AgedUmeå HITNCT03765385
The Umeå High-Intensity Training Study
A study testing High-intensity training and Moderate-intensity continuous training in people with Aged, run by Umeå University at 1 site in Sweden.
Trial 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). Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Aged
- What is being tested?
- High-intensity training and Moderate-intensity continuous training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteSweden
- Study dates
- 13 Dec 2018to 10 Jul 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Umeå High-Intensity Training Study: Feasibility and Effect of High-Intensity Training in Older Sedentary People
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.
Read the detailed description
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.
- Conditions
- Aged
- Being tested
- High-intensity training, Moderate-intensity continuous training
- Keywords
- Aged, Aged, 80 and over, Exercise
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-intensity trainingOther
Sessions will be performed twice weekly for 12 weeks, in groups of 8-10 participants and two supervisors.
Moderate-intensity continuous trainingOther
Sessions will be performed twice weekly for 12 weeks, in groups of 8-10 participants and two supervisors.
| Study group | Role | What they receive |
|---|---|---|
| High-intensity training | Experimental | 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. Receives: Other: High-intensity training |
| Moderate-intensity continuous training | Active comparator | 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. Receives: Other: Moderate-intensity continuous training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline cardiovascular capacity at 3 months and at 9 months, respectively.
Maximum oxygen uptake (VO2 max)
Measured: Baseline, 3 months, 9 months
Change from baseline cognitive function at 3 months and at 9 months, respectively.
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.
Measured: Baseline, 3 months, 9 months
Secondary outcomes (31)
Change from baseline brain function at 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.
Measured: Baseline, 3 months
Change from baseline brain structure at 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.
Measured: Baseline, 3 months
Change from baseline strength in knee extensors at 3 months and at 9 months, respectively.
Maximal isometric strength in knee extensor measured as normalized joint torque in newton meters per kilogram bodyweight (Nm/kg).
Measured: Baseline, 3 months, 9 months
Change from baseline hand grip strength at 3 months and at 9 months, respectively.
Maximal hand grip strength measured as normalized force in Newtons per kilogram bodyweight (N/kg).
Measured: Baseline, 3 months, 9 months
Change from baseline leg extensor muscle power at 3 months and at 9 months, respectively.
Leg extensor power in the Nottingham Power Rig, measured as peak power output (watt).
Measured: Baseline, 3 months, 9 months
Change from baseline functional performance at 3 months and at 9 months, respectively.
Chair-stand test, number of chair-stands during 30 seconds.
Measured: Baseline, 3 months, 9 months
Change from baseline functional balance at 3 months and at 9 months, respectively.
One-leg stance: number of seconds able to stand on one leg (maximum 120 seconds).
Measured: Baseline, 3 months, 9 months
Change from baseline functional balance at 3 months and at 9 months, respectively.
Step test, number of steps during 30 seconds.
Measured: Baseline, 3 months, 9 months
Change from baseline anxiety and depression at 3 months and at 9 months, respectively.
Hospital anxiety and depression scale (HAD): range 0-42, higher score indicates more symptoms.
Measured: Baseline, 3 months, 9 months
Change from baseline health related quality of life at 3 months and at 9 months, respectively.
Short Form Health Survey (SF-36): scores transformed to 0 to 100, higher scores indicates better quality of life.
Measured: Baseline, 3 months, 9 months
Change from baseline self-efficacy at 3 months and at 9 months, respectively.
Swedish Exercise Self Efficacy Scale (ESES-S): Range 10-40, higher score indicates more self efficacy.
Measured: Baseline, 3 months, 9 months
Change from baseline sleep quality at 3 months and at 9 months, respectively.
One question (no. 3) regarding sleep from Montgomery-Åsberg Depression Rating Scale (MADRS).
Measured: Baseline, 3 months, 9 months
Change from baseline objective physical activity at 1.5 months (mid-training), at 3 months and at 9 months, respectively.
Physical activity measured by an activity monitor, the Actigraph. Number of steps per day and number of activity counts per day will be measured.
Measured: Baseline, 1.5 months, 3 months, 9 months
Change from baseline self-reported physical activity at 1.5 months (mid-training), at 3 months and at 9 months, respectively.
Two indicator questions on physical activity from the Swedish National Board of Health and Welfare.
Measured: Baseline, 1.5 months, 3 months, 9 months
Change from baseline metabolic health at 3 months and at 9 months, respectively.
