Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000536268
Ethics application status
Approved
Date submitted
7/02/2018
Date registered
11/04/2018
Date last updated
23/04/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Effects of a dual task vs. multicomponent exercise program in long-term nursing home residents
Scientific title
Effectiveness of a Dual-Task multicomponent exercise program on frailty in long-term nursing home residents: The Aging-OnDT project
Secondary ID [1] 293108 0
None
Universal Trial Number (UTN)
U1111-1203-5586
Trial acronym
Aging-OnDT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
frailty
 305054 0
aging 305055 0
Condition category
Condition code
Physical Medicine / Rehabilitation 304373 304373 0 0
Physiotherapy
Public Health 304374 304374 0 0
Health promotion/education
Musculoskeletal 305814 305814 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Subjects in both the Control and the Intervention group will undertake a multicomponent exercise program that has previously been described regarding the volume, intensity, type and duration of the exercises by the present research group (Rodriguez-Larrad et al., 2017). Moreover, the feasibility, safety and beneficial effects on long-term nursing home residents have also been published (Arrieta et al., 2018).
Subjects will participate in a multicomponent exercise program designed to improve strength and balance conducted by an experienced physical trainer. The programme´s technical content is based on a specific literature review including authors’ expertise and field experience. It 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 first month 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.
The intervention will be performed in groups of 5-8 participants, in the facilities of their nursing-home
Training attendance will be recorded by the physical trainer every session.
Additionally, subjects of the Intervention group will perform cognitive tasks simultaneously to the physical exercises, this attention-demanding physical performance carrying out two tasks (physical + cognitive) at the same time are known as Dual Task (DT).
In the DT training, during the multicomponent exercises, concurrent individually tailored cognitive tasks relying predominantly on executive function will be applied to the physical training. Challenge of DT-s will be increased by augmenting complexity of motor tasks (progressing from sitting to standing and from static to dynamic exercises, reducing base of support, etc) and/or cognitive tasks (number of stimulus, complexity of word categories, etc).
The first week of the intervention will mainly serve to familiarize participants with the strength and balance exercises and adequate the level of difficulty of each cognitive function to every participant in the group. Thereafter on the second week, strength tests will be performed to individualize strength training and ensure training intensity. Throughout the following weeks dual tasking will be applied mostly in strength exercises to train for divided attention allocation and progressively move to balance exercises to optimize training adaptations and mimic everyday situations that require double tasking and increasing instability.
Cognitive training will be conducted based on six main cognitive essential functions for everyday life activities:
1) One of the most important functions to train is attention, which will be applied in form of: a) divided attention tasks (DAT) (both with a secondary physical or a cognitive task) where participants will have to divide their attention to ensure task achievement; b) sustained attention tasks (SAT), in which attention will have to be maintained throughout a certain time period (1-2 minutes); c) shifting, where participants will have to shift their attention just like in everyday situations.
2) In addition, semantic fluency will consist of naming words according to different categories with increasing difficulty such as naming animals, professions or even dog breeds.
3 and 4) Other executive functions including calculus or inhibitory control will also be trained, the latter consisting of overriding the natural response after certain stimulus.
5 and 6) Finally, due to the fact that movement coordination as well as movement learning and sequencing are inherent to any exercise-based program, these will be present in both multicomponent and dual task groups.


Bibliography:
Rodriguez-Larrad A, Arrieta H, Rezola C, Kortajarena M, Yanguas JJ, Iturburu M, Susana MG, Irazusta J. Effectiveness of a multicomponent exercise program in the attenuation of frailty in long-term nursing home residents: study protocol for a randomized clinical controlled trial. BMC Geriatr. 2017;17(1):60. doi: 10.1186/s12877-017-0453-0.
Arrieta H, Rezola-Pardo C, Zarrazquin I, Echeverria I, Yanguas JJ, Iturburu M, Gil SM, Rodriguez-Larrad A, Irazusta J. A multicomponent exercise program improves physical function in long-term nursing home residents: A randomized controlled trial. Exp Gerontol. 2018;103:94-100. doi: 10.1016/j.exger.2018.01.008.
Intervention code [1] 299352 0
Treatment: Other
Comparator / control treatment
The Control Group will attend a twice-a-week multicomponent exercise training of 45' minute duration per session, consisting of strength and balance exercises conducted by an experienced physical trainer. Participants will also continue attending their usual activities and workshops.
The intervention has been described above
Control group
Active

