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The Umeå High-Intensity Training Study (Umeå HIT)

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ClinicalTrials.gov Identifier: NCT03765385
Recruitment Status : Recruiting
First Posted : December 5, 2018
Last Update Posted : January 11, 2019
Sponsor:
Information provided by (Responsible Party):
Umeå University

Tracking Information
First Submitted Date  ICMJE November 26, 2018
First Posted Date  ICMJE December 5, 2018
Last Update Posted Date January 11, 2019
Actual Study Start Date  ICMJE December 13, 2018
Estimated Primary Completion Date June 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 3, 2018)
  • Change from baseline cardiovascular capacity at 3 months and at 9 months, respectively. [ Time Frame: Baseline, 3 months, 9 months ]
    Maximum oxygen uptake (VO2 max)
  • Change from baseline cognitive function at 3 months and at 9 months, respectively. [ Time Frame: Baseline, 3 months, 9 months ]
    Measured using standardized tests covering: episodic memory (free recall, paired associates), executive functions (n-back, Trail Making Test (TMT) 4, flanker task), visuospatial ability (spatial relations), working memory (digit span) and processing speed (Trail Making Test (TMT) 2 and 3). The cognitive tasks are first z-transformed and then everaged to form a unit-weighted cognitive score as well as domain specific constructs.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03765385 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 3, 2018)
  • Change from baseline brain function at 3 months. [ Time Frame: Baseline, 3 months ]
    Assessed using functional MRI (fMRI) using two paradigms. Test A will estimate functional brain response during working memory manipulation and maintenance. Test B will estimate brain response during a pattern completion/separation paradigm. Separate analyses will be performed for fMRI paradigm A and B respectively. For each paradigm changes of % signal BOLD change will be analysed.
  • Change from baseline brain structure at 3 months. [ Time Frame: Baseline, 3 months ]
    Assessed using standard MRI-sequences including T1w, T2w, T2-FLAIR. For structural MRI data volume (mm3) and cortical thickness (mm) will be the unit of measure.
  • Change from baseline strength in knee extensors at 3 months and at 9 months, respectively. [ Time Frame: Baseline, 3 months, 9 months ]
    Maximal isometric strength in knee extensor measured as normalized joint torque in newton meters per kilogram bodyweight (Nm/kg).
  • Change from baseline hand grip strength at 3 months and at 9 months, respectively. [ Time Frame: Baseline, 3 months, 9 months ]
    Maximal hand grip strength measured as normalized force in Newtons per kilogram bodyweight (N/kg).
  • Change from baseline leg extensor muscle power at 3 months and at 9 months, respectively. [ Time Frame: Baseline, 3 months, 9 months ]
    Leg extensor power in the Nottingham Power Rig, measured as peak power output (watt).
  • Change from baseline functional performance at 3 months and at 9 months, respectively. [ Time Frame: Baseline, 3 months, 9 months ]
    Chair-stand test, number of chair-stands during 30 seconds.
  • Change from baseline functional balance at 3 months and at 9 months, respectively. [ Time Frame: Baseline, 3 months, 9 months ]
    One-leg stance: number of seconds able to stand on one leg (maximum 120 seconds).
  • Change from baseline functional balance at 3 months and at 9 months, respectively. [ Time Frame: Baseline, 3 months, 9 months ]
    Step test, number of steps during 30 seconds.
  • Change from baseline anxiety and depression at 3 months and at 9 months, respectively. [ Time Frame: Baseline, 3 months, 9 months ]
    Hospital anxiety and depression scale (HAD): range 0-42, higher score indicates more symptoms.
  • Change from baseline health related quality of life at 3 months and at 9 months, respectively. [ Time Frame: Baseline, 3 months, 9 months ]
    Short Form Health Survey (SF-36): scores transformed to 0 to 100, higher scores indicates better quality of life.
  • Change from baseline self-efficacy at 3 months and at 9 months, respectively. [ Time Frame: Baseline, 3 months, 9 months ]
    Swedish Exercise Self Efficacy Scale (ESES-S): Range 10-40, higher score indicates more self efficacy.
