NCT02766738

Brief Summary

This study aims to test which of three exercise programs, previously demonstrated valuable for residential aged care adults, has the greatest benefit for walking speed and the spatiotemporal parameters that define it. The programs to be included are:

  1. 1.The GrACE program and
  2. 2.The GrACE plus Gait specific training.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
84

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2016

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

May 1, 2016

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

May 6, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 10, 2016

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
Last Updated

May 8, 2017

Status Verified

May 1, 2017

Enrollment Period

7 months

First QC Date

May 6, 2016

Last Update Submit

May 4, 2017

Conditions

Keywords

residential aged caremobilitysocial participationfunctional capability

Outcome Measures

Primary Outcomes (1)

  • Gait speed and spatio-temporal parameters (in a wider variety of walking tasks)

    Gait speed and spatio-temporal parameters will be recorded via the GaitMat II system (Manufacturer is EQInc; Model is GaitMat II), which required participants to walk across a level pressure mat system 3.66 m (11.91 ft.) long (McDonough et al. 2001). Participants completed the trials at their preferred (habitual) walking (gait) speed. All measures will be initiated from a standing start 2 m (6.56 ft.) from the GaitMat II platform as suggested by Kressig and Beauchet (Kressig \& Beauchet 2006) to reduce the effect that acceleration may have on gait speed. Three conditions will be measured which include normal walking, along with two dual tasks. These dual tasks include: (i) walking while carrying a glass of water in the participants preferred hand, (ii) walking while counting backwards from 30. Each of these gait conditions will be performed for three repetitions in a randomised block order (Taylor, 2012).

    change from baseline to 24 weeks

Secondary Outcomes (5)

  • Sit to stand performance

    change from baseline to 24 weeks

  • handgrip strength

    change from baseline to 24 weeks

  • Body Composition

    change from baseline to 24 weeks

  • Quality of Life (EQ-5D-EL)

    change from baseline to 24 weeks

  • Sarcopenia status (SARC-F)

    change from baseline to 24 weeks

Study Arms (3)

Control

NO INTERVENTION

All participants assigned to the control group will be given the option to engage in other activities that were offered by the facility during the 24-week intervention period. However, no specific resistance exercises were offered in these activities.

GrACE program

EXPERIMENTAL

Participants in the exercise group will perform twice weekly training for 24 weeks. In brief, the program will include weight-bearing exercises and a range of seated, non-resisted upper- and lower-body dynamic and reaching movements. The following-weight bearing and resistance exercises: chair stands, chair dips, calf raises and hip flexor/abdominal lifts, trunk twists, and bicep curl and shoulder press. In total the sessions will be 45 minutes twice weekly.

Other: GrACE program

GrACE + gait program

EXPERIMENTAL

GrACE program as mentioned above plus focus on gait specific training will be one-hour training sessions for 24 weeks. Gait exercises will be a combination of exercises: heel and toe raises, stepping in different directions, single leg stand¬ing, step-ups, and task-specific balance work (e.g. reaching outward from the base of support while standing, sitting, and standing and turning). Gait exercises will be upgraded by: 1) reducing hand support and/or 2) narrowing the base of support, and/or 3) introducing a cognitive challenge (e.g. counting backwards while performing exercise) or perform¬ing exercise with the eyes closed.

Other: GrACE + gait

Interventions

to compare with the GrACE + gait programme in RAC, as well as the secondary objective of measuring the programme benefits on gait speed, sit to stand and handgrip strength against the intervention and control group

GrACE program

to compare with the GrACE programme in RAC, as well as the secondary objective of measuring the programme benefits on gait speed, sit to stand and handgrip strength against the intervention and control group

GrACE + gait program

Eligibility Criteria

Age65 Years - 100 Years
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • aged over 65 years
  • residing in a RAC facility
  • able to walk with a walker and/or walking stick or can self-ambulate for the test (including those who have had knee and hip replacements)
  • can provide informed consent (Self- or by proxy).

You may not qualify if:

  • end-stage terminal and/or life expectancy \<6-months (ethical reasons)
  • two person transfer or unable to self-ambulate (increased falls risk)
  • unable to communicate or follow instructions (personal needs beyond the scope of this project)
  • dangerous behaviours (endanger the client or research staff).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Darlington RSL Care

Tweed Heads, New South Wales, 2486, Australia

Location

Related Publications (7)

  • Mathiowetz V. Comparison of Rolyan and Jamar dynamometers for measuring grip strength. Occup Ther Int. 2002;9(3):201-9. doi: 10.1002/oti.165.

  • McDonough AL, Batavia M, Chen FC, Kwon S, Ziai J. The validity and reliability of the GAITRite system's measurements: A preliminary evaluation. Arch Phys Med Rehabil. 2001 Mar;82(3):419-25. doi: 10.1053/apmr.2001.19778.

  • Kressig RW, Beauchet O; European GAITRite Network Group. Guidelines for clinical applications of spatio-temporal gait analysis in older adults. Aging Clin Exp Res. 2006 Apr;18(2):174-6. doi: 10.1007/BF03327437.

  • Roberts HC, Denison HJ, Martin HJ, Patel HP, Syddall H, Cooper C, Sayer AA. A review of the measurement of grip strength in clinical and epidemiological studies: towards a standardised approach. Age Ageing. 2011 Jul;40(4):423-9. doi: 10.1093/ageing/afr051. Epub 2011 May 30.

  • Millor N, Lecumberri P, Gomez M, Martinez-Ramirez A, Izquierdo M. An evaluation of the 30-s chair stand test in older adults: frailty detection based on kinematic parameters from a single inertial unit. J Neuroeng Rehabil. 2013 Aug 1;10:86. doi: 10.1186/1743-0003-10-86.

  • Taylor ME, Delbaere K, Mikolaizak AS, Lord SR, Close JC. Gait parameter risk factors for falls under simple and dual task conditions in cognitively impaired older people. Gait Posture. 2013 Jan;37(1):126-30. doi: 10.1016/j.gaitpost.2012.06.024. Epub 2012 Jul 23.

  • Hewitt J, Refshauge KM, Goodall S, Henwood T, Clemson L. Does progressive resistance and balance exercise reduce falls in residential aged care? Randomized controlled trial protocol for the SUNBEAM program. Clin Interv Aging. 2014 Feb 21;9:369-76. doi: 10.2147/CIA.S53931. eCollection 2014.

MeSH Terms

Interventions

Gait

Intervention Hierarchy (Ancestors)

Physical ExaminationDiagnostic Techniques and ProceduresDiagnosisWalkingLocomotionMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Justin Keogh, PhD

    Bond University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD Student

Study Record Dates

First Submitted

May 6, 2016

First Posted

May 10, 2016

Study Start

May 1, 2016

Primary Completion

December 1, 2016

Study Completion

January 1, 2017

Last Updated

May 8, 2017

Record last verified: 2017-05

Data Sharing

IPD Sharing
Will not share

Locations