Outcomes
Primary outcome [1] 303625 0
The primary outcome measure will be gait speed under DT condition.
Gait speed is the usual walking pace of the participant. To measure it, the time needed to walk 9 meters is recorded using a stop-watch, afterwards the speed (m/s) is calculated. On this ocassion the gait speed as a single task and a gait speed while undertaking a cognitive task (Dual Task) will be performed.
Timepoint [1] 303625 0
Measurements will be conducted by blinded research staff at baseline and after the intervention (3 months).
Primary outcome [2] 304711 0
Gait spatiotemporal parameters measured using the G-walk such as cadence, single and double support time, speed, step length
Timepoint [2] 304711 0
Measurements will be made at baseline and after the intervention (3 months)
Primary outcome [3] 304712 0
The time difference between a single task (gait speed, only walking) and a dual task (gait speed while walking and undertaking a cognitive task). The difference is known as the Dual Task Cost
Timepoint [3] 304712 0
Measurements will be made at baseline and after the intervention (3 months)
Secondary outcome [1] 339683 0
The Short Physical Performance Battery test (SPPB). It assesses Lower extremity function: static balance, gait speed and getting in and out of a chair. The participant undertakes different tests: Side-by-side, semi-tandem and tandem stands (10 seconds); 4 meters walk test at comfortable speed and 5 quickly sit to stand from a chair without upper extremity assistance.

Reference:
Guralnik et al, 1994. A short physical performance battery assessing lower extremity function: association with self-reported disability and prediction of mortality and nursing home admission. J Gerontol. 1994; 49(2):M85-94. doi: 10.1093/geronj/49.2.M85.
Timepoint [1] 339683 0
Measurements will be made at baseline and after the intervention (3 months)
Secondary outcome [2] 342903 0
Upper strength of the Senior Fitness test. Performed test: number of arm curls performed in 30 seconds

Reference:
Rikli & Jones, 2007. Senior fitness test. Human Kinetics, Champaign; 2001. ISBN 0-7360-3356-4.
Timepoint [2] 342903 0
Measurements will be made at baseline and after the intervention (3 months)
Secondary outcome [3] 342904 0
The instrumented Timed Up and Go test, using a BTS Biomedical G-WALK triaxial accelerometer and gyroscope, to measure dynamic balance. The participant gets up from a chair, walks 3 meters at a normal pace, turns and walks back to sit down again

Reference:
Mathias et al, 1986. Balance in elderly patients: the "get-up and go" test. Arch Phys Med Rehabil. 1986; 67(6):387-9.
Timepoint [3] 342904 0
Measurements will be made at baseline and after the intervention (3 months)
Secondary outcome [4] 342907 0
The usual walking speed. The participant will wear a G-walk instrument (BTS Biomedical G-WALK)

Reference:
Bohannon et al, 1996. Walking speed: reference values and correlates for older adults. J Orthop Sports Phys Ther. 1996; 24(2):86-90. doi: 10.2519/jospt.1996.24.2.86.
Timepoint [4] 342907 0
Measurements will be made at baseline and after the intervention (3 months)
Secondary outcome [5] 342910 0
The handgrip strength test. For that the participant squeezes the dynamometer with maximum isometric effort for about 5 seconds.


Reference:
Fess, 1992. Clinical assessment recommendations. 2. Casanova JS, editor. Chicago: American Society of Hand Therapists; 1992. Grip strength; pp. 41–45.
Timepoint [5] 342910 0
Measurements will be made at baseline and after the intervention (3 months)
Secondary outcome [6] 342911 0
Berg balance test to estimate postural stability.

Reference:
Berg et al, 1992. Measuring balance in the elderly: validation of an instrument. Can J Publ Health. 1992; 83:S7-11
Timepoint [6] 342911 0
Measurements will be undertaken at baseline and after the intervention (3 months)
Secondary outcome [7] 342912 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.

