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High Intensity Interval Training in Severe Mental Illness

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ClinicalTrials.gov Identifier: NCT03959735
Recruitment Status : Not yet recruiting
First Posted : May 22, 2019
Last Update Posted : June 24, 2019
Sponsor:
Collaborators:
National Institute for Health Research, United Kingdom
South London and Maudsley NHS Foundation Trust
Information provided by (Responsible Party):
King's College London

Brief Summary:

People experiencing severe mental illnesses (SMI), including schizophrenia, psychosis, bipolar disorder and major depressive disorder, are prone to poorer physical health and increased incidences of premature mortality when compared to the general population (De Hert et al., 2009; Hert et al., 2011; Hennekens et al., 2005; Tiihonen et al., 2009 . High-intensity-interval-training (HIIT) is a type of exercise involving alternating short bursts of high intensity exercise with recovery periods of rest/ light exercise (Weston, Wisløff & Coombes, 2014). HIIT improves physical health, quality of life and cognition in the general population and in those with physical health disorders (Gomes-Neto et al., 2017; Hwang, Wu & Chou, 2011; Wen et al., 2019). It has been proposed that HIIT may improve symptoms, physical health and time to discharge among inpatients with SMI.

The research will involve three stages: 1) Focus groups, 2) A pilot study, 3) Follow-up qualitative interviews and focus groups.

Firstly, a series of focus groups with inpatients with SMI, carers of individuals with SMI and clinical staff will be conducted. The focus groups will scope perceptions of attitudes, and practicalities of a pilot RCT. The information gained will be used to inform a pilot HIIT trial which will evaluate whether HIIT is acceptable and feasible amongst this population group. Each focus group will run for ≈2 hours and will involve an open discussion about the benefits and barriers of conducting HIIT exercise sessions in a population with SMI.

Secondly, the HIIT pilot study will be trialed. The final protocol will be developed with feedback from the focus group but will involve an RCT where 12 weeks of HIIT will be compared to 12 weeks of treatment-as-usual (TAU). HIIT will be conducted, twice a week, in a supervised environment using a stationary bike. Inpatients with a diagnosis of SMI will be eligible to participate. Thirdly, follow-up qualitative interviews, with pilot study participants, those that withdrew and those that did not want to take part, and focus groups with clinical staff will address the acceptability and feasibility of HIIT.


Condition or disease Intervention/treatment Phase
Major Depressive Disorder Bipolar Disorder Schizophrenia Other: High Intensity Interval Training (HIIT) Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Feasibility Randomized Controlled Trial (RCT)
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: "Is the Use of High Intensity Interval Training (HIIT) Feasible and Acceptable Amongst Inpatients With Severe Mental Illness (SMI)?" A Pilot Study
Estimated Study Start Date : August 2019
Estimated Primary Completion Date : March 2021
Estimated Study Completion Date : April 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Mental Disorders

Arm Intervention/treatment
Experimental: High Intensity Interval Training (HIIT)

50% of participants (inpatients with a diagnosis of severe mental illness) will be randomised to HIIT. HIIT will be conducted twice a week for 12 weeks using a stationary bike. Each session will have the following structure: 4-minute warm-up, followed by 5X1 minute intervals at 85-95% of maximum heart rate, interspersed with active pauses of 90 seconds cycling at approximately 60-70% of maximum heart rate, and a 4-minute cool-down. Each exercise session will take 19 minutes to complete (11 minutes of HIIT + warm-up and cool-down). However, the amount of HIIT will be adapted for people who may be unable to complete the above target and gradually build up until they can complete the recommended amount.

All exercise sessions will be conducted in a 1:1 environment with a participant and a member of the research team who will supervise the exercise session.

Other: High Intensity Interval Training (HIIT)
HIIT is a type of exercise involving alternating short bursts of high intensity exercise with recovery periods of rest or light exercise.

