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Effects Resistance Training on Motor Control and Cognition (KFPS_2)

Primary Purpose

Muscle Weakness

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Stable Resistance Training
Unstable Resistance Training
Adductor/Abductor Resistance Training
Sponsored by
University of Kassel
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Muscle Weakness focused on measuring Motor Control, Balance

Eligibility Criteria

65 Years - 80 Years (Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • between 65 and 80 years old
  • ability to walk independently without any gait aid

Exclusion Criteria:

  • pathological ratings of the Clock Drawing Test (CDT),
  • Mini-Mental-State-Examination (MMSE, < 24 points),
  • Falls Efficacy Scale - International (FES-I, > 24 points),
  • Geriatric Depression Scale (GDS, > 9 points),
  • Freiburg Questionnaire of Physical Activity (FQoPA, < 1hour)
  • Frontal Assessment Battery (FAB-D, < 18 points)
  • any neurological, musculoskeletal or heart-related disease

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Active Comparator

    Experimental

    Experimental

    Arm Label

    M-SRT

    F-URT

    M-ART

    Arm Description

    Machine-based stable resistance training. Exercising 'traditional' machine-based resistance training.

    Free weight unstable resistance training; conducted free-weight resistance training on unstable devices using dumbbells instead of exercise-machines.

    Machine-based adductor/abductor resistance training. Exercising with 'traditional' adductor/abductor machines.

    Outcomes

    Primary Outcome Measures

    Clinical Gait Analysis
    changes in variance components (Vucm, Vort, Vtot) of an uncontrolled manifold analysis; measured in rad²

    Secondary Outcome Measures

    Maximal isometric leg extension strength (ILES)
    change in isometric strength, measured in N
    Fall self-efficacy Questionnaire
    change in anxiety score
    Proactivec Balance (timed up and go test)
    change in leg strength and procative balance (seconds)
    Maximal isometric adductor and abductor strength
    change in isometric strength, measured in N
    Stroop Task
    change in reaction time to congruent and incongruent stimuli (ms)
    Proactivec Balance (multidirectional reach test)
    change in proactive balance (cm)
    Power tests (chair rise test)
    change in muscle power (seconds)

    Full Information

    First Posted
    January 4, 2017
    Last Updated
    February 6, 2018
    Sponsor
    University of Kassel
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03017365
    Brief Title
    Effects Resistance Training on Motor Control and Cognition
    Acronym
    KFPS_2
    Official Title
    Effects of Different Resistance Training Methods on Strength, Motor Control and Executive Functions in Older Adults
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2017 (Actual)
    Primary Completion Date
    April 1, 2017 (Actual)
    Study Completion Date
    April 1, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University of Kassel

