energy Xray Absorptiometry (DEXA)
Time Frame: 31 days
To assess the effects of HIT on improving muscle structure and function
31 days
Feasibility of home HIT assessed using a preset feasibility questionnaire
Time Frame: 31 days
To assess the feasibility and acceptability of performing a HIT programme at home
31 days

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: Bethan Philips, The University of Nottingham, Division of Medical Sciences and Graduate Entry Medicine, School of Medicine, Royal Derby Hospital, Derby, DE22 3DT

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Actual)

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.
October 3, 2017

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, 2019

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.
October 1, 2019

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).
October 31, 2017

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.
March 14, 2018

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.
March 22, 2018

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.
August 17, 2020

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.
August 12, 2020

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.
August 1, 2020

More Information

Terms related to this study

Keywords

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.
  • C16122016

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Non-identifiable participant data will be made available for all outcome measures

IPD Sharing Time Frame

Duration of PhD (3 years)

IPD Sharing Access Criteria

Password protected database only given to researchers with special access to the database

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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