No Intervention: Treatment As Usual (TAU)
50% of participants will be randomised to TAU. They will be provided with details of the local hospital gym availability and instructed to maintain their usual dietary habits



Primary Outcome Measures :
  1. Number of wards that agree to hosting the HIIT Pilot Study and number that do not agree to hosting the HIIT pilot study [ Time Frame: Through study completion, an average of 1 year ]
    as assessed via a tally of acceptances and refusals

  2. Number of people who consent to take part [ Time Frame: Through study completion, an average of 1 year ]
    as assessed via a tally of acceptances and refusals

  3. Average adherence to HIIT sessions and assessments [ Time Frame: Throughout length of participation in the HIIT trial, 12 weeks ]
    as assessed via a record of number of HIIT sessions and number of assessments attended, and number of HIIT sessions and assessments not attended

  4. Number of Participants With Treatment-Related Adverse Events [ Time Frame: Through study completion, an average of 1 year ]
    as assessed via a tally of all medical effects observed and all medical effects reported by participants


Secondary Outcome Measures :
  1. BMI [ Time Frame: baseline, 6-weeks, 12-weeks ]
    BMI will be measured according to criteria set out by the International Diabetes Federation (IDF). A BMI between 18.5 to 24.9 will be interpreted as a healthy weight. Scores between 25 and 29.9 will be interpreted as overweight and a BMI >30kg/m² will be classified as central obesity.

  2. Weight [ Time Frame: baseline, 6-weeks, 12-weeks ]
    Weight will be measured in Kg using household scales. The investigators will assess whether weight decreases after participation in the HIIT trial.

  3. Waist Circumference (WC) [ Time Frame: baseline, 6-weeks, 12-weeks ]
    WC will be measured according to criteria set out by the International Diabetes Febderation (IDF). For Europids, a WC ≥ 94 cm and ≥ 80 cm indicates central obesity for men and women respectively. For persons from South Asia, China and Japan the cut-offs are ≥ 90 cm and ≥ 80 cm for men and women respectively.

  4. Systolic and diastolic blood pressure [ Time Frame: baseline, 6-weeks, 12-weeks ]
    Blood pressure will be measured using a blood pressure monitor. Higher systolic and diastolic blood pressure indicates lower cardiovascular function.

  5. Maximal oxygen uptake (VO2max) [ Time Frame: baseline, 6-weeks, 12-weeks ]
    VO2max will be measured using the YMCA cycle ergometer test which is a graded exercise test. Higher VO2max scores indicate greater cardiorespiratory fitness.

  6. Gait speed [ Time Frame: baseline, 6-weeks, 12-weeks ]
    The investigators will measure time taken to walk 6 meters. Longer times indicate reduced physical fitness.

  7. Change in Montreal Cognitive Assessment (MoCA) score [ Time Frame: baseline, 6-weeks, 12-weeks ]
    MoCA scores range between 0 and 30. Lower scores indicate worse cognitive functioning. A score of 26 or over is considered to be normal.

  8. Change in global assessment of functioning scale (GAF) score [ Time Frame: baseline, 6-weeks, 12-weeks ]
    GAF scores range from 0-100. Lower scores indicate worse global functioning. A score under 50 indicates severe impairment to functioning.

  9. Change in Brief Psychiatric Rating Scale (BPRS) score [ Time Frame: baseline, 6-weeks, 12-weeks ]
    The BPRS measures depression, anxiety, hallucinations and unusual behaviour. 24 items are rated from 1-7. A higher score indicates more severe psychiatric symptoms.

  10. Change in the brief insomnia severity index (ISI) [ Time Frame: baseline, 6-weeks, 12-weeks ]
    ISI scores range from 0-28. 0-7 indicates no clinically significant insomnia, 8-14 indicates sub-threshold insomnia and 15-28 indicates clinical insomnia.

  11. Cigarette intake [ Time Frame: baseline, 6-weeks, 12-weeks ]
    Participants will be asked how many cigarettes they smoke on a typical day.

  12. Change in Depression Anxiety Stress Scale short version (DASS21) score [ Time Frame: baseline, before and after the first HIIT session (or before and after 19 minutes of rest for the TAU arm), 6-weeks, 12-weeks ]
    The DASS21 contains 7 items for depression, 7 for anxiety and 7 for stress. Each subscale is scored from 0-42. Higher scores indicate higher levels of depression, anxiety and stress. Scores of 21, 15 and 26 indicate severe depression, anxiety and stress respectively.

