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Trial registered on ANZCTR


Registration number
ACTRN12616001044415
Ethics application status
Approved
Date submitted
22/07/2016
Date registered
4/08/2016
Date last updated
11/07/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Effectiveness of a Multicomponent Exercise Program in the Attenuation of Frailty in Long-Term Nursing Frail Elders: A Randomised Clinical Controlled Trial.
Scientific title
Effectiveness of a Multicomponent Exercise Program in the Attenuation of Frailty in Long-Term Nursing Frail Elders: A Randomised Clinical Controlled Trial.
Secondary ID [1] 289732 0
Nil known
Universal Trial Number (UTN)
U1111-1185-6368
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
FRAILTY 299573 0
AGEING 299705 0
Condition category
Condition code
Physical Medicine / Rehabilitation 299643 299643 0 0
Physiotherapy
Other 299644 299644 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Subjects in the intervention group will add to the activities scheduled for the control group, the participation in a multicomponent exercise program designed to improve strength, balance and walking retraining conducted by an experienced physical trainer. The programme´s technical content is based on a specific literature review including authors’ expertise and field experience, and it is divided into two sections of 3 months long. Each section has specific objectives and a standardised framework (combination and sequence of exercises), but the goals are individualized based on each participants’ level of physical fitness. Goals will be adapted in response to illness, injury or physical symptoms. The intervention has been designed to meet the exercise and physical activity guidelines for older adults established by the American College of Sport Medicine (ACSM) and American Heart Association.
The intervention will consist of 45 minute group supervised sessions conducted twice a week where the exercises will be directed to improve strength and balance. An interval of at least 48 hours between training sessions will be respected. All sessions will begin with a brief warm-up of 5 minutes (range-of-motion exercises for the neck, wrists, shoulders, hip, knees and ankles). Strength training (25 minutes) will comprise upper and lower body exercises performed with external weights, which will be tailored to the individual´s functional capacity through Brzycki equation for the estimation of 1-RM (repetition maximum) at baseline and at the end of every month, to ensure an appropriate training stimulus. In all strength tests subjects will be encouraged verbally to perform each exercise as forcefully as possible. In the three first months exercises will be performed with light loads (40-50% 1-RM) to ensure an appropriate adaption to resistance exercise and thereafter loads will be increased to 60-70% 1-RM for additional benefits if well tolerated.
Balance training (10 minutes) will include exercises in progressing difficulty starting by decreasing arm support (with 2 arms at first, with one hand, and finally none if possible) along with decreasing base of support (both feet together, semi-tandem and tandem positions) and increasing complexity of movements as to challenge participants´ balance as they progress. Exercises will be varied through the period: weight transfer from one leg to another, walking with small obstacles, propioceptive exercises and stepping practice. Sessions will finish with 5 minutes of cooling down by stretching, breathing and relaxing exercises.
Walking retraining will be also implemented through individualized recommendations to perform out of the supervised sessions in their own.
Training attendance will be recorded every session.
Intervention code [1] 295369 0
Treatment: Other
Comparator / control treatment
Subjects in the control group will participate in the routine activities all nursing homes usually offer to the attenders: memory workshops, reading, singing, etc. Activities will be low intensity in any case.
Control group
Active

Outcomes
Primary outcome [1] 299021 0
The primary outcome measure will be the difference in function between intervention and control group assessed by changes in summary ordinal score on the Short Physical Performance Battery (SPPB). SPPB consists of three tests: balance, gait ability and leg strength. The score for each test is given in categorical modality (0-4) based on run time intervals, and the total score will range from 0 (worst) to 12 points (best). The SPPB has been shown to be a valid instrument for screening frailty and predicting disability, institutionalization and mortality. A total score of less than 10 points indicates frailty and a high risk of disability and falls. 1 point change in the total score has demonstrated to be of clinical relevance.
Timepoint [1] 299021 0
Study assessments will be conducted by blinded research staff during clinic visits at baseline, as well as at 3 and 6 months from the beginning of the intervention.
Primary outcome [2] 299022 0
Active and sedentary periods during everyday life recorded with an accelerometer (Actigraph GT3X model (Actigraph LLC, Pensacola, FL, USA)) that will be worn on the hip with a belt for a 7 day period. The device will be set to quantify the number of steps taken per day. In line with that, active-period intensities will be classified following the criteria developed by Freedson et al., 1998 as low, medium or high intensity and measured in minutes.
Timepoint [2] 299022 0
Baseline, and at 3 and 6 months from the beginning of the intervention.
Primary outcome [3] 299023 0
Cognitive assesment by Montreal Cognitive Assessment Score. It assesses different cognitive domains: attention and concentration, executive functions, memory, language, visuoconstructional skills, conceptual thinking, calculations, and orientation. The total possible score is 30
points; a score of 26 or above is considered normal.
Timepoint [3] 299023 0
Baseline, 3 and 6 months from the beginning of the intervention.
Secondary outcome [1] 325885 0
Brain Derived Neurotrophic Factor biomarker by serum assay through ELISA kit (ChemiKine TM; Millipore, Temecula, CA) following the manufacturer’s instructions.
Timepoint [1] 325885 0
Baseline, 3 and 6 months from the beginning of the intervention.
Secondary outcome [2] 325886 0
Irisin biomarker by serum assay through ELISA kit (ChemiKine TM; Millipore, Temecula, CA) following the manufacturer’s instructions.
Timepoint [2] 325886 0
Baseline, 3 and 6 months from the beginning of the intervention.
Secondary outcome [3] 325887 0
Quality of life assessed using EuroQoL-5D-5L.
Timepoint [3] 325887 0
Baseline, 3 and 6 months from the beginning of the intervention.
Secondary outcome [4] 325888 0
Visits to the emergency services by review of medical records.
Timepoint [4] 325888 0
3 and 6 months from the beggining of the intervention.

