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

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: Completed
• Conditions: High-Intensity Interval Training
• Intervention / Treatment: Other: High-intensity interval training

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: Interventional
• Enrollment (Actual): 48
• Phase: Not Applicable

Contacts and Locations

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

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Anaerobic Threshold (L/min) using CPET	To determine the efficacy of bodyweight HIT for improving aerobic fitness	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)	31 days
Change in muscle architecture as assessed by ultrasound	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)	To assess the effects of HIT on improving muscle structure and function	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	31 days

Collaborators and Investigators

• Sponsor: University of Nottingham
• Investigators: 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

General 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. Erratum In: BMC Geriatr. 2022 Dec 1;22(1):926.

Study record dates

Study Major Dates

• Study Start (Actual): October 3, 2017
• Primary Completion (Actual): October 1, 2019
• Study Completion (Actual): October 1, 2019

Study Registration Dates

• First Submitted: October 31, 2017
• First Submitted That Met QC Criteria: March 14, 2018
• First Posted (Actual): March 22, 2018

Study Record Updates

• Last Update Posted (Actual): August 17, 2020
• Last Update Submitted That Met QC Criteria: August 12, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Keywords: Randomised Control Trial; Home-based; Short-term
• Other Study ID 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