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    It is well documented that both balance and resistance training have the potential to mitigate intrinsic fall risk factors in older adults. Recently, it was shown that a simultaneously executed balance and resistance training, namely resistance training on uneven surfaces is an eligible, effective and safe alternative training program to mitigate intrinsic fall risk factors in older adults. However, knowledge about the effects of specific adductor and abductor training has advantages over traditional resistance training and resistance training on unstable surfaces regarding forward propulsion. Further, the effects of different kinds of resistance training on cognition, especially embodiment is investigated.
    Detailed Description
    Introduction: In the course of ageing, physical abilities decline and consequently there is an increase in risk of falling and fall incidences. Notwithstanding, the fact that causes of falls are multifactorial, losses in lower-extremity muscle strength, power and balance seem to be the most prominent intrinsic (i.e., person-related) fall risk factors in older adults. Several systematic reviews and meta-analyses highlighted the positive effects of resistance and balance training when applied as a single means, on measures of leg muscle strength, power and balance in older adults. Recently, it was shown that a simultaneously executed balance and resistance training, namely resistance training on uneven surfaces is an eligible, effective and safe alternative training program to mitigate intrinsic fall risk factors in older adults. Based on several investigations, it can be safely assumed that exercises conducted on unstable devices activate smaller muscles and stabilising function of bigger muscle groups. This facilitates torque and power transfer from lower to upper extremeties and is possibly responsible for similar effects as compared to stable resistance training despite lower loads. However, it is unknown if resistance training targeting adductor and abductor muscles induces similar results as compared to resistance training conducted on uneven surfaces. Moreover, physical activity has proven to affect cognitive measures positively, especially executive functions. It has yet to be determined to what extent different kinds of resistance training affect executive functions. Methods/Design: This study is a three-arm, 10-week RCT with a 10-week no-contact follow-up. Participants were randomly allocated (1:1) to either: 1) machine-based stable resistance training (M-SRT); 2) free-weight unstable resistance training (F-URT); 3) machine-based adductor and abductor resistance training. The design and reporting of this study follows the CONSORT (Consolidated Standards of Reporting Trials) 2010 Statement for parallel group randomised trials. Setting Participants are recruited from the communities in and around Kassel, Germany. Screening visits, measurement sessions, and the interventions are held at the Insitute of Sports and Sports Science / University of Kassel, Germany. Recruitment strategies: Recruitment is carried out by placing 1) an advertisement in the local newspaper, 2) during a public information meeting at the local town hall and 3) word of mouth. Interested individuals contact the study coordinator by phone, where they are provided with a brief description of the study. If responses suggest study eligibility then interested individuals are invited to attend a formal in-person screening visit. Participants:Older adults are eligible if they: 1) are aged between 65 and 80 years old 2) and able to walk independently for more than 10m. An a priori power analysis using G*Power 3.1 with an assumed type I error of .05 and a type II error of .10 (90% statistical power, correlation among groups: .5, nonsphericity correction: 1) was computed to determine an appropriate sample size to detect medium (.50 ≤ d ≤ .79) interaction effects. The calculations were based on a study assessing the effects of core strength training using unstable devices on older adults. The analysis revealed the requirement of 54 participants (18 per group) to obtain medium "time x group" interaction effects. Considering the likelihood of dropouts, at least 83 participants are going to be recruited to compensate for a possible dropout rate of ~20%. Interventions: All intervention groups train for ten weeks, twice per week on non-consecutive days for 60 minutes each. The 10-week intervention period consistes of a one week introductory phase and three major training blocks lasting three weeks each. Training intensity is progressively and individually increased over the 10-week training program by modulating load and sets for all groups and level of instability for F-URT. After week one (50 %), four (60%), and seven (70%) the training load (weight) is increased following one repetition maximum (1-RM) testing for each major exercise. M-SRT followes a 'traditional' machine-based stable resistance training program, including squats with a smith-machine and a leg press. F-URT conducts squats and front lunges on unstable devices. M-ART uses adductor and abductor strength training machines. All three intervention groups conduct a resistance training program consisting of two main exercises, a preparation and cool-down phase. Participants perform ten minutes of low-intensity stepping on a stair-walker as a brief warm-up at the beginning of each training session, followed by the resistance exercises and walking on a treadmill as cool-down. Training under unstable surface conditions, especially with additional weight, implies a certain degree of accident risk. Due to this factor, all instability exercises are observed by instructors and secured with additional aids like boxes. Training is supervised by skilled instructors at all times. For the first two weeks the participant to instructor ratio will be 5:1, thereafter 10:1. Outcome assessment: Outcomes are measured at baseline, 10 weeks (intervention endpoint) and 20 weeks (study endpoint). Measurement sessions are conducted on one day. Baseline data: Baseline measurements are obtained prior to randomisation. In addition to the measurements described below, the following are also collected: demographic and general health characteristics; medical history and medications; anthropometrics and rate of falls / near falls.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Muscle Weakness
    Keywords
    Motor Control, Balance

