NCT02413112

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
105

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2015

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 19, 2015

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 9, 2015

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

October 25, 2016

Status Verified

October 1, 2016

Enrollment Period

11 months

First QC Date

February 19, 2015

Last Update Submit

October 24, 2016

Conditions

Keywords

AgingSarcopeniaResistance trainingStrengthMuscle mass

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

Secondary Outcomes (4)

  • Body composition (DXA scanning)

    Change from baseline at 3, 9 and 15 months with data presented at 24 months post-initiation

  • Blood count

    Change from baseline at 3, 9 and 15 months with data presented at 24 months post-initiation

  • Oral glucose tolerance test

    Change from baseline at 3, 9 and 15 months with data presented at 24 months post-initiation

  • Basal hormone concentrations

    Change from baseline at 3, 9 and 15 months with data presented at 24 months post-initiation

Study Arms (4)

Training once per week

EXPERIMENTAL

Subjects train once per week in the University gym. All training sessions are supervised by the researchers.

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.

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.

Behavioral: Resistance training

Non-training Control group

NO INTERVENTION

Subjects continue with their normal daily lives, just performing measurements

Interventions

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.

Thrice per weekTraining once per weekTraining twice per week

Eligibility Criteria

Age65 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • BMI\<37
  • Does not smoke
  • Able to perform all tests and exercises
  • Free from episodes during physical activity

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Sarcopenia

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

Muscular AtrophyNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsSigns and Symptoms

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPhysical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Simon Walker, Ph.D

    Univeristy of Jyvasklya

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Post-doctoral researcher

Study Record Dates

First Submitted

February 19, 2015

First Posted

April 9, 2015

Study Start

January 1, 2015

Primary Completion

December 1, 2015

Study Completion

June 1, 2016

Last Updated

October 25, 2016

Record last verified: 2016-10