The Umeå High-Intensity Training Study

NCT ID: NCT03765385

Last Updated: 2020-10-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

68 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-12-13

Study Completion Date

2020-07-10

Brief Summary

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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

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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

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Aged

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors
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.

Study Groups

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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.

Group Type EXPERIMENTAL

High-intensity training

Intervention Type OTHER

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

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.

Group Type ACTIVE_COMPARATOR

Moderate-intensity continuous training

Intervention Type OTHER

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

Interventions

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High-intensity training

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

Intervention Type OTHER

Moderate-intensity continuous training

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

Intervention Type OTHER

Eligibility Criteria

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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)
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Umeå University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Erik Rosendahl, Professor

Role: PRINCIPAL_INVESTIGATOR

Umeå University

Carl-Johan Boraxbekk, Professor

Role: PRINCIPAL_INVESTIGATOR

Umeå University

Locations

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Umeå University

Umeå, , Sweden

Site Status

Countries

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Sweden

References

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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.

Reference Type DERIVED
PMID: 36972981 (View on PubMed)

Other Identifiers

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Dnr 2018-307-31M

Identifier Type: -

Identifier Source: org_study_id

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