The Umeå High-Intensity Training Study: Feasibility and Effect of High-Intensity Training in Older Sedentary People
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Umeå University
- Enrollment
- 68
- Locations
- 1
- Primary Endpoint
- Change from baseline cardiovascular capacity at 3 months and at 9 months, respectively.
Study Overview
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.
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
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Investigator, Outcomes Assessor)
Masking Description
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.
Eligibility Criteria
- Ages
- 65 Years to — (Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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)
Arms & Interventions
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.
Intervention: High-intensity training (Other)
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.
Intervention: Moderate-intensity continuous training (Other)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Change from baseline functional balance at 3 months and at 9 months, respectively.(Baseline, 3 months, 9 months)
- Change from baseline inflammation markers at 3 months and at 9 months, respectively.(Baseline, 3 months, 9 months)
- Change from baseline neurotrophic factors at 3 months and at 9 months, respectively.(Baseline, 3 months, 9 months)
- Applicability of the interventions(Through the whole 3-month intervention period)
- Change from baseline resting heart rate at 1.5 months (mid-training), at 3 months and at 9 months, respectively.(Baseline, 1.5 months, 3 months, 9 months)
- Change from baseline self-efficacy at 3 months and at 9 months, respectively.(Baseline, 3 months, 9 months)
- Change from baseline lipid profile at 3 months and at 9 months, respectively.(Baseline, 3 months, 9 months)
- Change from baseline sleep quality at 3 months and at 9 months, respectively.(Baseline, 3 months, 9 months)
- Experiences of exercising and its effects(3 months, 9 months.)
- Change from baseline functional performance at 3 months and at 9 months, respectively.(Baseline, 3 months, 9 months)
- Change from baseline health related quality of life at 3 months and at 9 months, respectively.(Baseline, 3 months, 9 months)
- Change from baseline blood pressure at 1.5 months (mid-training), at 3 months and at 9 months, respectively.(Baseline, 1.5 months, 3 months, 9 months)
- 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)
- Change from baseline anxiety and depression at 3 months and at 9 months, respectively.(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.(Baseline, 1.5 months, 3 months, 9 months)
- Change from baseline metabolic health at 3 months and at 9 months, respectively.(Baseline, 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.(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.(Baseline, 1.5 months, 3 months, 9 months)