SarcopeniaeHITNCT03138265
HIT Training in the Frail Elderly.
A study testing HIIT Device: ergometer in people with Sarcopenia and Aged, run by University of Nottingham at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 70 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sarcopenia, Aged, Exercise
- What is being tested?
- HIIT Device: ergometer
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Sep 2015to Apr 2018
- 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 70 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
Show all 18Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
School of Graduate Entry Medicine, Royal Derby Hospital
Derby, Derbyshire, DE22 3DT
About this study
Official title: Improvements in Aerobic Performance Following a Four-week Period of High Intensity Interval Training in the 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.
- Conditions
- Sarcopenia, Aged, Exercise, Preoperative Care
- Being tested
- HIIT Device: ergometer
- Medical subject headings
- Sarcopenia, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HIIT Device: ergometerBehavioural
Also called High intensity interval training
Supervised exercise training.
| Study group | Role | What they receive |
|---|---|---|
| High intensity exercise training | Experimental | HIT training protocol. Receives: Behavioral: HIIT Device: ergometer |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 weeks
Secondary outcomes (8)
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.
Measured: 4 weeks
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).
Measured: 4 weeks
Body composition
DXA changes in body composition (lean muscle mass (%), fat mass (%) and bone density g/cm3)) following a HIT programme
Measured: 4 weeks
Muscle architecture
Ultrasound scans used to assess changes in lean muscle mass and architecture following a HIT programme (mm and % pennation angle change).
Measured: 4 weeks
Feasibility
Determination of frail elderly patient adherence to HIT programme (number of scheduled sessions successfully completed within 28 days).
Measured: 4 Weeks
Quality of life improvement
Quality of life questionnaires to measure subjective outcomes (EQ-5D questionnaire)
Measured: 4 weeks
Daily Activity Level
Activity questionnaire to quantify habitual physical activity (IPAQ questionnaire)
Measured: 4 weeks
Physical Activity Score
Subjective assessment of physical ability (DASI questionnaire)
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2017
- Study startSep 2015
- Primary completionOct 2017
- Study completionApr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SarcopeniaStudies 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nottingham
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- John Williams, BSc MBChB FRCA PhD, Principal investigator, Nottingham University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03138265
- Sponsor's protocol ID
- eHIT_Protocol
- Acronym
- eHIT
- Status last verified
- Sep 2018
- First submitted
- 21 Sep 2015
- Last updated
- 13 Sep 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improvements in Aerobic Performance Following a Four-week Period of High Intensity Interval Training in the Elderly.
- ClinicalTrials.gov ID
- NCT03138265
- Acronym / sponsor ID
- eHIT / eHIT_Protocol
- Conditions
- Sarcopenia, Aged, Exercise, Preoperative Care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- University of NottinghamUniversity, hospital or other
- Study start
- Sep 2015
- Primary completion
- Oct 2017 (actual)
- Study completion
- Apr 2018 (actual)
- First posted
- 3 May 2017 (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 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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| High intensity exercise training | Experimental | Behavioral: HIIT Device: ergometerHIT training protocol. |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (18 listed)
- Participants under the age of 70 years.
- Myocardial infarction (within last 6 months)
- Unstable Angina
- Heart failure (NYHA class III/IV)
- Uncontrolled Hypertension (BP>160/100)
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 |
|---|---|---|
| HIIT Device: ergometerAlso: High intensity interval trainingSupervised exercise training. | Behavioural | High intensity exercise training |
Primary outcome
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.
8 secondary outcomes
Mean VO2 peak improvement following 4 week HIT protocol.
Time frame: 4 weeks
Muscle protein synthesis
Time frame: 4 weeks
Body composition
Time frame: 4 weeks
Muscle architecture
Time frame: 4 weeks
Feasibility
Time frame: 4 Weeks
Quality of life improvement
Time frame: 4 weeks
Daily Activity Level
Time frame: 4 weeks
Physical Activity Score
Time frame: 4 weeks
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 13 Sep 2018.
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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.
John Williams, BSc MBChB FRCA PhD principal investigator
Nottingham University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HIIT Device: ergometer in people with Sarcopenia and Aged, 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 4 inclusion and 18 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 13 Sep 2018. 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?
Mean anaerobic threshold improvement following 4 week HIT protocol. (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Sep 2018.