Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624001475538
Ethics application status
Approved
Date submitted
7/10/2024
Date registered
18/12/2024
Date last updated
18/12/2024
Date data sharing statement initially provided
18/12/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Immediate and Long-term effectiveness of a Therapeutic Exercise Protocol in patients with Dementia
Scientific title
Immediate and Long-term effectiveness of a Therapeutic Exercise Protocol in patients with Dementia
Secondary ID [1] 313141 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
functional impairment 335402 0
dementia 335953 0
cognitive impairment 335954 0
Condition category
Condition code
Physical Medicine / Rehabilitation 331968 331968 0 0
Physiotherapy
Neurological 331969 331969 0 0
Dementias

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Subjects will be recruited from collaborating centers and will be informed of the development of this study, carrying out the process of information and informed consent with the subject or with the family member or guardian.
In a first interview, compliance with the eligibility criteria will be determined, for which the MMSE questionnaire will be administered and questions related to the health status that imply a possible exclusion from the study due to non-compliance with said criteria will be asked. Once compliance with the eligibility criteria has been confirmed and the desire to participate in the study has been corroborated, a first complete assessment will be carried out to determine the initial status of each subject.
Due to the impossibility of blinding the physiotherapist and the subject, and to minimize the risk of bias, the person responsible for carrying out the initial and final assessments will be completely unaware of the objective and protocol carried out in this study. Once the initial assessment is completed, the intervention process will begin with therapeutic exercise for 12 weeks, in groups of 3 persons, with the following characteristics:

- 45 minutes a day
- Moderate intensity in aerobic and strength exercises
or 60-75% Maximum heart rate
or Borg scale: 5-6
o 8-12 repetitions in strength exercises (30-50% 1RM)
- 3 days a week, on non-consecutive days:
o Day 1: Aerobic exercise + Strength exercise + Balance and flexibility exercises.
o Day 2: Aerobic exercise + Strength exercise + Balance and flexibility exercise
o Day 3: Aerobic exercise + Balance exercise + Task-oriented training

The exercise protocol recommended by the American College of Sports Medicine and current evidence maintains that the intervention should include aerobic exercise, muscle strengthening, balance and flexibility exercises. This protocol will also be accompanied by cognitive components, with the aim of improving executive functions, memory, attention and language. Therefore, during the performance of motor tasks, tasks related to language (listing colors, fruits, animals) and numerical tasks (counting backwards, simple addition or subtraction calculations, etc.) will be included.
The cognitive exercises will be performed during the specific physical exercises, working on double tasks.
Aerobic exercise will be performed using a bicycle or treadmill. Strengthening exercise will be performed using dumbbells, weights or elastic bands. They will be performed through large muscle groups, including 6-8 exercises, of 8-10 repetitions, with 2-3 sets each. A familiarization phase will be carried out with each exercise, and then the intensity will be adjusted according to the assigned group. Flexibility and balance exercises may include stretching, yoga or Pilates exercises, tandem or semi-tandem tasks, multi-directional movements and body weight transfers.
During the development of the session, the physiotherapist will monitor the heart rate to ensure that it is within the established range for moderate intensities. Likewise, the subject will be asked during the development of the exercises, what is the degree of perceived effort using the Borg scale, which must always remain within the corresponding range. At the end of each session, the physiotherapist will record the degree of fatigue and satisfaction with the therapy corresponding to the exercise performed.
After 12 weeks of intervention, the complete evaluation will be carried out again, collecting functional, cognitive, depression and functional independence data by an external examiner. Likewise, the physiotherapist satisfaction questionnaire will be administered to determine the degree of acceptance of the applied protocol, and to find out the details or difficulties that may have arisen during its application.
The data will be collected in a data notebook with an Excel database. Where adherence to the intervention, attendance at sessions, exercise diary, heart rate, degree of fatigue, etc.
Intervention code [1] 329712 0
Rehabilitation
Intervention code [2] 330094 0
Treatment: Other
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 339580 0
Postural Control
Timepoint [1] 339580 0
The different variables will be measured at the beginning of the intervention and a measurement completed after 12 weeks of intervention.
Primary outcome [2] 340062 0
balance and risk of falls
Timepoint [2] 340062 0
The different variables will be measured at the beginning of the intervention and a measurement completed after 12 weeks of intervention.
Primary outcome [3] 340063 0
basic activities of daily living
Timepoint [3] 340063 0
The different variables will be measured at the beginning of the intervention and a measurement completed after 12 weeks of intervention.
Secondary outcome [1] 440493 0
Depression
Timepoint [1] 440493 0
The different variables will be measured at the beginning of the intervention and a measurement completed after 12 weeks of intervention.
Secondary outcome [2] 442515 0
Executive functions, memory, abstraction language
Timepoint [2] 442515 0
The different variables will be measured at the beginning of the intervention and a measurement completed after 12 weeks of intervention.
Secondary outcome [3] 442516 0
Functional Independence
Timepoint [3] 442516 0
The different variables will be measured at the beginning of the intervention and a measurement completed after 12 weeks of intervention.