Reference:
Freedson et al, 1988. Calibration of the Computer Science and Applications, Inc. accelerometer. Med Sci Sports Exerc. 1998; 30(5):777-81. doi: 10.1097/00005768-199805000-00021.
Timepoint [7] 342912 0
Measurements will be undertaken at baseline and after the intervention (3 months)
Secondary outcome [8] 342913 0
Montreal Cognitive Assessment (MoCA). It assesses different cognitive domains: attention and concentration, executive functions, memory, language, constructional skills, conceptual thinking, calculations, and orientation. The total possible score is 30 points; a score of 26 or above is considered normal.

Reference:
Coen et al, 2016.Strengths and Limitations of the MoCA for Assessing Cognitive Functioning Findings From a Large Representative Sample of Irish Older Adults. Journal of Geriatric Psychiatry and Neurology. 2016; 29(1):18-24. doi: 10.1177/0891988715598236.
Timepoint [8] 342913 0
Measurements will be undertaken at baseline and after the intervention (3 months)
Secondary outcome [9] 342914 0
Symbol Digit Modalities Test (SDMT). It measures Cognitive impairment. Covered domains: Attention, Visual Scanning, Motor Speed.

Reference:
Sheridan et al, 2006. Normative Symbol Digit Modalities Test performance in a community-based sample. Arch Clin Neuropsychol. 2006; 21(1):23-8. doi:10.1016/j.acn.2005.07.003.
Timepoint [9] 342914 0
Measurements will be undertaken at baseline and after the intervention (3 months)
Secondary outcome [10] 342915 0
Trail making Test (TMT). it measures cognitive impairment. It assesses: visual-conceptual and visual-motor tracking, sustained attention and task alternation abilities.

Reference:
Reitan, 1958. Validity of the Trail Making Test as an Indicator of Organic Brain Damage. Perceptual and Motor Skills, Vol 8, Issue 3, pp. 271 - 276. https://doi.org/10.2466/pms.1958.8.3.271
Timepoint [10] 342915 0
Measurements will be undertaken at baseline and after the intervention (3 months)
Secondary outcome [11] 342916 0
Rey Auditory Verbal Learning Test. It measures learning capacity. Evaluates short- and long-term verbal learning assessing the ability to learn a list of 15 common words.

Reference:
Lezak MD, Howieson DB, Loring DW. Neuropsychological Assessment. 4th ed. New York: Oxford University Press; 2004
Timepoint [11] 342916 0
Measurements will be undertaken at baseline and after the intervention (3 months)
Secondary outcome [12] 342917 0
To assess the affective state the Anxiety and Depression Goldberg Scale will be used. This questionnaire includes nine depression and nine anxiety items from the past month.

Reference:
Goldberg et al, 1988. Detecting anxiety and depression in general medical settings. Br Med J. 1988; 297(6653):897-9. doi:10.1136/bmj.297.6653.897.
Timepoint [12] 342917 0
Measurements will be undertaken at baseline and after the intervention (3 months)
Secondary outcome [13] 342918 0
To assess loneliness The Jong Gierveld loneliness scale will be performed. This questionnaire includes characteristics of the social network, background variables, personality characteristics, and evaluative aspects.

Reference:
De Jong Gierveld, J. (1987). Developing and testing a model of loneliness. Journal of Personality and Social Psychology, 53(1), 119-128.
Timepoint [13] 342918 0
Measurements will be undertaken at baseline and after the intervention (3 months)
Secondary outcome [14] 342919 0
The perceived quality of life will be measured using the Questionnaire QoL-AD. Self-rated quality of life for people with cognitive impairments.

Reference:
Logsdon et al., 2002. Assessing quality of life in older adults with cognitive impairment. Psychosomatic Medicine. 2002;64:510–519.
Timepoint [14] 342919 0
Measurements will be undertaken at baseline and after the intervention (3 months)
Secondary outcome [15] 342921 0
Anthropometric measurements: waist-to-hip ratio will be calculated acording to the waist and hip diameter
Timepoint [15] 342921 0
Measurements will be undertaken at baseline and after the intervention (3 months)
Secondary outcome [16] 342922 0
Frailty will be estimated using the Tilburg Frailty index and also Fried's Frailty index.