Oral glucose tolerance test (OGTT):blood glucose in mmol/l,
Measured: Baseline, 3 months, 9 months
Change from baseline lipid profile at 3 months and at 9 months, respectively.
Lipid profile, measured by total cholesterol as well as separately as LDL- cholesterol and HDL-cholesterol. Unit of measure is mmol/l.
Measured: Baseline, 3 months, 9 months
Change from baseline inflammation markers at 3 months and at 9 months, respectively.
C-reactive protein (CRP) in blood sample, units of measure is mg/l.
Measured: Baseline, 3 months, 9 months
Change from baseline inflammation markers at 3 months and at 9 months, respectively.
Interleukins in blood sample, units of measure is pg/ml.
Measured: Baseline, 3 months, 9 months
Change from baseline neurotrophic factors at 3 months and at 9 months, respectively.
Insulin-like growth factor 1 (IGF-1), units of measure is pg/ml.
Measured: Baseline, 3 months, 9 months
Change from baseline neurotrophic factors at 3 months and at 9 months, respectively.
Brain-derived neurotrophic factor (BDNF), units of measure is pg/ml.
Measured: Baseline, 3 months, 9 months
Change from baseline blood pressure at 1.5 months (mid-training), at 3 months and at 9 months, respectively.
Blood pressure at rest, measured as systolic ans diastolic pressure in mmHg.
Measured: Baseline, 1.5 months, 3 months, 9 months
Change from baseline resting heart rate at 1.5 months (mid-training), at 3 months and at 9 months, respectively.
Resting heart rate, measured as beats per minute.
Measured: Baseline, 1.5 months, 3 months, 9 months
Change from baseline autonomic function at 1.5 months (mid-training), at 3 months and at 9 months, respectively.
Heart rate variability (HRV), measured in the time domain (e.g. RMSSD) and frequency domain (LF:HF).
Measured: Baseline, 1.5 months, 3 months, 9 months
Applicability of the interventions
Attendance: number of sessions attended.
Measured: Through the whole 3-month intervention period
Applicability of the interventions
Absolute work-load during training in Watt.
Measured: Through the whole 3-month intervention period
Applicability of the interventions
Relative training intensity, as percentage of MAP (Maximum Aerobic Power output).
Measured: Through the whole 3-month intervention period
Applicability of the interventions
Relative training intensity, as percentage of MHR (maximum heart rate).
Measured: Through the whole 3-month intervention period
Applicability of the interventions
Perceived exertion during training, measured with the Borg Rating of perceived exertion scale (RPE)
Measured: Through the whole 3-month intervention period
Applicability of the interventions
Adverse events, discomfort or chest pain during training measured with the Borg Category ratio scale (CR-10).
Measured: Through the whole 3-month intervention period
Applicability of the interventions
Affective state during training session using Feeling Scale, range -5 to 5, higher score indicates better feeling.
Measured: Through the whole 3-month intervention period
Experiences of exercising and its effects
Focus group interviews.
Measured: 3 months, 9 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2018
- Study start13 Dec 2018
- Primary completion5 Feb 2020
- Study completion10 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AgedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Umeå University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Erik Rosendahl, Professor, Principal investigator, Umeå UniversityCarl-Johan Boraxbekk, Professor, Principal investigator, Umeå University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03765385
- Sponsor's protocol ID
- Dnr 2018-307-31M
- Acronym
- Umeå HIT
- Status last verified
- Sep 2020
- First submitted
- 26 Nov 2018
- Last updated
- 5 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Simonsson E, Levik Sandstrom S, Hedlund M, Holmberg H, Johansson B, Lindelof N, Boraxbekk CJ, Rosendahl E. Effects of Controlled Supramaximal High-Intensity Interval Training on Cardiorespiratory Fitness and Global Cognitive Function in Older Adults: The Umea HIT Study-A Randomized Controlled Trial. J Gerontol A Biol Sci Med Sci. 2023 Aug 27;78(9):1581-1590. doi: 10.1093/gerona/glad070.
