NCT04553614

Brief Summary

The prevalence of chronic inactivity related diseases including obesity, insulin resistance and type 2 diabetes mellitus has reached global epidemic proportions. Exercise training is a clinically proven primary intervention that delays and in many cases prevents health burdens. Therefore, many health authorities and local councils run exercise referral schemes for individuals with elevated disease disk. However, a number of barriers to successful completion of traditional exercise referral schemes exist. This study aims to investigate the use of a home-based high intensity interval training programme as a potential exercise referral scheme activity to overcome many of the barriers to successful exercise referral scheme adherence and uptake. 200 people referred to the Active Sefton (Sefton Council) exercise referral scheme will be recruited and randomised to one of the two exercise groups (existing Active Sefton Scheme gym based training or home-based HIT). All participants will have access to the normal Active Sefton support mechanisms, but the training programme followed will be different. Before and after 12 weeks of training volunteers will participate in testing to assess changes in aerobic fitness, physical activity, vascular function, insulin sensitivity, body composition and psychological well-being. A 3 month follow up will also be completed to investigate the long term consequences on these variables.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
154

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 10, 2017

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 19, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 19, 2019

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

September 4, 2020

Completed
13 days until next milestone

First Posted

Study publicly available on registry

September 17, 2020

Completed
Last Updated

September 17, 2020

Status Verified

September 1, 2020

Enrollment Period

1.9 years

First QC Date

September 4, 2020

Last Update Submit

September 11, 2020

Conditions

Risk Factor, Cardiovascular

Keywords

HIITCardiorespiratory fitnessHeart RateFeasibilityExerciseExercise PrescriptionPrimary Health CareHumans

Outcome Measures

Primary Outcomes (1)

  • Cardiorespiratory fitness

    Incremental exercise test to exhaustion to assess VO2peak

    3 months

Secondary Outcomes (3)

  • Body composition

    3 months

  • Insulin Sensitivity

    3 months

  • Exercise Adherence

    3 months

Study Arms (2)

Exercise Referral Scheme

ACTIVE COMPARATOR

The active Sefton (AS\_ERS) is a traditional exercise referral programme providing highly discounted access to council operated leisure centres and a number of partner gyms. Within this access patients will have access to gym and swimming facilities (£2 per visit) and exercises classes (£3 per visit). During the patients first meeting with their LDO a progressive personalised exercise programme will be developed. Following this the patient will attend their local gym or leisure centre for an induction with a staff member(£7 one off fee), enabling them to attend the centre at any time and complete the designed exercise programme. All exercise programmes will be different, but in general will include moderate intensity exercise on gym equipment (treadmill, ergometer etc.) and some basic resistance training. Patients may replace these gym sessions with exercises classes run by the facility. Patients will be encouraged to exercise 3-5 time per week.

Other: Control

Home-based HIIT

EXPERIMENTAL

Participants will be instructed to complete each training session in a place of their choosing. The programme involves repeated 1 minute bouts of simple on the spot movements interspersed with 1 minute of rest. During the intervals participants will be advised to reach a heart rate of approx. 90% of their predicted maximum heart rate (220-age). The 1 minute interval will be split between 2 consecutive 30 second exercises. The research team have a library of 18 exercises, with 9 suggested exercise pairs. The participant will be advised to complete 4 intervals during weeks 1 and 2, with the number of intervals increasing by 1 every 2 weeks (maximum of 9 intervals). The participant will be advised to train 3x per week.

Behavioral: Home-based HIIT

Interventions

Home-based HIITBEHAVIORAL

Home-based HIIT uses body-weight equipment free exercises. Participants complete all exercise in their own own at a time of their choosing. This potentially removes many of the barriers preventing at risk-individuals from engaging with the current exercise referral scheme, such as cost, time or intimidating gym environment.

Home-based HIIT
ControlOTHER

Usual exercise referral scheme procedure.

Exercise Referral Scheme

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Referred to Active Sefton Exercise Referral scheme by a GP Aged 18-65
  • Referral criteria:
  • High blood pressure Angina (treated and stable) Mental Health issues (anxiety/ stress/ depression) Previous Heart attack or heart surgery (not under current investigation) Diabetes type 1 or 2 Impaired glucose tolerance Overweight/ obese (BMI \>30)

You may not qualify if:

  • Aged \<18 or \>65
  • Cardiac rehab patient
  • In order to take part participants should have a good grasp of spoken English
  • Blood pressure \>180/100 and/or uncontrolled or poorly controlled hypertension
  • Currently prescribed Beta-blockers
  • Cardiomyopathy
  • Uncontrolled tachycardia
  • Cardiac arrhythmia
  • Valvular heart disease
  • Aneurysms
  • Diabetes and 1 of the following:
  • Aged \>35
  • Type 2 diabetes mellitus \>10 yr duration
  • Type 1 diabetes mellitus \>15 yr duration
  • Hypercholesterolemia (total cholesterol \>6.2 mmol/l)
  • +14 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Liverpool John Moores University

Liverpool, L33AF, United Kingdom

Location

Related Publications (1)

  • Hesketh K, Jones H, Kinnafick F, Shepherd SO, Wagenmakers AJM, Strauss JA, Cocks M. Home-Based HIIT and Traditional MICT Prescriptions Improve Cardiorespiratory Fitness to a Similar Extent Within an Exercise Referral Scheme for At-Risk Individuals. Front Physiol. 2021 Nov 10;12:750283. doi: 10.3389/fphys.2021.750283. eCollection 2021.

    PMID: 34858205DERIVED

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 4, 2020

First Posted

September 17, 2020

Study Start

October 10, 2017

Primary Completion

September 19, 2019

Study Completion

September 19, 2019

Last Updated

September 17, 2020

Record last verified: 2020-09

Locations

GB(1)