NCT03017365

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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
82

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2017

Shorter than P25 for not_applicable

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, 2017

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

January 4, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 11, 2017

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2017

Completed
Last Updated

February 7, 2018

Status Verified

February 1, 2018

Enrollment Period

3 months

First QC Date

January 4, 2017

Last Update Submit

February 6, 2018

Conditions

Keywords

Motor ControlBalance

Outcome Measures

Primary Outcomes (1)

  • Clinical Gait Analysis

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

    Pre test -> Intervention (10 weeks) -> Post test (within 2-5 days after the intervention)

Secondary Outcomes (7)

  • Maximal isometric leg extension strength (ILES)

    Pre test -> Intervention (10 weeks) -> Post test (within 2-5 days after the intervention)

  • Fall self-efficacy Questionnaire

    Pre test -> Intervention (10 weeks) -> Post test (within 2-5 days after the intervention)

  • Proactivec Balance (timed up and go test)

    Pre test -> Intervention (10 weeks) -> Post test (within 2-5 days after the intervention)

  • Maximal isometric adductor and abductor strength

    Pre test -> Intervention (10 weeks) -> Post test (within 2-5 days after the intervention)

  • Stroop Task

    Pre test -> Intervention (10 weeks) -> Post test (within 2-5 days after the intervention)

  • +2 more secondary outcomes

Study Arms (3)

M-SRT

ACTIVE COMPARATOR

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

Other: Stable Resistance Training

F-URT

EXPERIMENTAL

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

Other: Unstable Resistance Training

M-ART

EXPERIMENTAL

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

Other: Adductor/Abductor Resistance Training

Interventions

traditional machine-based resistance training

M-SRT

free weight resistance training using unstable devices

F-URT

machine-based adductor/abductor resistance training

M-ART

Eligibility Criteria

Age65 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (5)

  • 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.

    PMID: 27881086BACKGROUND
  • 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.

    PMID: 22315687BACKGROUND
  • 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.

    PMID: 12757574BACKGROUND
  • 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.

    PMID: 26359066BACKGROUND
  • 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.

MeSH Terms

Conditions

Muscle Weakness

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsSigns and Symptoms

Study Officials

  • Armin Kibele, PhD

    University of Kassel

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 4, 2017

First Posted

January 11, 2017

Study Start

January 1, 2017

Primary Completion

April 1, 2017

Study Completion

April 1, 2017

Last Updated

February 7, 2018

Record last verified: 2018-02

Data Sharing

IPD Sharing
Will share

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

Shared Documents
SAP
Time Frame
when the article is published
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