  13. Change in Penn State Worry Questionnaire (PSWQ) score [ Time Frame: baseline, before and after the first HIIT session (or before and after 19 minutes of rest for the TAU arm), 6-weeks, 12-weeks ]
    Scores range from 16-80. Higher scores indicate more worry. 40-59 indicates moderate worry and 60+ indicates high worry.

  14. Change in the Rosenberg Self-Esteem Scale (RSES) score [ Time Frame: baseline, 6-weeks, 12-weeks ]
    RSES scores range from 0-30. Lower scores indicate lower self-esteem. A score under 15 may indicate problematic low self-esteem.

  15. Change in the International Physical Activity Questionnaire (IPAQ) score [ Time Frame: baseline, 6-weeks, 12-weeks ]
    Participants are asked to quantify how much physical activity they have completed over the past 7 days.

  16. Change in the Behavioural Regulation in Exercise Questionnaire-3 (BREQ-3) score [ Time Frame: baseline, 6-weeks, 12-weeks ]
    The BREQ contains 24 items with a score ranging from 0-4 for each item. The items are grouped into 6 factors with 4 items in each factor. Scores from each factor are combined using a weighting approach. Higher, positive scores indicate greater relative autonomy; lower, negative scores indicate more controlled regulation.


Other Outcome Measures:
  1. Appetite cravings [ Time Frame: before and after the first HIIT session (or before and after 19 minutes of rest for the TAU arm ]
    Participants will be asked: 'On a scale of 0-10 how much do you feel like smoking?' (0 will indicate no craving and 10 will indicate a craving)

  2. Cigarette cravings [ Time Frame: before and after the first HIIT session (or before and after 19 minutes of rest for the TAU arm ]
    Participants will be asked: 'On a scale of 0-10 how much do you feel like eating a snack right now? And if you do feel like eating what would it be?' (0 will indicate no craving and 10 will indicate a craving)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Stage 1 (Focus Groups):

  • Capacity to provide informed consent.
  • Aged ≥18 years.
  • Either be: 1) Inpatients at SLaM with a diagnosis of SMI (Major Depressive Disorder, Bipolar disorder, Schizophrenia Spectrum Disorders, 2) Carers providing unpaid support to someone with a SMI, 3) Clinical staff at SLaM.

Stage 2 (HIIT Pilot RCT):

  • Inpatients at SLaM with a diagnosis of SMI.
  • Capacity to provide informed consent.
  • Aged 18 -60.
  • Ready to exercise according to the Physical Activity Readiness Questionnaire.

Stage 3 (Follow-up): Qualitative interview:

  • inpatients who were eligible for stage 2.

Stage 3 (Follow-up): Focus group:

  • staff who participated in stage 1.

Exclusion Criteria:

Stage 1 (Focus Groups):

  • Is aged <18 years old.

Stage 2 (HIIT Pilot RCT) & Stage 3 qualitative interviews:

  • Is aged <18 years old or >60 years old.
  • Is pregnant.
  • Has an eating disorder.
  • Has a medical condition that impedes exercise, (as assessed via discussion with the patient's clinical team).

Stage 3 focus group:

  • Did not complete stage one.

ALL STAGES:

  • Is unable to provide informed consent.
  • Is unable to understand English.

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): NCT03959735


Contacts
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Contact: Rebecca N Martland, MSc 07551988500 rebecca.martland@kcl.ac.uk
Contact: Brendon Stubbs, PhD 00442032283877 brendon.stubbs@kcl.ac.uk

Sponsors and Collaborators
King's College London
National Institute for Health Research, United Kingdom
South London and Maudsley NHS Foundation Trust
Investigators
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Principal Investigator: Brendon Stubbs King's College London

Publications:

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Responsible Party: King's College London
ClinicalTrials.gov Identifier: NCT03959735     History of Changes
Other Study ID Numbers: IRAS263996
First Posted: May 22, 2019    Key Record Dates
Last Update Posted: June 24, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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 King's College London:
inpatients
Additional relevant MeSH terms:
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Disease
Schizophrenia
Depressive Disorder
Depressive Disorder, Major
Bipolar Disorder
Pathologic Processes
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Mood Disorders
Bipolar and Related Disorders