  • Change from baseline sleep quality at 3 months and at 9 months, respectively. [ Time Frame: Baseline, 3 months, 9 months ]
    One question (no. 3) regarding sleep from Montgomery-Åsberg Depression Rating Scale (MADRS).
  • Change from baseline objective physical activity at 1.5 months (mid-training), at 3 months and at 9 months, respectively. [ Time Frame: Baseline, 1.5 months, 3 months, 9 months ]
    Physical activity measured by an activity monitor, the Actigraph. Number of steps per day and number of activity counts per day will be measured.
  • Change from baseline self-reported physical activity at 1.5 months (mid-training), at 3 months and at 9 months, respectively. [ Time Frame: Baseline, 1.5 months, 3 months, 9 months ]
    Two indicator questions on physical activity from the Swedish National Board of Health and Welfare.
  • Change from baseline metabolic health at 3 months and at 9 months, respectively. [ Time Frame: Baseline, 3 months, 9 months ]
    Oral glucose tolerance test (OGTT):blood glucose in mmol/l,
  • Change from baseline lipid profile at 3 months and at 9 months, respectively. [ Time Frame: Baseline, 3 months, 9 months ]
    Lipid profile, measured by total cholesterol as well as separately as LDL- cholesterol and HDL-cholesterol. Unit of measure is mmol/l.
  • Change from baseline inflammation markers at 3 months and at 9 months, respectively. [ Time Frame: Baseline, 3 months, 9 months ]
    C-reactive protein (CRP) in blood sample, units of measure is mg/l.
  • Change from baseline inflammation markers at 3 months and at 9 months, respectively. [ Time Frame: Baseline, 3 months, 9 months ]
    Interleukins in blood sample, units of measure is pg/ml.
  • Change from baseline neurotrophic factors at 3 months and at 9 months, respectively. [ Time Frame: Baseline, 3 months, 9 months ]
    Insulin-like growth factor 1 (IGF-1), units of measure is pg/ml.
  • Change from baseline neurotrophic factors at 3 months and at 9 months, respectively. [ Time Frame: Baseline, 3 months, 9 months ]
    Brain-derived neurotrophic factor (BDNF), units of measure is pg/ml.
  • Change from baseline blood pressure at 1.5 months (mid-training), at 3 months and at 9 months, respectively. [ Time Frame: Baseline, 1.5 months, 3 months, 9 months ]
    Blood pressure at rest, measured as systolic ans diastolic pressure in mmHg.
  • Change from baseline resting heart rate at 1.5 months (mid-training), at 3 months and at 9 months, respectively. [ Time Frame: Baseline, 1.5 months, 3 months, 9 months ]
    Resting heart rate, measured as beats per minute.
  • Change from baseline autonomic function at 1.5 months (mid-training), at 3 months and at 9 months, respectively. [ Time Frame: Baseline, 1.5 months, 3 months, 9 months ]
    Heart rate variability (HRV), measured in the time domain (e.g. RMSSD) and frequency domain (LF:HF).
  • Applicability of the interventions [ Time Frame: Through the whole 3-month intervention period ]
    Attendance: number of sessions attended.
  • Applicability of the interventions [ Time Frame: Through the whole 3-month intervention period ]
    Absolute work-load during training in Watt.
  • Applicability of the interventions [ Time Frame: Through the whole 3-month intervention period ]
    Relative training intensity, as percentage of MAP (Maximum Aerobic Power output).
  • Applicability of the interventions [ Time Frame: Through the whole 3-month intervention period ]
    Relative training intensity, as percentage of MHR (maximum heart rate).
  • Applicability of the interventions [ Time Frame: Through the whole 3-month intervention period ]
    Perceived exertion during training, measured with the Borg Rating of perceived exertion scale (RPE)
  • Applicability of the interventions [ Time Frame: Through the whole 3-month intervention period ]
    Adverse events, discomfort or chest pain during training measured with the Borg Category ratio scale (CR-10).