References:
Gobbens et al., 2010. The Tilburg Frailty Indicator: psychometric properties. J Am Med Dir Assoc. 11(5):344-55. doi:10.1016/j.jamda.2009.11.003.

Fried et al., 2001. Frailty in older adults: evidence for a phenotype. J Gerontol A Biol Sci Med Sci. 56(3):M146-56. doi: 10.1093/gerona/56.3.M146.
Timepoint [16] 342922 0
Measurements will be undertaken at baseline and after the intervention (3 months)
Secondary outcome [17] 342923 0
Number of falls will be recorded from the medical records
Timepoint [17] 342923 0
Record from the last year and during the intervention will be recorded
Secondary outcome [18] 343451 0
Lower extremity strength of The Senior Fitness test. Performed test: number of Chair-stands performed in 30 seconds

Reference:
Rikli & Jones, 2007. Senior fitness test. Human Kinetics, Champaign; 2001. ISBN 0-7360-3356-4.
Timepoint [18] 343451 0
Measurements will be made at baseline and after the intervention (3 months)
Secondary outcome [19] 343452 0
Flexibility (The Senior Fitness test). Performed test: chair sit and reach

Reference:
Rikli & Jones, 2007. Senior fitness test. Human Kinetics, Champaign; 2001. ISBN 0-7360-3356-4.
Timepoint [19] 343452 0
Measurements will be made at baseline and after the intervention (3 months)
Secondary outcome [20] 343453 0
Dynamic balance of The Senior Fitness test. Performed test: 8 Foot Up and Go test

Reference:
Rikli & Jones, 2007. Senior fitness test. Human Kinetics, Champaign; 2001. ISBN 0-7360-3356-4.
Timepoint [20] 343453 0
Measurements will be made at baseline and after the intervention (3 months)
Secondary outcome [21] 343454 0
Aerobic capacity (The Senior Fitness test). Performed test: 6-minutes walking test

Reference:
Rikli & Jones, 2007. Senior fitness test. Human Kinetics, Champaign; 2001. ISBN 0-7360-3356-4.
Timepoint [21] 343454 0
Measurements will be made at baseline and after the intervention (3 months)
Secondary outcome [22] 343455 0
Number of deaths will be recorded
Timepoint [22] 343455 0
They will be recorded during the intervention

Eligibility
Key inclusion criteria
Residents of a long-term nursing home; age greater than or equal to 70 years; a Barthel Index (Wade and Collin, 1988) score greater than or equal to 50 and score greater than or equal to 20 on the MEC-35 Test (Lobo et al., 1999) [Mini-examen cognoscitivo, an adapted and validated version of Mini Mental State Examination (MMSE) in Spanish]; and capacity to stand up and walk independently for at least 10 metres.

Lobo A, Saz P, Marcos G, Díaz J.L, de la Camara C, Ventura T, Morales Asín F, Fernando Pascual L, Montañes J.A, Aznar S. Revalidación y normali-zación del Mini-Examen Cognoscitivo (primera versión en castellano del Mini-Mental Status Exa-
mination) en la población general geriátrica. Med Clin (Barc). 1999; 112; 767-774
[12] Wade D.T., Collin C. The Barthel ADL Index: a standard measure of physical disability? Int Disabil Stud. 1988; 10(2):64-7. doi: 10.3109/09638288809164105.
Minimum age
70 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Participants will not be eligible if under the clinical judgment of the medical staff are clinically unstable, 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 for the current study has been calculated to detect a significant clinical difference on the DT-gait speed test (Perera et al., 2006): accepting an alpha risk of 0.05 and a beta risk of 0.20 in a bilateral contrast, 184 individuals are required in order to detect a difference equal to or greater than 0.08 m/seg in the DT-gait speed test (SD=0.24). The sample size has been increased by 20% to account for losses during follow up and an additional 5% for mortality. The resulting sample size is of 184 individuals, allocating 92 participants to each group.

