High-Intensity Interval TrainingHomeHITNCT03473990
Short-term, Home-based, High-intensity Interval Training (HIT) for Improving Fitness
A study testing High-intensity interval training in people with High-Intensity Interval Training, run by University of Nottingham at 1 site in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 55 years and olderHealthy volunteers can take part
- Conditions the study is for
- High-Intensity Interval Training
- What is being tested?
- High-intensity interval training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 3 Oct 2017to 1 Oct 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age > 55 years Able to give informed consent
Who cannot join
- 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)
Show all 23Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
The University of Nottingham, Division of Medical Sciences and Graduate Entry Medicine, School of Medicine, Royal Derby Hospital
Derby, DE22 3DT
About this study
Official title: 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.
Read the 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).
- Conditions
- High-Intensity Interval Training
- Being tested
- High-intensity interval training
- Keywords
- Home-based, Short-term, Randomised Control Trial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-intensity interval trainingOther
Also called HIT
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)
| Study group | Role | What they receive |
|---|---|---|
| Laboratory HIT | Active comparator | Supervised (Laboratory HIT) exercise in the lab up to 4 times per week for 4 weeks Receives: Other: High-intensity interval training |
| Home HIT | Active comparator | Unsupervised (Home HIT) exercise at home up to 4 times per week for 4 weeks Receives: Other: High-intensity interval training |
| Control Group | No intervention | No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in VO2 Max (L/min) assessed by Cardio-pulmonary exercise test (CPET)
To determine the efficacy of bodyweight HIT for improving aerobic fitness
Measured: 31 days
Secondary outcomes (5)
Change in Anaerobic Threshold (L/min) using CPET
To determine the efficacy of bodyweight HIT for improving aerobic fitness
Measured: 31 days
Change in resting glucose and insulin sensitivity (mmol/L)
The effects of HIT on improving glucose control using Oral Glucose Tolerance Test (OGTT) and enzyme-linked immunosorbent assay (ELISA)
Measured: 31 days
Change in muscle architecture as assessed by ultrasound
To assess the effects of HIT on improving muscle structure and function
Measured: 31 days
Change in body composition (fat, muscle, bone (g)) as assessed by Dual-energy Xray Absorptiometry (DEXA)
To assess the effects of HIT on improving muscle structure and function
Measured: 31 days
Feasibility of home HIT assessed using a preset feasibility questionnaire
To assess the feasibility and acceptability of performing a HIT programme at home
Measured: 31 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2018
- Study start3 Oct 2017
- Primary completion1 Oct 2019
- Study completion1 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for High-Intensity Interval TrainingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nottingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bethan Phillips, University of Nottingham
- Investigators
- Bethan Philips, Principal investigator, The University of Nottingham, Division of Medical Sciences and Graduate Entry Medicine, School of Medicine, Royal Derby Hospital, Derby, DE22 3DT
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03473990
- Sponsor's protocol ID
- C16122016
- Acronym
- HomeHIT
- Status last verified
- Aug 2020
- First submitted
- 31 Oct 2017
- Last updated
- 17 Aug 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Non-identifiable participant data will be made available for all outcome measures
Publications
Sian TS, Inns TB, Gates A, Doleman B, Bass JJ, Atherton PJ, Lund JN, Phillips BE. Equipment-free, unsupervised high intensity interval training elicits significant improvements in the physiological resilience of older adults. BMC Geriatr. 2022 Jun 28;22(1):529. doi: 10.1186/s12877-022-03208-y.
PubMed 35761262
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Control Trial to Assess the Efficacy of Short-term, Home-based High- Intensity Interval Training (HIT) for Improving Indices of Cardiorespiratory Fitness
- ClinicalTrials.gov ID
- NCT03473990
- Acronym / sponsor ID
- HomeHIT / C16122016
- Conditions
- High-Intensity Interval Training
- Keywords
- Home-based, Short-term, Randomised Control Trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- University of NottinghamUniversity, hospital or other
- Study start
- 3 Oct 2017 (actual)
- Primary completion
- 1 Oct 2019 (actual)
- Study completion
- 1 Oct 2019 (actual)
- First posted
- 22 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Laboratory HIT | Active comparator | Other: High-intensity interval trainingSupervised (Laboratory HIT) exercise in the lab up to 4 times per week for 4 weeks |
| Home HIT | Active comparator | Other: High-intensity interval trainingUnsupervised (Home HIT) exercise at home up to 4 times per week for 4 weeks |
| Control Group | No intervention | –No intervention |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Age > 55 years Able to give informed consent
Key exclusion criteria (23 listed)
- Current participation in a formal exercise regime
- A BMI < 18 or > 35 kg·m2
- Active cardiovascular disease:
- Taking beta-adrenergic blocking agents
- Cerebrovascular disease:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High-intensity interval trainingAlso: HIT2 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 | Home HIT, Laboratory HIT |
Primary outcome
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
5 secondary outcomes
Change in Anaerobic Threshold (L/min) using CPET
Time frame: 31 days
Change in resting glucose and insulin sensitivity (mmol/L)
Time frame: 31 days
Change in muscle architecture as assessed by ultrasound
Time frame: 31 days
Change in body composition (fat, muscle, bone (g)) as assessed by Dual-energy Xray Absorptiometry (DEXA)
Time frame: 31 days
Feasibility of home HIT assessed using a preset feasibility questionnaire
Time frame: 31 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2020.
- Derived from this study: PubMed 35761262Sian TS, Inns TB, Gates A, Doleman B, Bass JJ, Atherton PJ, Lund JN, Phillips BE. Equipment-free, unsupervised high intensity interval training elicits significant improvements in the physiological resilience of older adults. BMC Geriatr. 2022 Jun 28;22(1):529. doi: 10.1186/s12877-022-03208-y.
- Individual participant dataSharing planned: Yes. Non-identifiable participant data will be made available for all outcome measures
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bethan Philips principal investigator
The University of Nottingham, Division of Medical Sciences and Graduate Entry Medicine, School of Medicine, Royal Derby Hospital, Derby, DE22 3DT
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High-intensity interval training in people with High-Intensity Interval Training, run by University of Nottingham at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in VO2 Max (L/min) assessed by Cardio-pulmonary exercise test (CPET) (time frame: 31 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03473990, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2020; AzTrials last refreshed its copy on 29 Oct 2026.