PubMed 36972981
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Umeå High-Intensity Training Study: Feasibility and Effect of High-Intensity Training in Older Sedentary People
- ClinicalTrials.gov ID
- NCT03765385
- Acronym / sponsor ID
- Umeå HIT / Dnr 2018-307-31M
- Conditions
- Aged
- Keywords
- Aged, Aged, 80 and over, Exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Umeå UniversityUniversity, hospital or other
- Study start
- 13 Dec 2018 (actual)
- Primary completion
- 5 Feb 2020 (actual)
- Study completion
- 10 Jul 2020 (actual)
- First posted
- 5 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High-intensity training | Experimental | Other: High-intensity trainingEach 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. |
| Moderate-intensity continuous training | Active comparator | Other: Moderate-intensity continuous trainingEach 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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High-intensity trainingSessions will be performed twice weekly for 12 weeks, in groups of 8-10 participants and two supervisors. | Other | High-intensity training |
| Moderate-intensity continuous trainingSessions will be performed twice weekly for 12 weeks, in groups of 8-10 participants and two supervisors. | Other | Moderate-intensity continuous training |
Primary outcome
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.
31 secondary outcomes
Change from baseline brain function at 3 months.
Time frame: Baseline, 3 months
Change from baseline brain structure at 3 months.
Time frame: Baseline, 3 months
Change from baseline strength in knee extensors at 3 months and at 9 months, respectively.
Time frame: Baseline, 3 months, 9 months
Change from baseline hand grip strength at 3 months and at 9 months, respectively.
Time frame: Baseline, 3 months, 9 months
Change from baseline leg extensor muscle power at 3 months and at 9 months, respectively.
Time frame: Baseline, 3 months, 9 months
Change from baseline functional performance at 3 months and at 9 months, respectively.
Time frame: Baseline, 3 months, 9 months
Change from baseline functional balance at 3 months and at 9 months, respectively.
Time frame: Baseline, 3 months, 9 months
Change from baseline functional balance at 3 months and at 9 months, respectively.
Time frame: Baseline, 3 months, 9 months
Change from baseline anxiety and depression at 3 months and at 9 months, respectively.
Time frame: Baseline, 3 months, 9 months
Change from baseline health related quality of life at 3 months and at 9 months, respectively.
Time frame: Baseline, 3 months, 9 months
Change from baseline self-efficacy at 3 months and at 9 months, respectively.
Time frame: Baseline, 3 months, 9 months
Change from baseline sleep quality at 3 months and at 9 months, respectively.
Time frame: Baseline, 3 months, 9 months
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
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
Change from baseline metabolic health at 3 months and at 9 months, respectively.
Time frame: Baseline, 3 months, 9 months
Change from baseline lipid profile at 3 months and at 9 months, respectively.
Time frame: Baseline, 3 months, 9 months
Change from baseline inflammation markers at 3 months and at 9 months, respectively.
Time frame: Baseline, 3 months, 9 months
Change from baseline inflammation markers at 3 months and at 9 months, respectively.
Time frame: Baseline, 3 months, 9 months
Change from baseline neurotrophic factors at 3 months and at 9 months, respectively.
Time frame: Baseline, 3 months, 9 months
Change from baseline neurotrophic factors at 3 months and at 9 months, respectively.
Time frame: Baseline, 3 months, 9 months
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
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
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
Applicability of the interventions
Time frame: Through the whole 3-month intervention period
Applicability of the interventions
Time frame: Through the whole 3-month intervention period
Applicability of the interventions
Time frame: Through the whole 3-month intervention period
Applicability of the interventions
Time frame: Through the whole 3-month intervention period
Applicability of the interventions
Time frame: Through the whole 3-month intervention period
Applicability of the interventions
Time frame: Through the whole 3-month intervention period
Applicability of the interventions
Time frame: Through the whole 3-month intervention period
Experiences of exercising and its effects
Time frame: 3 months, 9 months.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2020.
- Derived from this study: PubMed 36972981Simonsson E, Levik Sandstrom S, Hedlund M, Holmberg H, Johansson B, Lindelof N, Boraxbekk CJ, Rosendahl E. Effects of Controlled Supramaximal High-Intensity Interval Training on Cardiorespiratory Fitness and Global Cognitive Function in Older Adults: The Umea HIT Study-A Randomized Controlled Trial. J Gerontol A Biol Sci Med Sci. 2023 Aug 27;78(9):1581-1590. doi: 10.1093/gerona/glad070.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Erik Rosendahl, Professor principal investigator
Umeå University
Carl-Johan Boraxbekk, Professor principal investigator
Umeå University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High-intensity training and Moderate-intensity continuous training in people with Aged, run by Umeå University at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline cardiovascular capacity at 3 months and at 9 months, respectively. (time frame: Baseline, 3 months, 9 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03765385, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2020.