The Umeå High-Intensity Training Study

NCT03765385 | Completed

• 1 other identifier: Dnr 2018-307-31M
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

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.

Conditions

Aged

Keywords

Aged; Aged, 80 and over; Exercise

Outcome Measures

Primary Outcomes (2)

• Change from baseline cardiovascular capacity at 3 months and at 9 months, respectively.

  Maximum oxygen uptake (VO2 max)

  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.

  Baseline, 3 months, 9 months

Secondary Outcomes (31)

• Change from baseline brain function at 3 months.

  Baseline, 3 months

• Change from baseline brain structure at 3 months.

  Baseline, 3 months

• Change from baseline strength in knee extensors at 3 months and at 9 months, respectively.

  Baseline, 3 months, 9 months

• Change from baseline hand grip strength at 3 months and at 9 months, respectively.

  Baseline, 3 months, 9 months

• Change from baseline leg extensor muscle power at 3 months and at 9 months, respectively.

  Baseline, 3 months, 9 months

Study Arms (2)

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.

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.

Other: Moderate-intensity continuous training

Interventions

High-intensity training OTHER

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

High-intensity training

Moderate-intensity continuous training OTHER

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

Moderate-intensity continuous training

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Umeå University: lead

Study Sites (1)

Umeå University

Umeå, Sweden

Location

Related Publications (1)

• 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.

  PMID: 36972981 DERIVED

MeSH Terms

Conditions

Motor Activity

Interventions

High-Intensity Interval Training

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Erik Rosendahl, Professor

  Umeå University

  PRINCIPAL INVESTIGATOR

• Carl-Johan Boraxbekk, Professor

  Umeå University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 26, 2018
• First Posted: December 5, 2018
• Study Start: December 13, 2018
• Primary Completion: February 5, 2020
• Study Completion: July 10, 2020
• Last Updated: October 5, 2020

Record last verified: 2020-09

Locations

SE (1)