Clinical trial NCT03765385: The Umeå High-Intensity Training Study
Official title: The Umeå High-Intensity Training Study: Feasibility and Effect of High-Intensity Training in Older Sedentary People
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aged
Keywords: Aged
Aged, 80 and over
Exercise
Lead sponsor: Umeå University
Sponsor class: OTHER
First posted: 2018-12-05
Enrollment: 68
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Change from baseline cardiovascular capacity at 3 months and at 9 months, respectively.
timeFrame: Baseline, 3 months, 9 months
measure: Change from baseline cognitive function at 3 months and at 9 months, respectively.
timeFrame: Baseline, 3 months, 9 months
Secondary outcomes:
measure: Change from baseline brain function at 3 months.
timeFrame: Baseline, 3 months
measure: Change from baseline brain structure at 3 months.
timeFrame: Baseline, 3 months
measure: Change from baseline strength in knee extensors at 3 months and at 9 months, respectively.
timeFrame: Baseline, 3 months, 9 months
measure: Change from baseline hand grip strength at 3 months and at 9 months, respectively.
timeFrame: Baseline, 3 months, 9 months
measure: Change from baseline leg extensor muscle power at 3 months and at 9 months, respectively.
timeFrame: Baseline, 3 months, 9 months
measure: Change from baseline functional performance at 3 months and at 9 months, respectively.
timeFrame: Baseline, 3 months, 9 months
measure: Change from baseline functional balance at 3 months and at 9 months, respectively.
timeFrame: Baseline, 3 months, 9 months
measure: Change from baseline functional balance at 3 months and at 9 months, respectively.
timeFrame: Baseline, 3 months, 9 months
measure: Change from baseline anxiety and depression at 3 months and at 9 months, respectively.
timeFrame: Baseline, 3 months, 9 months
measure: Change from baseline health related quality of life at 3 months and at 9 months, respectively.
timeFrame: Baseline, 3 months, 9 months
measure: Change from baseline self-efficacy at 3 months and at 9 months, respectively.
timeFrame: Baseline, 3 months, 9 months
measure: Change from baseline sleep quality at 3 months and at 9 months, respectively.
timeFrame: Baseline, 3 months, 9 months
measure: Change from baseline objective physical activity at 1.5 months (mid-training), at 3 months and at 9 months, respectively.
timeFrame: Baseline, 1.5 months, 3 months, 9 months
measure: Change from baseline self-reported physical activity at 1.5 months (mid-training), at 3 months and at 9 months, respectively.
timeFrame: Baseline, 1.5 months, 3 months, 9 months
measure: Change from baseline metabolic health at 3 months and at 9 months, respectively.
timeFrame: Baseline, 3 months, 9 months
measure: Change from baseline lipid profile at 3 months and at 9 months, respectively.
timeFrame: Baseline, 3 months, 9 months
measure: Change from baseline inflammation markers at 3 months and at 9 months, respectively.
timeFrame: Baseline, 3 months, 9 months
measure: Change from baseline inflammation markers at 3 months and at 9 months, respectively.
timeFrame: Baseline, 3 months, 9 months
measure: Change from baseline neurotrophic factors at 3 months and at 9 months, respectively.
timeFrame: Baseline, 3 months, 9 months
measure: Change from baseline neurotrophic factors at 3 months and at 9 months, respectively.
timeFrame: Baseline, 3 months, 9 months
measure: Change from baseline blood pressure at 1.5 months (mid-training), at 3 months and at 9 months, respectively.
timeFrame: Baseline, 1.5 months, 3 months, 9 months
measure: Change from baseline resting heart rate at 1.5 months (mid-training), at 3 months and at 9 months, respectively.
timeFrame: Baseline, 1.5 months, 3 months, 9 months
measure: Change from baseline autonomic function at 1.5 months (mid-training), at 3 months and at 9 months, respectively.
timeFrame: Baseline, 1.5 months, 3 months, 9 months
measure: Applicability of the interventions
timeFrame: Through the whole 3-month intervention period
measure: Applicability of the interventions
timeFrame: Through the whole 3-month intervention period
measure: Applicability of the interventions
timeFrame: Through the whole 3-month intervention period
measure: Applicability of the interventions
timeFrame: Through the whole 3-month intervention period
measure: Applicability of the interventions
timeFrame: Through the whole 3-month intervention period
measure: Applicability of the interventions
timeFrame: Through the whole 3-month intervention period
measure: Applicability of the interventions
timeFrame: Through the whole 3-month intervention period
measure: Experiences of exercising and its effects
timeFrame: 3 months, 9 months.
Other outcomes:
Locations:
city: Umeå
country: Sweden
facility: Umeå University
Study officials:
affiliation: Umeå University
name: Erik Rosendahl, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Umeå University
name: Carl-Johan Boraxbekk, Professor
role: PRINCIPAL_INVESTIGATOR
References: