Get in Shape in the Team Research: Porukalla Kuntoon Tutkimus (PoKu)

October 24, 2016 updated by: Simon Walker, University of Jyvaskyla

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
105

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

65 years to 75 years (Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Training once per week
Subjects train once per week in the University gym. All training sessions are supervised by the researchers.
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.
Experimental: Training twice per week
Subjects train twice per week in the University gym. All training sessions are supervised by the researchers.
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.
Experimental: Thrice per week
Subjects train three times per week in the University gym. All training sessions are supervised by the researchers.
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.
No Intervention: Non-training Control group
Subjects continue with their normal daily lives, just performing measurements

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Jyvaskyla

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Simon Walker, Ph.D, Univeristy of Jyvasklya

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 19, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 8, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 9, 2015

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 25, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 24, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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