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Trial registered on ANZCTR


Registration number
ACTRN12618000872235
Ethics application status
Approved
Date submitted
17/05/2018
Date registered
22/05/2018
Date last updated
22/05/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Influence of a program of geriatric revitalization as a physical activity on bone mineral density and the risk of falls in people with Alzheimer's disease
Scientific title
Influence of a program of geriatric revitalization, during 6 months, as a physical activity, on bone mineral density and the risk of falls in people with Alzheimer's disease
Secondary ID [1] 294831 0
Nil known
Universal Trial Number (UTN)
U1111-1213-7042
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Alzheimer Disease 307774 0
Falls 307775 0
Bone mineral density 307776 0
Gait 307777 0
Balance 307778 0
Condition category
Condition code
Injuries and Accidents 306818 306818 0 0
Other injuries and accidents
Musculoskeletal 306819 306819 0 0
Osteoporosis
Physical Medicine / Rehabilitation 306821 306821 0 0
Other physical medicine / rehabilitation
Neurological 306822 306822 0 0
Alzheimer's disease
Physical Medicine / Rehabilitation 306947 306947 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
There are two groups, experimental and control group. Both groups formed by subjects Diagnosed with Alzheimer's disease.
The experimental group participated in a geriatric revitalization program with a physical activity, with sessions in homogeneous groups (groups of 5-8 subjects with similar cognitive impairment) for 6 months with a frequency of 3 sessions per week of 40-45 minutes, carried out in a Center specialized in the treatment of patients with Alzheimer's disease.
The sessions were conducted by a physiotherapist with more than 5 years of experience in the treatment of people with disabilities, dementias and Alzheimer's disease.
The sessions of geriatric revitalization are structured:
To start the session warm-up exercises are performed (walking, general exercises of joint mobility, with wide ranges of movement of upper and lower limbs and cervical spine fundamentally, during 3 minutes) and muscle stretching (gentle stretching of the main muscle groups of upper and lower limbs and the cervical spine, each one during 10 seconds and 2 repetitions). Aerobic endurance exercises are then performed (walking and depending on the capacity of the subjects of the group, the intensity can be increased almost to run, in two times, the first during 3 minutes and the second during 5-6 minutes, alternated with series of specific joint mobility of upper and lower limbs, normaly 2 sets of 10 repetitions each mobilization). Muscular strength (exercises with weights, manual resistance of the physiotherapist, elastic rubber bands, normaly 2 sets of 10 repetitions each exercise). Coordination, agility and balance exercises that can vary in duration according to the session and finally breathing exercises and relaxation to end the session.
At all times, the theoretical maximum heart rate (220-age) must be respected (periodically the heart rate is checked)
Intervention code [1] 301144 0
Rehabilitation
Comparator / control treatment
Subjects in the control group did not receive geriatric revitalization sessions or participate in another physical activity program during the six months of the study.
All of them only continued with their follow-up and medical treatment without programmed and structured physical activity.
Control group
Active

Outcomes
Primary outcome [1] 305843 0
Tinetti mobility test (total score): It consists of two tests: Balance test and gait test. Evaluate balance, gait and is used as a predictor of falls.
Timepoint [1] 305843 0
Four evaluations were made during the study in both groups. In the recruitment process, one month after the start of the intervention, three months after the start of the intervention and at the end of the follow-up, six months after the start of the intervention. (Primary timepoint not applicable)
Primary outcome [2] 305844 0
Timed Up and Go Test (s): is a functional measure to evaluate gait in a functional situation of daily living and is used as a predictor of falls.
Timepoint [2] 305844 0
Four evaluations were made during the study in both groups. In the recruitment process, one month after the start of the intervention, three months after the start of the intervention and at the end of the follow-up, six months after the start of the intervention. (Primary timepoint not applicable)
Primary outcome [3] 305846 0
T-Score: is a comparison of the average mineral density of the patient's bone with a healthy person of 30 years of the same sex and ethnicity. It was obtained by bone densitometry of the calcaneus with an ultrasonic densitometer Sahara® Clinical Bone Sonometer (Hologic®).
Timepoint [3] 305846 0
Four evaluations were made during the study in both groups. In the recruitment process, one month after the start of the intervention, three months after the start of the intervention and at the end of the follow-up, six months after the start of the intervention. (Primary timepoint not applicable)
Secondary outcome [1] 346738 0
One-legged stance test (s): evaluates the balance and is used as a predictor of falls
Timepoint [1] 346738 0
Four evaluations were made during the study in both groups. In the recruitment process, one month after the start of the intervention, three months after the start of the intervention and at the end of the follow-up, six months after the start of the intervention.
Secondary outcome [2] 346739 0
Functional reach test (cm): Evaluates the balance and is used as a predictor of falls in older people.
Timepoint [2] 346739 0
Four evaluations were made during the study in both groups. In the recruitment process, one month after the start of the intervention, three months after the start of the intervention and at the end of the follow-up, six months after the start of the intervention.
Secondary outcome [3] 346740 0
Speed of sound (SOS) (m/s): is the speed of the ultrasound conduction signal when cross the calcaneus from the transducer of the emitter to the transducer of the receiver with the densitometer. Is an indicator to determine the bone mineral density.
Timepoint [3] 346740 0
Four evaluations were made during the study in both groups. In the recruitment process, one month after the start of the intervention, three months after the start of the intervention and at the end of the follow-up, six months after the start of the intervention.
Secondary outcome [4] 346741 0
Broadband ultrasound attenuation (BUA) (dB / MHz): is the attenuation of broadband ultrasound when cross the calcaneus from the transducer of the emitter to the transducer of the receiver with the densitometer. Is an indicator to determine the bone mineral density.
Timepoint [4] 346741 0
Four evaluations were made during the study in both groups. In the recruitment process, one month after the start of the intervention, three months after the start of the intervention and at the end of the follow-up, six months after the start of the intervention.
Secondary outcome [5] 347020 0
number of falls during the study with the "WHO questionnaire for the study of falls in the elderly". Falls have also been used as a grouping variable (falls or does not fall)
Timepoint [5] 347020 0
Four evaluations were made during the study in both groups. In the recruitment process, one month after the start of the intervention, three months after the start of the intervention and at the end of the follow-up, six months after the start of the intervention.

