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

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ClinicalTrials.gov Identifier: NCT03473990
Recruitment Status : Recruiting
First Posted : March 22, 2018
Last Update Posted : March 22, 2018
Sponsor:
Information provided by (Responsible Party):
Bethan Phillips, University of Nottingham

Brief 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.

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


Condition or disease Intervention/treatment Phase
High-Intensity Interval Training Other: High-intensity interval training Not Applicable

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.

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).


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
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
Actual Study Start Date : October 3, 2017
Estimated Primary Completion Date : February 1, 2019
Estimated Study Completion Date : August 1, 2019

Arm Intervention/treatment
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 Name: 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 Name: HIT

No Intervention: Control Group
No intervention



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Change in Anaerobic Threshold (L/min) using CPET [ Time Frame: 31 days ]
    To determine the efficacy of bodyweight HIT for improving aerobic fitness

  2. 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)

  3. Change in muscle architecture as assessed by ultrasound [ Time Frame: 31 days ]
    To assess the effects of HIT on improving muscle structure and function

  4. 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

  5. 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



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Ages Eligible for Study:   55 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03473990


Contacts
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Contact: Tanvir S Sian, BMBS, MRCS 01332 724640 tanvirsian@gmail.com

Locations
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United Kingdom
The University of Nottingham, Division of Medical Sciences and Graduate Entry Medicine, School of Medicine, Royal Derby Hospital Recruiting
Derby, United Kingdom, DE22 3DT
Contact: Bethan Philips, Assist. Prof    01332 724676    beth.phillips@nottingham.ac.uk   
Sponsors and Collaborators
University of Nottingham
Investigators
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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

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Responsible Party: Bethan Phillips, Assistant Professor, University of Nottingham
ClinicalTrials.gov Identifier: NCT03473990     History of Changes
Other Study ID Numbers: C16122016
First Posted: March 22, 2018    Key Record Dates
Last Update Posted: March 22, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Non-identifiable participant data will be made available for all outcome measures
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Time Frame: Duration of PhD (3 years)
Access Criteria: Password protected database only given to researchers with special access to the database

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Bethan Phillips, University of Nottingham:
Home-based
Short-term
Randomised Control Trial