  • Applicability of the interventions [ Time Frame: Through the whole 3-month intervention period ]
    Affective state during training session using Feeling Scale, range -5 to 5, higher score indicates better feeling.
  • Experiences of exercising and its effects [ Time Frame: 3 months, 9 months. ]
    Focus group interviews.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Umeå High-Intensity Training Study
Official Title  ICMJE The Umeå High-Intensity Training Study: Feasibility and Effect of High-Intensity Training in Older Sedentary People
Brief Summary This randomized controlled trial will evaluate the effect of high-intensity training (HIT) in older sedentary people. Seventy older people, aged 65 and over, will be randomized to HIT or moderate-intensity continuous training (MICT). HIT sessions will consist of 10 repeated 6-seconds regulated high intensity cycling sprints against an individualized load. MICT (control group) sessions will consist of aerobic training regulated against an individualized load set to reach a moderate submaximal exercise intensity. Both groups will be performed twice weekly for 12 weeks. The study will evaluate the effects on 1) Cardiovascular function, 2) Brain health, 3) Muscular function, 4) Psychological health, 5) Physical activity, 6) Metabolic health, and 7) Examine the feasibility (attendance, achieved intensity, adverse events) as well as the experiences of HIT. Most outcomes will be assessed at baseline, 3 months (directly after intervention period), and 9 months by blinded assessors.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Masking Description:
The outcome assessors will be masked to group allocation. The participants will be given repeated instructions not to reveal their group allocation to the outcome assessors. Data set will be blinded regarding group allocation (and the code for the groups will be held by a researcher not involved in the study) when performing analyses for main outcomes.
Primary Purpose: Treatment
Condition  ICMJE Aged
Intervention  ICMJE
  • Other: High-intensity training
    Sessions will be performed twice weekly for 12 weeks, in groups of 8-10 participants and two supervisors.
  • Other: Moderate-intensity continuous training
    Sessions will be performed twice weekly for 12 weeks, in groups of 8-10 participants and two supervisors.
Study Arms  ICMJE
  • Experimental: High-intensity training
    Each high-intensity training (HIT) session will consist of 10 repeated 6-seconds regulated high intensity cycling sprints against an individualized load set to reach a supramaximal exercise intensity (i.e. power output is higher than power output at maximum oxygen uptake). Session duration for HIT is 20 min, including warm-up and cool-down. The protocol enables controlled and systematic adjustments of training intensity by means of standardized criteria.
    Intervention: Other: High-intensity training
  • Active Comparator: Moderate-intensity continuous training
    Each moderate-intensity continuous training (MICT) session will consist of aerobic training regulated against an individualized load set to reach a moderate submaximal exercise intensity (i.e. power output is lower than power output at maximum oxygen uptake). Session duration for MICT is 40 min, including warm-up and cool-down. The protocol enables controlled and systematic adjustments of training intensity by means of standardized criteria.
    Intervention: Other: Moderate-intensity continuous training
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: December 3, 2018)
70
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2020
Estimated Primary Completion Date June 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Not regularly physically active at moderate or high intensity over the last year.
  • Independent in activities of daily living (ADL) and able to transfer from home to exercise facility.

Exclusion Criteria:

  • Chronic and progressive neurological diseases.
  • Movement related conditions and functions (e.g. pain) or heart and lung conditions and diseases that prohibit exercise or tests, based on screening by a physician.
  • Cognitive impairment (Mini-Mental State Examination score below 27)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 65 Years and older   (Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Erik Rosendahl, Professor +46907869137 erik.rosendahl@umu.se
Contact: Carl-Johan Boraxbekk, Professor +46907866212 carl-johan.boraxbekk@umu.se
Listed Location Countries  ICMJE Sweden
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03765385
Other Study ID Numbers  ICMJE Dnr 2018‐307‐31M
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Umeå University
Study Sponsor  ICMJE Umeå University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Erik Rosendahl, Professor Umeå University
Principal Investigator: Carl-Johan Boraxbekk, Professor Umeå University
PRS Account Umeå University
Verification Date November 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP