Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02640963
Other study ID # RO 1823
Secondary ID
Status Completed
Phase N/A
First received December 15, 2015
Last updated December 28, 2015
Start date January 2015
Est. completion date May 2015

Study information

Verified date December 2015
Source Bond University
Contact n/a
Is FDA regulated No
Health authority Australia: Human Research Ethics Committee
Study type Interventional

Clinical Trial Summary

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


Description:

Study Design and Recruitment This study compared the delivery feasibility and outcomes of a 12-week combined resistance and weight bearing exercise programme which the investigators named the GrACE programme. Participant recruitment and assessment occurred over a five-month period.

The RAC was approached about participation via email and telephone follow-up. Potential participants were identified at a meeting with the facility Service Manager. Participants were screened via the inclusion criteria at the meeting with the Service Manager and a Registered Nurse, and written consent was attained prior to participation. Following an explanation of the procedures, purposes, benefits and associated risks of the study, participants had the opportunity to ask questions. A total of 37 older RAC adults provided written informed consent and were randomised into the study. The exercise group contained 20 participants and the control group 17 participants. Ethical approval to conduct this study was attained from Bond University's Human Ethics Research Committee (RO 1823).

Intervention: the GrACE programme Previous work by our group trialled a successful exercise programme in respite day care that could promise benefits to those in RAC (HenwoodWooding & de Souza 2013). In brief, the GrACE programme included a number of targeted 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 programme was slightly modified for the RAC setting; initially using reduced range of motion and resistance, and an extended conditioning/familiarisation phase. The conditioning phase lasted for three weeks in which technique was emphasised without using any weights or additional resistance. The focus of this technique of the conditioning phase was to develop the correct technique and minimise the potential for any delayed onset muscle soreness or adverse effects. After concluding the conditioning phase, participants were able to use light dumbbells (often starting with 0.5kg) increasing to heavier dumbbells (up to 4kg) with their increasing capacity over the course of the programme. 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 allied health professional experienced working with RAC adults.

Control Group 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.

Data Collection Reasons for refusal (non-consent) to participate were recorded (Henwood 2014). All muscle function outcome measures in this study have been previously validated for use with older adults, and their protocols reported elsewhere (Henwood, Wooding & de Souza 2013; Sterke et al. 2012). Assessments were completed one-on-one with each participant. During muscle function measures assessments, participants were encouraged to rest as needed and given verbal support and encouragement to reduce any potential burden to the participant.


Recruitment information / eligibility

Status Completed
Enrollment 37
Est. completion date May 2015
Est. primary completion date May 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 65 Years to 100 Years
Eligibility Inclusion Criteria:

- 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.

Exclusion Criteria:

- 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label


Related Conditions & MeSH terms


Intervention

Other:
Exercise
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.
Control
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

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Bond University

References & Publications (8)

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.

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. — View Citation

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. — View Citation

Mathiowetz V. Comparison of Rolyan and Jamar dynamometers for measuring grip strength. Occup Ther Int. 2002;9(3):201-9. — View Citation

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. — View Citation

Millor N, Lecumberri P, Gómez M, Martínez-Ramírez 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. — View Citation

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. Review. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary recruitment rate defined as the number of residents recruited from those invited. Measurement units = number and percentage up to 12 weeks No
Primary 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 No
Primary 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 No
Primary 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 No
Primary 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 No
Primary 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 No
Secondary Gait Speed Gait speed was 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. The following instructions were given, "Walk towards the end of the room at a pace that is comfortable for you". Participants were allowed to walk in their own footwear. All measures were 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. The average gait speed (m/s) from three attempts was used for data analysis. Participants were allowed as much rest as required between attempts, with rest periods typically being up to 1 minute. Measurement units = metres per second change from baseline to 12 weeks Yes
Secondary Handgrip strength Upper body muscle function was measured by isometric handgrip strength and sit-to-stand performance, respectively. When performing the handgrip strength assessments, participants were seated, instructed to keep their elbow at 90° and asked to squeeze a handgrip dynamometer (Sammons Preston Roylan, Bolingbrook, IL) to their maximum ability for a period of up to five seconds (Mathiowetz 2002). Three trials were performed with the subject's dominant hand with one-minute rest between trials and the best result used for analysis (Roberts 2011). Measurement units = kilograms change from baseline to 12 weeks Yes
Secondary Sit to stand performance In the sit-to-stand measure, participants sat and stood to a full standing position from a chair as many times as possible in 30 seconds whilst keeping their arms crossed against their chest (Millor 2013). Measurement units = repetitions in 30 seconds change from baseline to 12 weeks Yes
See also
  Status Clinical Trial Phase
Active, not recruiting NCT06287502 - Efficacy of Structured Exercise-Nutritional Intervention on Sarcopenia in Patients With Osteoporosis N/A
Recruiting NCT05063279 - RELIEF - Resistance Training for Life N/A
Completed NCT03644030 - Phase Angle, Lean Body Mass Index and Tissue Edema and Immediate Outcome of Cardiac Surgery Patients
Recruiting NCT06143592 - Inspiratory Muscle Training on Balance, Falls and Diaphragm Thickness in the Elderly N/A
Terminated NCT04350762 - Nutritional Supplementation in the Elderly With Weight Loss N/A
Enrolling by invitation NCT05953116 - Managing the Nutritional Needs of Older Filipino With Due Attention to Protein Nutrition and Functional Health Study N/A
Recruiting NCT04028206 - Resistance Exercise or Vibration With HMB for Sarcopenia N/A
Enrolling by invitation NCT03297632 - Improving Muscle Strength, Mass and Physical Function in Older Adults N/A
Completed NCT04015479 - Peanut Protein Supplementation to Augment Muscle Growth and Improve Markers of Muscle Quality and Health in Older Adults N/A
Completed NCT03234920 - Beta-Hydroxy-Beta-Methylbutyrate (HMB) Supplementation After Liver Transplantation N/A
Recruiting NCT03998202 - Myopenia and Mechanisms of Chemotherapy Toxicity in Older Adults With Colorectal Cancer
Recruiting NCT04717869 - Identifying Modifiable PAtient Centered Therapeutics (IMPACT) Frailty
Completed NCT05497687 - Strength-building Lifestyle-integrated Intervention N/A
Completed NCT03119610 - The Physiologic Effects of Intranasal Oxytocin on Sarcopenic Obesity Phase 1/Phase 2
Recruiting NCT05711095 - The Anabolic Properties of Fortified Plant-based Protein in Older People N/A
Recruiting NCT05008770 - Trial in Elderly With Musculoskeletal Problems Due to Underlying Sarcopenia - Faeces to Unravel Gut and Inflammation Translationally
Not yet recruiting NCT05860556 - Sustainable Eating Pattern to Limit Malnutrition in Older Adults
Recruiting NCT04545268 - Prehabilitation for Cardiac Surgery in Patients With Reduced Exercise Tolerance N/A
Recruiting NCT04522609 - Electrostimulation of Skeletal Muscles in Patients Listed for a Heart Transplant N/A
Recruiting NCT03160326 - The QUALITY Vets Project: Muscle Quality and Kidney Disease