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Completed

NCT Number: NCT03765385

The Umeå High-Intensity Training Study

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.

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Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Umeå University

Umeå, Sweden

About this study

Information about modifications of the study protocol (September 2020): Experiences of exercising and its effects were at the 9-month follow-up collected through individual interviews instead of focus group interviews (secondary outcome measures no. 31). Due to Covid-19, at the 9-month follow-up all outcome measurements besides the questionnaire (secondary outcome measures no 9, 10, 11, 12, and 14) and interviews (secondary outcome measure no 31) were terminated for 37 of the participants.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

High-intensity training

Other

Sessions will be performed twice weekly for 12 weeks, in groups of 8-10 participants and two supervisors.

Moderate-Intensity Continuous Training

Other

Sessions will be performed twice weekly for 12 weeks, in groups of 8-10 participants and two supervisors.

Primary outcomes

  1. 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)

  2. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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).

  4. 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).

  5. 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).

  6. 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.

  7. 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).

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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).

  13. 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.

  14. 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.

  15. 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,

  16. 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.

  17. 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.

  18. 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.

  19. 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.

  20. 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.

  21. 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.

  22. 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.

  23. 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).

  24. Applicability of the interventions

    Time frame: Through the whole 3-month intervention period

    Attendance: number of sessions attended.

  25. Applicability of the interventions

    Time frame: Through the whole 3-month intervention period

    Absolute work-load during training in Watt.

  26. Applicability of the interventions

    Time frame: Through the whole 3-month intervention period

    Relative training intensity, as percentage of MAP (Maximum Aerobic Power output).

  27. Applicability of the interventions

    Time frame: Through the whole 3-month intervention period

    Relative training intensity, as percentage of MHR (maximum heart rate).

  28. 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)

  29. 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).

  30. 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.

  31. Experiences of exercising and its effects

    Time frame: 3 months, 9 months.

    Focus group interviews.

Sponsors and collaborators

Lead sponsor

Umeå University

Other

Registry information

Official study title

The Umeå High-Intensity Training Study: Feasibility and Effect of High-Intensity Training in Older Sedentary People

Acronym: Umeå HIT

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Dec 5, 2018
Registry last updated
Oct 5, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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