Feasibility of REHIT in NDH Patients

NCT04011397 | Completed

• 1 other identifier: UHuddersfield
• Study Type: interventional
• Target: 6
• Locations: 0 countries
• Sites: N/A

Brief Summary

The aim of this feasibility study was to describe and report data relevant to the acceptability of an exercise intervention (reduced-exertion, high-intensity interval training) in non-diabetic hyperglycaemia patients delivered in a National Health Service setting.

Conditions

Diabetes; Physical Activity

Keywords

Diabetes; Exercise; Feasibility; HbA1c; Interval training

Outcome Measures

Primary Outcomes (6)

• Number of patients screened and considered eligible to take part in the study

  Defined as the number of patients who had contact with the recruitment team and who were assessed for eligibility using inclusion and exclusion criteria.

  4-weeks

• Reporting of adverse events

  An adverse event was defined as any untoward occurrence that happened during the conduct of the study.

  From first exposure to intervention to last (approx. 6-weeks)

• Intervention adherence

  Intervention adherence was calculated by summing the total number of participants and the target number of REHIT sessions (15 per participant) and comparing this against the actual completed sessions.

  From first exposure to intervention to last (approx. 6-weeks)

• Change in affective valence (pleasure-displeasure)

  Pre-validated 'Feeling Scale' questionnaire which measure pleasure/displeasure responses during exercise. This is a single-item, 11-point, bipolar scale and ranges from - 5 'very bad' to + 5 'very good', with anchors designated for 0 (neutral) and all odd integers in-between. Lower scores are considered to be a worse outcome.

  Change from first exposure to intervention to last (approx. 6 weeks)

• Change in perceived exertion

  Pre-validated 'Rating of Perceived Exertion' questionnaire which measures perceived effort during exercise. This is a 15-point scale and ranges from 6 'no exertion' to 20 'maximal exertion' with anchors designated for all the odd integers in-between. A higher score is considered a worse outcome.

  Change from first exposure to intervention to last (approx. 6 weeks)

• Change in enjoyment

  Pre-validated 'Exercise Enjoyment Scale' (ESS) which measures enjoyment associated with exercise. This is a single-item, 7-point scale. Anchors are given at every integer, ranging from 1 'not at all' to 7 'extremely'. A lower score is a worse outcome.

  Change from first exposure to intervention to last (approx. 6 weeks)

Secondary Outcomes (4)

• Change in peak oxygen uptake (fitness test)

  Change from baseline peak oxygen uptake at approx. 6-weeks

• Change in HBA1c (blood test)

  Change from baseline HbA1c at approx. 6-weeks

• Change in body composition

  Change from baseline body composition at approx. 6-weeks

• Change in systolic and diastolic blood pressure

  Change from baseline systolic and diastolic blood pressure at approx. 6-weeks

Study Arms (1)

Intervention group

EXPERIMENTAL

Exercise intervention (reduced-exertion, high-intensity interval training) alongside normal treatment. \[low recruitment prohibited control arm\]

Other: Exercise intervention; Behavioral: Usual care

Interventions

Exercise intervention OTHER

Exercise intervention (reduced-exertion, high-intensity interval training) delivered within an NHS setting. Consisted 10 min of cycle ergometry (inclusive of warm-up and cool down) including very brief maximal cycle sprints.

Intervention group

Usual care BEHAVIORAL

Members of a multi-disciplinary team including a consultant, diabetes specialist nurse, clinical psychologist, physiotherapist, and dietician worked together to promote patient self-management. Care was tailored to the specific circumstances of each patient after initial assessment and focussed on weight management, dietary education, behavioural therapy, and supported pharmacotherapy initiation as appropriate.

Intervention group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Accessing the NHS Trust Weight Management Service (Specialist Diabesity Clinic)
• Aged between 18 and 65 years (inclusive)
• Diagnosed as NDH (using standard criteria)
• Male or female
• Any ethnicity
• Not currently partaking in a new structured exercise intervention
• Considered low or medium risk for exercise using standard risk stratification \[37\]

You may not qualify if:

• \< 18 years and ≥ 66 years
• Currently partaking in a new structured exercise intervention
• Euglycaemic
• Diagnosed with type 1 or type 2 diabetes; taking insulin; history of end stage liver or kidney disease, neuropathy or retinopathy; has hypertension that cannot be controlled by standard medication; has cardiovascular disease, or another contraindication to exercise
• Considered high risk for exercise using standard risk stratification \[37\]
• Unable to adequately understand verbal explanations and written information given in English (there were no funds available for translation services)

Sponsors & Collaborators

• University of Huddersfield: lead

Related Publications (1)

• Haines M. Feasibility of procedures for a randomised pilot study of reduced exertion, high-intensity interval training (REHIT) with non-diabetic hyperglycaemia patients. Pilot Feasibility Stud. 2020 Feb 19;6:28. doi: 10.1186/s40814-020-00571-8. eCollection 2020.

  PMID: 32099663 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus; Motor Activity

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Behavior

Study Officials

• Matthew Haines

  University of Huddersfield

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Feasibility study

Study Record Dates

• First Submitted: June 26, 2019
• First Posted: July 8, 2019
• Study Start: March 1, 2016
• Primary Completion: January 1, 2017
• Study Completion: January 1, 2017
• Last Updated: July 9, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share