NCT02555033

Brief Summary

Aging results in a gradual decline of physical abilities and consequently in functional impairments which increases the risk of falls in elderly people. It has been shown, that balance and resistance training can counteract the effects of aging. The aim of this study was to investigate effects of instability resistance training (IRT), combining balance and resistance training, on measures of muscle strength / power and balance for falls in healthy community-dwelling older adults. Therefore 75 elderly people, aged 65 - 80 years (Mage = 70.4; SD = 4.3 years) were assigned into three intervention groups: machine-based (M-RT), machine-based instability (M-IRT), free weight instability resistance training (F-IRT). All three groups exercised over 10-weeks with two training sessions per week. Assessment of muscle strength (e.g. maximal isometric leg extension strength), power (e.g. chair rise test) and balance (e.g. gait, functional reach test) was conducted before and after training. Based on the principle of training specificity, it is assumed, that groups to improve better within their respective training modality. Thus, the investigators hypothesis that regarding measures of strength and power, M-RT performs better than M-IRT, performs better than F-IRT. As to measures of balance, we hypothesis that F-IRT performs better that M-IRT, performs better than M-RT.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
75

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2014

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

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

February 1, 2014

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

September 8, 2015

Completed
13 days until next milestone

First Posted

Study publicly available on registry

September 21, 2015

Completed
Last Updated

September 21, 2015

Status Verified

September 1, 2015

Enrollment Period

7 months

First QC Date

September 8, 2015

Last Update Submit

September 18, 2015

Conditions

Keywords

Instability resistance trainingunstable surfaceelderly people

Outcome Measures

Primary Outcomes (1)

  • Maximal isometric leg extension strength (ILES)

    change in isometric strength, measured in N

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

Secondary Outcomes (10)

  • Fall self-efficacy Questionnaire

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

  • Dynamic Balance (stride velocity)

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

  • Dynamic Balance (stride length & step width)

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

  • Dynamic Balance (double support)

    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)

  • +5 more secondary outcomes

Study Arms (3)

M-RT

EXPERIMENTAL

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

Other: Resistance training

M-IRT

EXPERIMENTAL

Machine-based instability resistance training; a similar training program with exercise-machines, but with additional unstable devices placed between participant and exercise-machine or floor respectively.

Other: Instability resistance training

F-IRT

EXPERIMENTAL

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

Other: Instability resistance training

Interventions

traditional resistance training

M-RT

training under unstable conditions

F-IRTM-IRT

Eligibility Criteria

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

You may qualify if:

  • 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

Study Sites (1)

University of Kassel

Kassel, Hesse, 34132, Germany

Location

Related Publications (3)

  • Gschwind YJ, Kressig RW, Lacroix A, Muehlbauer T, Pfenninger B, Granacher U. A best practice fall prevention exercise program to improve balance, strength / power, and psychosocial health in older adults: study protocol for a randomized controlled trial. BMC Geriatr. 2013 Oct 9;13:105. doi: 10.1186/1471-2318-13-105.

  • Behm D, Colado JC. The effectiveness of resistance training using unstable surfaces and devices for rehabilitation. Int J Sports Phys Ther. 2012 Apr;7(2):226-41.

  • 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.

MeSH Terms

Conditions

Muscle Weakness

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesPathologic ProcessesPathological 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

  • Armin Kibele, Prof., PhD

    University of Kassel

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MEd

Study Record Dates

First Submitted

September 8, 2015

First Posted

September 21, 2015

Study Start

February 1, 2014

Primary Completion

September 1, 2014

Study Completion

September 1, 2014

Last Updated

September 21, 2015

Record last verified: 2015-09

Locations