Umeå University
Umeå, Sweden
NCT Number: NCT03765385
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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Notify Me65 year and older
All sexes
Interventional
Not applicable
Umeå, Sweden
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Sessions will be performed twice weekly for 12 weeks, in groups of 8-10 participants and two supervisors.
Sessions will be performed twice weekly for 12 weeks, in groups of 8-10 participants and two supervisors.
Time frame: Baseline, 3 months, 9 months
Maximum oxygen uptake (VO2 max)
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.
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.
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.
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).
Time frame: Baseline, 3 months, 9 months
Maximal hand grip strength measured as normalized force in Newtons per kilogram bodyweight (N/kg).
Time frame: Baseline, 3 months, 9 months
Leg extensor power in the Nottingham Power Rig, measured as peak power output (watt).
Time frame: Baseline, 3 months, 9 months
Chair-stand test, number of chair-stands during 30 seconds.
Time frame: Baseline, 3 months, 9 months
One-leg stance: number of seconds able to stand on one leg (maximum 120 seconds).
Time frame: Baseline, 3 months, 9 months
Step test, number of steps during 30 seconds.
Time frame: Baseline, 3 months, 9 months
Hospital anxiety and depression scale (HAD): range 0-42, higher score indicates more symptoms.
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.
Time frame: Baseline, 3 months, 9 months
Swedish Exercise Self Efficacy Scale (ESES-S): Range 10-40, higher score indicates more self efficacy.
Time frame: Baseline, 3 months, 9 months
One question (no. 3) regarding sleep from Montgomery-Åsberg Depression Rating Scale (MADRS).
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.
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.
Time frame: Baseline, 3 months, 9 months
Oral glucose tolerance test (OGTT):blood glucose in mmol/l,
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.
Time frame: Baseline, 3 months, 9 months
C-reactive protein (CRP) in blood sample, units of measure is mg/l.
Time frame: Baseline, 3 months, 9 months
Interleukins in blood sample, units of measure is pg/ml.
Time frame: Baseline, 3 months, 9 months
Insulin-like growth factor 1 (IGF-1), units of measure is pg/ml.
Time frame: Baseline, 3 months, 9 months
Brain-derived neurotrophic factor (BDNF), units of measure is pg/ml.
Time frame: Baseline, 1.5 months, 3 months, 9 months
Blood pressure at rest, measured as systolic ans diastolic pressure in mmHg.
Time frame: Baseline, 1.5 months, 3 months, 9 months
Resting heart rate, measured as beats per minute.
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).
Time frame: Through the whole 3-month intervention period
Attendance: number of sessions attended.
Time frame: Through the whole 3-month intervention period
Absolute work-load during training in Watt.
Time frame: Through the whole 3-month intervention period
Relative training intensity, as percentage of MAP (Maximum Aerobic Power output).
Time frame: Through the whole 3-month intervention period
Relative training intensity, as percentage of MHR (maximum heart rate).
Time frame: Through the whole 3-month intervention period
Perceived exertion during training, measured with the Borg Rating of perceived exertion scale (RPE)
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).
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.
Time frame: 3 months, 9 months.
Focus group interviews.
Umeå University
Other
The Umeå High-Intensity Training Study: Feasibility and Effect of High-Intensity Training in Older Sedentary People
Acronym: Umeå HIT
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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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