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    82 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    M-SRT
    Arm Type
    Active Comparator
    Arm Description
    Machine-based stable resistance training. Exercising 'traditional' machine-based resistance training.
    Arm Title
    F-URT
    Arm Type
    Experimental
    Arm Description
    Free weight unstable resistance training; conducted free-weight resistance training on unstable devices using dumbbells instead of exercise-machines.
    Arm Title
    M-ART
    Arm Type
    Experimental
    Arm Description
    Machine-based adductor/abductor resistance training. Exercising with 'traditional' adductor/abductor machines.
    Intervention Type
    Other
    Intervention Name(s)
    Stable Resistance Training
    Intervention Description
    traditional machine-based resistance training
    Intervention Type
    Other
    Intervention Name(s)
    Unstable Resistance Training
    Intervention Description
    free weight resistance training using unstable devices
    Intervention Type
    Other
    Intervention Name(s)
    Adductor/Abductor Resistance Training
    Intervention Description
    machine-based adductor/abductor resistance training
    Primary Outcome Measure Information:
    Title
    Clinical Gait Analysis
    Description
    changes in variance components (Vucm, Vort, Vtot) of an uncontrolled manifold analysis; measured in rad²
    Time Frame
    Pre test -> Intervention (10 weeks) -> Post test (within 2-5 days after the intervention)
    Secondary Outcome Measure Information:
    Title
    Maximal isometric leg extension strength (ILES)
    Description
    change in isometric strength, measured in N
    Time Frame
    Pre test -> Intervention (10 weeks) -> Post test (within 2-5 days after the intervention)
    Title
    Fall self-efficacy Questionnaire
    Description
    change in anxiety score
    Time Frame
    Pre test -> Intervention (10 weeks) -> Post test (within 2-5 days after the intervention)
    Title
    Proactivec Balance (timed up and go test)
    Description
    change in leg strength and procative balance (seconds)
    Time Frame
    Pre test -> Intervention (10 weeks) -> Post test (within 2-5 days after the intervention)
    Title
    Maximal isometric adductor and abductor strength
    Description
    change in isometric strength, measured in N
    Time Frame
    Pre test -> Intervention (10 weeks) -> Post test (within 2-5 days after the intervention)
    Title
    Stroop Task
    Description
    change in reaction time to congruent and incongruent stimuli (ms)
    Time Frame
    Pre test -> Intervention (10 weeks) -> Post test (within 2-5 days after the intervention)
    Title
    Proactivec Balance (multidirectional reach test)
    Description
    change in proactive balance (cm)
    Time Frame
    Pre test -> Intervention (10 weeks) -> Post test (within 2-5 days after the intervention)
    Title
    Power tests (chair rise test)
    Description
    change in muscle power (seconds)
    Time Frame
    Pre test -> Intervention (10 weeks) -> Post test (within 2-5 days after the intervention)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    65 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: between 65 and 80 years old ability to walk independently without any gait aid Exclusion Criteria: pathological ratings of the Clock Drawing Test (CDT), Mini-Mental-State-Examination (MMSE, < 24 points), Falls Efficacy Scale - International (FES-I, > 24 points), Geriatric Depression Scale (GDS, > 9 points), Freiburg Questionnaire of Physical Activity (FQoPA, < 1hour) Frontal Assessment Battery (FAB-D, < 18 points) any neurological, musculoskeletal or heart-related disease
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Armin Kibele, PhD
    Organizational Affiliation
    University of Kassel
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    Raw results will be published. Age will be described as intervals (65-69, 70-74, 75-80) and height will be removed, thus no backtracking is possible
    IPD Sharing Time Frame
    when the article is published
    IPD Sharing Access Criteria
    IPD will be published as supplementary material. Raw results will be published. Age will be described as intervals (65-69, 70-74, 75-80) and height will be removed, thus no backtracking is possible
    Citations:
    PubMed Identifier
    27881086
    Citation
    Eckardt N. Lower-extremity resistance training on unstable surfaces improves proxies of muscle strength, power and balance in healthy older adults: a randomised control trial. BMC Geriatr. 2016 Nov 24;16(1):191. doi: 10.1186/s12877-016-0366-3.
    Results Reference
    background
    PubMed Identifier
    22315687
    Citation
    Granacher U, Muehlbauer T, Gruber M. A qualitative review of balance and strength performance in healthy older adults: impact for testing and training. J Aging Res. 2012;2012:708905. doi: 10.1155/2012/708905. Epub 2012 Jan 23.
    Results Reference
    background
    PubMed Identifier
    12757574
    Citation
    Steadman J, Donaldson N, Kalra L. A randomized controlled trial of an enhanced balance training program to improve mobility and reduce falls in elderly patients. J Am Geriatr Soc. 2003 Jun;51(6):847-52. doi: 10.1046/j.1365-2389.2003.51268.x.
    Results Reference
    background
    PubMed Identifier
    26359066
    Citation
    Behm DG, Muehlbauer T, Kibele A, Granacher U. Effects of Strength Training Using Unstable Surfaces on Strength, Power and Balance Performance Across the Lifespan: A Systematic Review and Meta-analysis. Sports Med. 2015 Dec;45(12):1645-69. doi: 10.1007/s40279-015-0384-x. Erratum In: Sports Med. 2016 Mar;46(3):451.
    Results Reference
    background
    PubMed Identifier
    30873017
    Citation
    Eckardt N, Rosenblatt NJ. Instability Resistance Training Decreases Motor Noise During Challenging Walking Tasks in Older Adults: A 10-Week Double-Blinded RCT. Front Aging Neurosci. 2019 Feb 27;11:32. doi: 10.3389/fnagi.2019.00032. eCollection 2019.
    Results Reference
    derived

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    Effects Resistance Training on Motor Control and Cognition

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