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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02413112
Other study ID # OKM/70/626/2014
Secondary ID
Status Completed
Phase N/A
First received February 19, 2015
Last updated October 24, 2016
Start date January 2015
Est. completion date June 2016

Study information

Verified date October 2016
Source University of Jyvaskyla
Contact n/a
Is FDA regulated No
Health authority Finland: Ethics Committee
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 105
Est. completion date June 2016
Est. primary completion date December 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 65 Years to 75 Years
Eligibility 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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science


Related Conditions & MeSH terms


Intervention

Behavioral:
Resistance training
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.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
University of Jyvaskyla

Outcome

Type Measure Description Time frame Safety issue
Primary Force production (Isometric and dynamic maximum strength tests of lower limbs) 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 Yes
Primary Muscle hypertrophy (Cross-sectional area of quadriceps and triceps surae muscles) 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 No
Secondary Body composition (DXA scanning) for body fat and fat-free mass Change from baseline at 3, 9 and 15 months with data presented at 24 months post-initiation Yes
Secondary Blood count Basic blood count Change from baseline at 3, 9 and 15 months with data presented at 24 months post-initiation Yes
Secondary Oral glucose tolerance test 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 Yes
Secondary Basal hormone concentrations Basal hormone concentrations from serum Change from baseline at 3, 9 and 15 months with data presented at 24 months post-initiation Yes
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