Eligibility
Key inclusion criteria
• Medical diagnosis of Alzheimer's disease.
• Accept participation in the study (enrollment in the study and signing of informed consent).
• Be willing to carry out the Geriatrics Revitalization Program, without contraindications to the practice of physical activity.
Minimum age
40 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Failing to perform evaluation tests for severe cognitive impairment or physical alterations.
• Having some type of pathology at the beginning or during the program that clearly interferes with the evaluations or interventions of the study.
• Lack of adherence to the intervention program during the study. (3 consecutive absences or less than 75% attendance per month)

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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
Recruitment was for a non-probabilistic sample for convenience and consecutive when the subjects requested admission to the State Reference Center of Care for People with Alzheimer's Disease and other Dementias. Therefore, the calculation of the sample size was subject to the admission requests during the time of the study.
Some data was analysed, and other will be analysed by using the IBM-SPSS software package (version 23.0).
Means and standard deviations were calculated for each variable.
ANOVA test ( p > 0.05) was used at baseline to compare quantitative data of groups and a chi square test was used for categorical data.
Multivariate analysis of variance (MANOVA) with repeated measures will be used to assess differences between groups, with covariants, and pair-wise comparisons post-hoc.
The statistical analysis will be conducted at a 95% confidence level. A p-value < 0.05 will be considered to indicate statistical significance in all analyses.

Recruitment
Recruitment status
Completed
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] 10408 0
Spain
State/province [1] 10408 0
SALAMANCA

Funding & Sponsors
Funding source category [1] 299426 0
University
Name [1] 299426 0
University of Salamanca (Spain)
Address [1] 299426 0
Departament of Nursing and Physiotherapy
University School of Nursing and Physiotherapy
c/ Donante de sangre s/n (without number)
CP.: 37007 Salamanca
Spain
Country [1] 299426 0
Spain
Funding source category [2] 299502 0
Other Collaborative groups
Name [2] 299502 0
State Reference Center of Care for People with Alzheimer's Disease and Other Dementias in Salamanca
Address [2] 299502 0
C/ Cordel de Merinas de Chamberí, 117
CP.: 37008 Salamanca
Spain
Country [2] 299502 0
Spain
Primary sponsor type
University
Name
University of Salamanca (Spain)
Address
Departament of Nursing and Physiotherapy
University School of Nursing and Physiotherapy
c/ Donante de sangre s/n (without number)
CP.: 37007 Salamanca
Spain
Country
Spain
Secondary sponsor category [1] 298712 0
None
Name [1] 298712 0
Address [1] 298712 0
Country [1] 298712 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300327 0
Ethics committee of the University of Salamanca
Ethics committee address [1] 300327 0
Edificio Multiusos I+D+i
C/ Espejo 2, 2ª planta
37007 Salamanca (España)
Ethics committee country [1] 300327 0
Spain
Date submitted for ethics approval [1] 300327 0
14/09/2009
Approval date [1] 300327 0
02/10/2009
Ethics approval number [1] 300327 0
--

Summary
Brief summary
Main objective: to verify the efficacy of the Geriatric Revitalization Program, as a physical activity, on gait and balance through functional tests, the risk of falling and the values of bone mineral density in people diagnosed with Alzheimer's Disease.
Hypothesis 1: The application of a Geriatric Revitalization Program, as a physical activity, decreases the risk of falls in people diagnosed with Alzheimer's disease, improving gait and balance as functional parameters.
Hypothesis 2: The application of a Geriatric Revitalization Program, as a physical activity, reduces the loss of bone mineral density in people diagnosed with Alzheimer's disease.
Trial website
Trial related presentations / publications
None
Public notes
Attachments [1] 2715 2715 0 0
/AnzctrAttachments/375063-CCF06102014_00002.pdf (Ethics approval)

Contacts
Principal investigator
Name 83310 0
Dr Roberto Méndez Sánchez
Address 83310 0
University School of Nursing and Physiotherapy
c/ Donante de sangre s/n (without number)
CP.: 37007 Salamanca
Spain
Country 83310 0
Spain
Phone 83310 0
+34 923294590 ext.3201
Fax 83310 0
+34 923294576
Email 83310 0
ro_mendez@usal.es
Contact person for public queries
Name 83311 0
Dr Roberto Méndez Sánchez
Address 83311 0
University School of Nursing and Physiotherapy
c/ Donante de sangre s/n (without number)
CP.: 37007 Salamanca
Spain

Country 83311 0
Spain
Phone 83311 0
+34 923294590 ext.3201
Fax 83311 0
+34 923294576
Email 83311 0
ro_mendez@usal.es
Contact person for scientific queries
Name 83312 0
Dr Roberto Méndez Sánchez
Address 83312 0
University School of Nursing and Physiotherapy
c/ Donante de sangre s/n (without number)
CP.: 37007 Salamanca
Spain

Country 83312 0
Spain
Phone 83312 0
+34 923294590 ext.3201
Fax 83312 0
+34 923294576
Email 83312 0
ro_mendez@usal.es

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