- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02413112
Get in Shape in the Team Research: Porukalla Kuntoon Tutkimus (PoKu)
Minimum Resistance Training Frequency: Effect on Motivation and Adherence to Train, Overall Health Status and Neuromuscular Performance
It is well accepted that physical activity in the form of resistance training produces a wide variety of neuromuscular-skeletal and health benefits. It is recommended in Finland that older individuals (over 65yr) should perform resistance training twice per week.
Unfortunately, only approx. 5% of older individuals fulfill this recommendation. As Finnish society grows ever older, research should focus on the specific needs of this group and how to improve participation in physical activity, which may ultimately lead to modification of physical activity recommendations - resistance training recommendations are currently the same for young and older adults and do not include specific recommendations on the type of resistance training. However, these recommendations appear to have been developed for "best possible" improvements in maximum strength and muscle size.
Therefore, it is of great importance to identify the number of resistance training sessions per week required to induce improvements in physical fitness, metabolic and bone health status, and importantly the reasons for adherence to/drop-out of resistance training interventions (e.g. motivation to train) in a multi-discipline study. This knowledge would benefit policy makers to update current recommendations for resistance training and to devise strategies to advise realistic targets for resistance training in the older, particularly the less-educated, age group (e.g. TELI-strategy for 2020).
The present study will include a 12-month resistance training intervention with a 12-month follow-up period. Interviews and questionnaires will assess psychological/sociological data and will be collected from both drop-out subjects and those that complete the intervention. Neuromuscular performance and functional capacity will be tested using conventional methods, along with body composition, bone density, and blood tests for metabolic markers of health. Diet and other physical activity will be controlled throughout the intervention period. Measurements are to be performed every 3 months.
It is expected that 5 international peer-reviewed articles will be published in 2016-2017. The data will be presented at international and national conferences in 2015-2017. Finally, results of the entire research will be published in national peer-reviewed journals (e.g. The Age Institute's "Raportteja"). All subjects will be invited to attend an information meeting where group results will be presented and explained.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- BMI<37
- Does not smoke
- Able to perform all tests and exercises
- Free from episodes during physical activity
Exclusion Criteria:
- BMI>37
- Use of waling aids
- Previous testosterone-altering treatment, e.g. in cancer treatment or hypogonadism
- Serious cardiovascular disease that may lead to complications during exercise
- Use of pharmaceuticals that affect neuromuscular or endocrine systems
- Regular endurance training>3hr per week
- Resistance training experience
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Training once per week
Subjects train once per week in the University gym.
All training sessions are supervised by the researchers.
|
Whole-body resistance training in the University gym that is supervised by researchers. Training once per week, Training twice per week, Training thrice per week. |
|
Experimental: Training twice per week
Subjects train twice per week in the University gym.
All training sessions are supervised by the researchers.
|
Whole-body resistance training in the University gym that is supervised by researchers. Training once per week, Training twice per week, Training thrice per week. |
|
Experimental: Thrice per week
Subjects train three times per week in the University gym.
All training sessions are supervised by the researchers.
|
Whole-body resistance training in the University gym that is supervised by researchers. Training once per week, Training twice per week, Training thrice per week. |
|
No Intervention: Non-training Control group
Subjects continue with their normal daily lives, just performing measurements
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Force production (Isometric and dynamic maximum strength tests of lower limbs)
Time Frame: Change from baseline at 3, 9 and 15 months with data presented at 24 months post-initiation
|
Isometric and dynamic maximum strength tests of lower limbs
|
Change from baseline at 3, 9 and 15 months with data presented at 24 months post-initiation
|
|
Muscle hypertrophy (Cross-sectional area of quadriceps and triceps surae muscles)
Time Frame: Change from baseline at 3, 9 and 15 months with data presented at 24 months post-initiation
|
Cross-sectional area of quadriceps and triceps surae muscles
|
Change from baseline at 3, 9 and 15 months with data presented at 24 months post-initiation
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Body composition (DXA scanning)
Time Frame: Change from baseline at 3, 9 and 15 months with data presented at 24 months post-initiation
|
for body fat and fat-free mass
|
Change from baseline at 3, 9 and 15 months with data presented at 24 months post-initiation
|
|
Blood count
Time Frame: Change from baseline at 3, 9 and 15 months with data presented at 24 months post-initiation
|
Basic blood count
|
Change from baseline at 3, 9 and 15 months with data presented at 24 months post-initiation
|
|
Oral glucose tolerance test
Time Frame: Change from baseline at 3, 9 and 15 months with data presented at 24 months post-initiation
|
Oral glucose tolerance test assessed for glucose and insulin concentrations
|
Change from baseline at 3, 9 and 15 months with data presented at 24 months post-initiation
|
|
Basal hormone concentrations
Time Frame: Change from baseline at 3, 9 and 15 months with data presented at 24 months post-initiation
|
Basal hormone concentrations from serum
|
Change from baseline at 3, 9 and 15 months with data presented at 24 months post-initiation
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Simon Walker, Ph.D, Univeristy of Jyvasklya
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- OKM/70/626/2014
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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