AgingPoKuNCT02413112
Get in Shape in the Team Research: Porukalla Kuntoon Tutkimus
A study testing Resistance training in people with Aging and Muscle Strength, run by University of Jyvaskyla.
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. Read more about this study
- Who is it for?
- Ages 65 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Aging, Muscle Strength
- What is being tested?
- Resistance training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- No sites listed yet
- Study dates
- Jan 2015to Jun 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 75 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- BMI<37
- Does not smoke
- Able to perform all tests and exercises
- Free from episodes during physical activity
Who cannot join
- 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
About this study
Official title: 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.
Read more
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.
- Conditions
- Aging, Muscle Strength
- Being tested
- Resistance training
- Keywords
- Aging, Sarcopenia, Resistance training, Strength, Muscle mass
- Medical subject headings
- Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resistance trainingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Training once per week | Experimental | Subjects train once per week in the University gym. All training sessions are supervised by the researchers. Receives: Behavioral: Resistance training |
| Training twice per week | Experimental | Subjects train twice per week in the University gym. All training sessions are supervised by the researchers. Receives: Behavioral: Resistance training |
| Thrice per week | Experimental | Subjects train three times per week in the University gym. All training sessions are supervised by the researchers. Receives: Behavioral: Resistance training |
| Non-training Control group | No intervention | Subjects continue with their normal daily lives, just performing measurements |
What is being measured
The primary outcome is the main question the study is designed to answer.
Force production (Isometric and dynamic maximum strength tests of lower limbs)
Isometric and dynamic maximum strength tests of lower limbs
Measured: 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)
Cross-sectional area of quadriceps and triceps surae muscles
Measured: Change from baseline at 3, 9 and 15 months with data presented at 24 months post-initiation
Secondary outcomes (4)
Body composition (DXA scanning)
for body fat and fat-free mass
Measured: Change from baseline at 3, 9 and 15 months with data presented at 24 months post-initiation
Blood count
Basic blood count
Measured: Change from baseline at 3, 9 and 15 months with data presented at 24 months post-initiation
Oral glucose tolerance test
Oral glucose tolerance test assessed for glucose and insulin concentrations
Measured: Change from baseline at 3, 9 and 15 months with data presented at 24 months post-initiation
Basal hormone concentrations
Basal hormone concentrations from serum
Measured: Change from baseline at 3, 9 and 15 months with data presented at 24 months post-initiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2015 (estimated)
- Study startJan 2015
- Primary completionDec 2015
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AgingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Jyvaskyla
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Simon Walker, University of Jyvaskyla
- Investigators
- Simon Walker, Ph.D, Principal investigator, Univeristy of Jyvasklya
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02413112
- Sponsor's protocol ID
- OKM/70/626/2014
- Acronym
- PoKu
- Status last verified
- Oct 2016
- First submitted
- 19 Feb 2015
- Last updated
- 25 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Minimum Resistance Training Frequency: Effect on Motivation and Adherence to Train, Overall Health Status and Neuromuscular Performance
- ClinicalTrials.gov ID
- NCT02413112
- Acronym / sponsor ID
- PoKu / OKM/70/626/2014
- Conditions
- Aging, Muscle Strength
- Keywords
- Aging, Sarcopenia, Resistance training, Strength, Muscle mass
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- University of JyvaskylaUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Dec 2015 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 9 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Training once per week | Experimental | Behavioral: Resistance trainingSubjects train once per week in the University gym. All training sessions are supervised by the researchers. |
| Training twice per week | Experimental | Behavioral: Resistance trainingSubjects train twice per week in the University gym. All training sessions are supervised by the researchers. |
| Thrice per week | Experimental | Behavioral: Resistance trainingSubjects train three times per week in the University gym. All training sessions are supervised by the researchers. |
| Non-training Control group | No intervention | –Subjects continue with their normal daily lives, just performing measurements |
Who may qualify
- Ages
- 65 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- BMI<37
- Does not smoke
- Able to perform all tests and exercises
- Free from episodes during physical activity
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Resistance trainingWhole-body resistance training in the University gym that is supervised by researchers. Training once per week, Training twice per week, Training thrice per week. | Behavioural | Thrice per week, Training once per week, Training twice per week |
Primary outcome
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
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
4 secondary outcomes
Body composition (DXA scanning)
Time frame: 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
Oral glucose tolerance test
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2016.
Related trials for Aging
RecruitingPhase 2
Neuroplasticity Enhancement From Cognitive Training Reinforced by Psilocybin
Alzheimer's Disease
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
RecruitingPhase 2
Metformin as an add-on or Monotherapy in Treatment of Aging People With Multiple Sclerosis (MS)
Multiple Sclerosis
Not yet recruitingPhase 2
Validation & Intervention Testing for Aging, Longevity and Healthspan
Aging, Functional Decline
RecruitingObservational study
Effects of Obesity on Physical Abilities and Daily Living Activities in Elderly Adults
Obesity, Sarcopenic Obesity
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Simon Walker, Ph.D principal investigator
Univeristy of Jyvasklya
Questions about this trial
What is this clinical trial studying?
A study testing Resistance training in people with Aging and Muscle Strength, run by University of Jyvaskyla.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Oct 2016.