The Umeå High-Intensity Training Study

Not Applicable

Completed

• Conditions: Aged
• Interventions: Other: High-intensity training; Other: Moderate-intensity continuous training

• Registration Number: NCT03765385
• Lead Sponsor: Umeå University

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 Timeline

• Study First Submitted: 2018-11-26
• Study First Submitted QC: 2018-12-03
• Study First Posted: 2018-12-05
• Study Start: 2018-12-13
• Primary Completion: 2020-02-05
• Study Completion: 2020-07-10
• Status Verified: 2020-09
• Last Update Submitted: 2020-10-02
• Last Update Posted: 2020-10-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 68

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
High-intensity training	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.
Moderate-intensity continuous training	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.

Primary Outcome Measures

Name	Time	Method
Change from baseline cardiovascular capacity at 3 months and at 9 months, respectively.	Baseline, 3 months, 9 months	Maximum oxygen uptake (VO2 max)
Change from baseline cognitive function at 3 months and at 9 months, respectively.	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 Outcome Measures

Name	Time	Method
Change from baseline sleep quality at 3 months and at 9 months, respectively.	Baseline, 3 months, 9 months	One question (no. 3) regarding sleep from Montgomery-Åsberg Depression Rating Scale (MADRS).
Experiences of exercising and its effects	3 months, 9 months.	Focus group interviews.
Change from baseline inflammation markers at 3 months and at 9 months, respectively.	Baseline, 3 months, 9 months	Interleukins in blood sample, units of measure is pg/ml.
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	Blood pressure at rest, measured as systolic ans diastolic pressure in mmHg.
Change from baseline functional performance at 3 months and at 9 months, respectively.	Baseline, 3 months, 9 months	Chair-stand test, number of chair-stands during 30 seconds.
Change from baseline health related quality of life at 3 months and at 9 months, respectively.	Baseline, 3 months, 9 months	Short Form Health Survey (SF-36): scores transformed to 0 to 100, higher scores indicates better quality of life.
Change from baseline brain function at 3 months.	Baseline, 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.
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	Resting heart rate, measured as beats per minute.
Change from baseline brain structure at 3 months.	Baseline, 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.
Change from baseline strength in knee extensors at 3 months and at 9 months, respectively.	Baseline, 3 months, 9 months	Maximal isometric strength in knee extensor measured as normalized joint torque in newton meters per kilogram bodyweight (Nm/kg).
Change from baseline hand grip strength at 3 months and at 9 months, respectively.	Baseline, 3 months, 9 months	Maximal hand grip strength measured as normalized force in Newtons per kilogram bodyweight (N/kg).
Change from baseline leg extensor muscle power at 3 months and at 9 months, respectively.	Baseline, 3 months, 9 months	Leg extensor power in the Nottingham Power Rig, measured as peak power output (watt).
Change from baseline functional balance at 3 months and at 9 months, respectively.	Baseline, 3 months, 9 months	Step test, number of steps during 30 seconds.
Change from baseline anxiety and depression at 3 months and at 9 months, respectively.	Baseline, 3 months, 9 months	Hospital anxiety and depression scale (HAD): range 0-42, higher score indicates more symptoms.
Change from baseline self-efficacy at 3 months and at 9 months, respectively.	Baseline, 3 months, 9 months	Swedish Exercise Self Efficacy Scale (ESES-S): Range 10-40, higher score indicates more self efficacy.
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	Physical activity measured by an activity monitor, the Actigraph. Number of steps per day and number of activity counts per day will be measured.
Change from baseline metabolic health at 3 months and at 9 months, respectively.	Baseline, 3 months, 9 months	Oral glucose tolerance test (OGTT):blood glucose in mmol/l,
Change from baseline lipid profile at 3 months and at 9 months, respectively.	Baseline, 3 months, 9 months	Lipid profile, measured by total cholesterol as well as separately as LDL- cholesterol and HDL-cholesterol. Unit of measure is mmol/l.
Change from baseline neurotrophic factors at 3 months and at 9 months, respectively.	Baseline, 3 months, 9 months	Brain-derived neurotrophic factor (BDNF), units of measure is pg/ml.
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	Two indicator questions on physical activity from the Swedish National Board of Health and Welfare.
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	Heart rate variability (HRV), measured in the time domain (e.g. RMSSD) and frequency domain (LF:HF).
Applicability of the interventions	Through the whole 3-month intervention period	Affective state during training session using Feeling Scale, range -5 to 5, higher score indicates better feeling.

Trial Locations

Locations (1)

Umeå University; 🇸🇪 Umeå, Sweden