Data analysis will be performed using the IBM SPSS Statistics 24 statistical software package (SPSS, Inc., Chicago, IL). Intention to treat analyses will be performed and level of statistical significance will be set at p < .05 for all computations. First of all, all data will be checked for normality of distribution using the Kolmogorov-Smirnov test. Results will be expressed as mean (SD with continuous and normally distributed variables and as median (IQR) when normality of data for that variable cannot be assumed. In the case of categorical variables, frequency counts and percentages will be used to describe the results. Baseline comparisons will be made using different tests based on the nature and distribution of the data: student-t test with continuous and normally distributed variables, Mann Whitney test with non-normally continuous variables and Chi-squared test with categorical ones.
In order to test our hypothesis of the effects of training interventions, mixed-designed ANOVA-s or Friedman test will be performed for physical, cognitive and emotional variables. In cases where a significant F value is found, LSD post hoc procedures will be performed for pairwise comparisons. In addition, to verify whether the two groups differ, an analysis of covariance (ANCOVA) will be performed including baseline measurements, age or gender and other variables as co-variables.

Perera S, Mody SH, Woodman RC, Studenski SA. J Am Geriatr Soc. 2006 May;54(5):743-9.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
30/04/2018
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
184
Accrual to date
Final
Recruitment outside Australia
Country [1] 9278 0
Spain
State/province [1] 9278 0
Gipuzkoa

Funding & Sponsors
Funding source category [1] 297737 0
Government body
Name [1] 297737 0
Basque Goverment
Country [1] 297737 0
Spain
Funding source category [2] 297738 0
University
Name [2] 297738 0
University of the Basque Country (UPV/EHU)
Country [2] 297738 0
Spain
Primary sponsor type
Individual
Name
Susana Gil
Address
University of The Basque Country (UPV/EHU)
Department of Physiology
Faculty of Medicine and Nursing
Barrio Sarriena s/n
Leioa 48940
Bizkaia
Country
Spain
Secondary sponsor category [1] 296771 0
None
Name [1] 296771 0
Address [1] 296771 0
Country [1] 296771 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298800 0
CEIAB- University of the Basque Country
Ethics committee address [1] 298800 0
Ethics committee country [1] 298800 0
Spain
Date submitted for ethics approval [1] 298800 0
Approval date [1] 298800 0
03/10/2017
Ethics approval number [1] 298800 0
Ethics committee name [2] 298801 0
CEISH
Ethics committee address [2] 298801 0
Ethics committee country [2] 298801 0
Spain
Date submitted for ethics approval [2] 298801 0
Approval date [2] 298801 0
03/10/2017
Ethics approval number [2] 298801 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 78266 0
Dr Jon Irazusta
Address 78266 0
University of the Basque Country (UPV/EHU)
Physiology Department
Faculty of Medicine and Nursing
Barrio Sarriena s/n,
48940 Leioa,
Country 78266 0
Spain
Phone 78266 0
+34 94 601 2837
Fax 78266 0
Email 78266 0
[email protected]
Contact person for public queries
Name 78267 0
Susana Gil
Address 78267 0
University of the Basque Country (UPV/EHU)
Physiology Department
Faculty of Medicine and Nursing
Barrio Sarriena s/n,
48940 Leioa,
Country 78267 0
Spain
Phone 78267 0
+34 94 601 2958
Fax 78267 0
Email 78267 0
[email protected]
Contact person for scientific queries
Name 78268 0
Susana Gil
Address 78268 0
University of the Basque Country (UPV/EHU)
Physiology Department
Faculty of Medicine and Nursing
Barrio Sarriena s/n,
48940 Leioa,
Country 78268 0
Spain
Phone 78268 0
+34 946012958
Fax 78268 0
Email 78268 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseA randomized controlled trial protocol to test the efficacy of a dual-task multicomponent exercise program in the attenuation of frailty in long-term nursing home residents: Aging-ONDUAL-TASK study.2019https://dx.doi.org/10.1186/s12877-018-1020-z
EmbasePhysical exercise interventions have no effect on serum BDNF concentration in older adults living in long-term nursing homes.2020https://dx.doi.org/10.1016/j.exger.2020.111024
Dimensions AISerum Sestrin-1 Concentration Is Higher in Frail than Non-Frail Older People Living in Nursing Homes2022https://doi.org/10.3390/ijerph19031079
N.B. These documents automatically identified may not have been verified by the study sponsor.