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

• Sponsor: University of Nottingham (Other)
• Overall Status: Completed
• CT.gov ID: NCT03473990
• Collaborator: (none)
• Enrollment: 48
• Location: 1
• Arms: 3
• Actual Duration (Months): 23.9
• Patients Per Site Per Month: 2

Study Details

Study Description

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 and older adults.

Condition or Disease	Intervention/Treatment	Phase
High-Intensity Interval Training	Other: High-intensity interval training	N/A

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

• Study Type: Interventional
• Actual Enrollment: 48 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: Oct 3, 2017
• Actual Primary Completion Date: Oct 1, 2019
• Actual Study Completion Date: Oct 1, 2019

Arms and Interventions

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 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
No Intervention: Control Group No intervention

Outcome Measures

Primary Outcome Measures

1. Change in VO2 Max (L/min) assessed by Cardio-pulmonary exercise test (CPET) [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 [31 days]

   To determine the efficacy of bodyweight HIT for improving aerobic fitness

2. Change in resting glucose and insulin sensitivity (mmol/L) [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 [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) [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 [31 days]

   To assess the feasibility and acceptability of performing a HIT programme at home

Eligibility Criteria

Criteria

• Ages Eligible for Study: 55 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The University of Nottingham, Division of Medical Sciences and Graduate Entry Medicine, School of Medicine, Royal Derby Hospital	Derby		United Kingdom	DE22 3DT

Sponsors and Collaborators

• 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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Bethan Phillips, Assistant Professor, University of Nottingham
• ClinicalTrials.gov Identifier: NCT03473990
• Other Study ID Numbers: C16122016
• First Posted: Mar 22, 2018
• Last Update Posted: Aug 17, 2020
• Last Verified: Aug 1, 2020

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Bethan Phillips, Assistant Professor, University of Nottingham: Home-based; Short-term; Randomised Control Trial

Study Results

No Results Posted as of Aug 17, 2020