Eligibility
Key inclusion criteria
Subjects will be considered eligible for the study if all of the following apply: aged greater than or equal to 70 years, scored greater than or equal to 50 on the Barthel Index, scored greater than or equal to 20 on MEC-35 Test (an adapted and validated version of MMSE in Spanish) who are all capable to stand up and walk independently for 10 m.
Minimum age
70 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Participants will not be eligible for the study if they are clinically unstable under the clinical judgment of the medical professionals of the reference center, or in any other condition that means that entering the study would not be in the subject´s best interests.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Coin-tossing
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Sample size has been calculated to detect minimal significant effects on the variable of physical performance (SPPB): accepting an alpha risk of 0.05 and a beta risk of 0.20 in a bilateral contrast, 86 individuals are required in order to detect a difference equal to or greater than 1 unit in the SPPB (SD= 2.34). It has been increased the sample size in an additional 20% (losts during follow-up) and 5% (mortality). The resultant sample size is determinate in 114 individuals, therefore 57 individuals per group (intervention and control group).

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 8045 0
Spain
State/province [1] 8045 0
Basque Country

Funding & Sponsors
Funding source category [1] 294117 0
Government body
Name [1] 294117 0
Government of the Basque Country
Address [1] 294117 0
Alameda de Urquijo 36,
Edificio Plaza Bizkaia,
48011 Bilbao
Country [1] 294117 0
Spain
Funding source category [2] 294118 0
University
Name [2] 294118 0
University of the Basque Country
Address [2] 294118 0
Vice-Rectorate of Research
Sarriena, s/n
48940-Leioa (Bizkaia)
Spain
Country [2] 294118 0
Spain
Primary sponsor type
Individual
Name
Jon Irazusta Astiazaran
Address
University of the Basque Country
Department of Physiology
Faculty of Medicine and Nursing
Barrio Sarriena s/n,
48940 Leioa, BI
Country
Spain
Secondary sponsor category [1] 292946 0
None
Name [1] 292946 0
Address [1] 292946 0
Country [1] 292946 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295523 0
CEIAB- University of the Basque Country
Ethics committee address [1] 295523 0
Comite Etico de Investigacion Agentes Biologicos
Barrio Sarriena s/n,
48940 Leioa, BI
Ethics committee country [1] 295523 0
Spain
Date submitted for ethics approval [1] 295523 0
27/04/2016
Approval date [1] 295523 0
21/06/2016
Ethics approval number [1] 295523 0
M30/2016/106
Ethics committee name [2] 295524 0
CEISH
Ethics committee address [2] 295524 0
Comite Etico de Investigacion en Seres Humanos
Barrio Sarriena s/n,
48940 Leioa, BI
Ethics committee country [2] 295524 0
Spain
Date submitted for ethics approval [2] 295524 0
27/04/2016
Approval date [2] 295524 0
09/06/2016
Ethics approval number [2] 295524 0
M10/2016/105

Summary
Brief summary
The major aim of this study is to ascertain if a supervised multicomponent exercise program carried out in long-term nursing care centers improves or maintains functionality, sedentary behaviors, cognitive and emotional status, health related quality of life and modifies biological markers related with frailty when compared with a control population that received usual care.
The present study is based on a previous pilot study in which we successfully collected preliminary data to accurately demonstrate the feasibility of recruitment, estimate the required sample size for the current trial, confirm the adherence and safety of the intervention, refine the outcome assessments, and optimize the organizational infrastructure.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 67614 0
Prof JON IRAZUSTA ASTIAZARAN
Address 67614 0
University of the Basque Country
Physiology Department
Faculty of Medicine and Nursing
Barrio Sarriena s/n,
48940 Leioa, BI
Country 67614 0
Spain
Phone 67614 0
+34 94 6012837
Fax 67614 0
Email 67614 0
jon.irazusta@ehu.eus
Contact person for public queries
Name 67615 0
Prof JON IRAZUSTA ASTIAZARAN
Address 67615 0
University of the Basque Country
Physiology Department
Faculty of Medicine and Nursing
Barrio Sarriena s/n,
48940 Leioa, BI
Country 67615 0
Spain
Phone 67615 0
+34 94 6012837
Fax 67615 0
Email 67615 0
jon.irazusta@ehu.eus
Contact person for scientific queries
Name 67616 0
Dr ANA RODRIGUEZ LARRAD
Address 67616 0
University of the Basque Country
Physiology Department
Faculty of Medicine and Nursing
Barrio Sarriena s/n,
48940 Leioa, BI
Country 67616 0
Spain
Phone 67616 0
+34 94 6017925
Fax 67616 0
Email 67616 0
ana.rodriguez@ehu.eus

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary