NCT02640963

Brief Summary

This study is a pilot study (feasibility and acceptability study), which will compare feasibility and efficacy outcomes between a 12-week Exercise Program and control group in RAC residents.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
37

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2015

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, 2015

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

December 15, 2015

Completed
14 days until next milestone

First Posted

Study publicly available on registry

December 29, 2015

Completed
Last Updated

March 21, 2016

Status Verified

March 1, 2016

Enrollment Period

4 months

First QC Date

December 15, 2015

Last Update Submit

March 18, 2016

Conditions

Keywords

exerciseolder adultsphysical performance

Outcome Measures

Primary Outcomes (6)

  • recruitment rate

    defined as the number of residents recruited from those invited. Measurement units = number and percentage

    up to 12 weeks

  • measurement (physiological and surveys) completion rate

    defined as the number of participants able to complete each outcome measure at baseline and follow-up. Measurement units = number and percentage

    up to 12 weeks

  • loss-to-follow-up

    defined as participants who withdrew or dropped out and did not consent to a follow up assessment. Measurement units = number and percentage

    up to 12 weeks

  • exercise session adherence

    measured by the number of sessions attended out of the maximum 24 sessions. Measurement units = number and percentage

    up to 12 weeks

  • acceptability

    measured via a programme satisfaction survey completed post-training that assessed the burden of training and testing, as well as how participants felt about the trial. Measurement units = number and percentage

    up to 12 weeks

  • adverse events

    defined as incidents in which harm or damage resulted to a participant and included, but were not limited to, falls and fall-related injuries, musculoskeletal or cardiovascular incidents and problems with medication and medical devices. Measurement units = number and percentage

    up to 12 weeks

Secondary Outcomes (3)

  • Gait Speed

    change from baseline to 12 weeks

  • Handgrip strength

    change from baseline to 12 weeks

  • Sit to stand performance

    change from baseline to 12 weeks

Study Arms (2)

Intervention: the GrACE programme

EXPERIMENTAL

The programme included several weight-bearing exercises (using body weight and dumbbells) and a range of seated, non-resisted upper- and lower-body dynamic and reaching movements. While developed for respite care older adults, the GrACE programme was slightly modified for the RAC setting; using reduced range of motion and resistance, and an extended conditioning/familiarisation phase. The conditioning phase lasted for three weeks and focus on the development of correct technique. After concluding the conditioning phase, participants started to use light dumbbells. Participants performed the exercises twice per week for 12 weeks. Training sessions lasted approximately 45 minutes, were separated by at least 48 hours and were delivered by an experienced allied health professional.

Other: Exercise

Control Group

PLACEBO COMPARATOR

All subjects assigned to the control group were given the option to engage in other activities that were offered by the facility during the 12-week intervention period. Activities were facility specific, and included Zumba aerobic exercise and walking, however no specific resistance exercises were offered.

Other: Control

Interventions

to determine the feasibility of the GrACE (Group Aged Care Exercise) programme in RAC, with the secondary objective of measuring the programme benefits on gait speed, sit to stand and handgrip strength.

Intervention: the GrACE programme
ControlOTHER

to compare with the GrACE (Group Aged Care Exercise) 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 group

Control Group

Eligibility Criteria

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

You may qualify if:

  • Aged 65 years and over,
  • Residing in a RAC,
  • Able to walk with a walker and/or walking stick or could self-ambulate and,
  • Could provide informed consent.

You may not qualify if:

  • End-stage terminal and/or life expectancy \<6-months (ethical reasons),
  • Two person transfer or unable to self-ambulate (due to increased falls risk),
  • Unable to communicate or follow instructions (personal needs beyond the scope of this project),
  • Insufficient cognitive function to provide informed consent and,
  • Dangerous behaviours that would endanger the client or research staff.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (8)

  • Henwood TR, Keogh JW, Reid N, Jordan W, Senior HE. Erratum to: Assessing sarcopenic prevalence and risk factors in residential aged care: methodology and feasibility. J Cachexia Sarcopenia Muscle. 2014 Sep;5(3):237. doi: 10.1007/s13539-014-0151-0. No abstract available.

    PMID: 24898356BACKGROUND
  • 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.

    PMID: 11245768BACKGROUND
  • Sterke CS, van Beeck EF, Looman CW, Kressig RW, van der Cammen TJ. An electronic walkway can predict short-term fall risk in nursing home residents with dementia. Gait Posture. 2012 May;36(1):95-101. doi: 10.1016/j.gaitpost.2012.01.012. Epub 2012 Mar 3.

    PMID: 22386897BACKGROUND
  • 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.

    PMID: 16702791BACKGROUND
  • 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.

    PMID: 12374997BACKGROUND
  • 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.

    PMID: 21624928BACKGROUND
  • 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.

    PMID: 24059755BACKGROUND
  • Henwood T, Wooding A, and de Souza D. 2013. Centre-based exercise delivery: feasability of a staff-delivered program and the benefits for low-functioning older adults accessing respite day care. Activities, Adaptations & Ageing 73:224-238.

    BACKGROUND

MeSH Terms

Conditions

SarcopeniaMotor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Justin Keogh, PhD

    Bond University

    STUDY CHAIR

Study Design

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

Study Record Dates

First Submitted

December 15, 2015

First Posted

December 29, 2015

Study Start

January 1, 2015

Primary Completion

May 1, 2015

Study Completion

May 1, 2015

Last Updated

March 21, 2016

Record last verified: 2016-03

Data Sharing

IPD Sharing
Will not share