Eligibility
Key inclusion criteria

• Mild-moderate cognitive impairment (scores between 10 and 23 on the Mini-Mental State Examination (MMSE) scale).
Minimum age
65 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Comorbidities with other musculoskeletal or cardiovascular disorders that pose a limitation or contraindication to performing the therapeutic exercise protocol.
• Suffering from sequelae derived from SARS-CoV2 infection, or persistent COVID.
• Inability to walk independently.

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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The data will be analyzed using the SPSS statistical package (SPSS Inc., Chicago, IL). A statistical description will be made regarding the characteristics of the data set using the frequency distribution for the qualitative variable sex, and the mean and standard deviation for the quantitative variables.
The Shapiro-Wilk test will be performed to check the normal distribution of the quantitative variables (P > 0.05).
To compare the scores of the initial, final and follow-up assessment in each of the groups, the Student t test for related samples was used when the normal distribution of the data for these variables was confirmed and the Wilcoxon rank test as a non-parametric equivalent.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
7/01/2025
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
10
Accrual to date
Final
Recruitment outside Australia
Country [1] 26623 0
Spain
State/province [1] 26623 0
ÁVILA

Funding & Sponsors
Funding source category [1] 317584 0
University
Name [1] 317584 0
Catholic University of Ávila
Country [1] 317584 0
Spain
Primary sponsor type
Individual
Name
Elena Sánchez Jiménez/ Catholic University of Avila
Address
Country
Spain
Secondary sponsor category [1] 319889 0
Individual
Name [1] 319889 0
Mª Rosario Ferreira Jiménez / Catholic University of Avila
Address [1] 319889 0
Country [1] 319889 0
Spain

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316289 0
Clinical Research Ethics Committee of the Catholic University of Valencia
Ethics committee address [1] 316289 0
Ethics committee country [1] 316289 0
Spain
Date submitted for ethics approval [1] 316289 0
10/02/2023
Approval date [1] 316289 0
23/02/2023
Ethics approval number [1] 316289 0
UCV/2022-2023/134

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

Contacts
Principal investigator
Name 137410 0
Dr ELENA SANCHEZ JIMENEZ
Address 137410 0
Catholic University of Ávila C/Canteros S/N 05005 Ávila
Country 137410 0
Spain
Phone 137410 0
+034920251020
Fax 137410 0
Email 137410 0
[email protected]
Contact person for public queries
Name 137411 0
ELENA SANCHEZ JIMENEZ
Address 137411 0
Catholic University of Ávila C/Canteros S/N 05005 Ávila
Country 137411 0
Spain
Phone 137411 0
+034920251020
Fax 137411 0
Email 137411 0
[email protected]
Contact person for scientific queries
Name 137412 0
ELENA SANCHEZ JIMENEZ
Address 137412 0
Catholic University of Ávila C/Canteros S/N 05005 Ávila
Country 137412 0
Spain
Phone 137412 0
+034920251020
Fax 137412 0
Email 137412 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• Researchers who provide a methodologically sound proposal

Conditions for requesting access:
• -

What individual participant data might be shared?
• Sociodemographic data: sex, age, educational level, duration of the disease, institutionalization.
Independent variable: general functionality (SPPB), trunk control (Trunk Control Test), balance (Berg Balance Scale), general mobility and gait (Timed Up and Go Test) and degree of independence in activities of daily living (ADL) (Barthel Index)

What types of analyses could be done with individual participant data?
• Only to achieve the aims in the approved proposal

When can requests for individual participant data be made (start and end dates)?
From:
Start:07/01/2025
End: 15/05/2025

To:
-

Where can requests to access individual participant data be made, or data be obtained directly?
• [email protected]

Are there extra considerations when requesting access to individual participant data?
No


What supporting documents are/will be available?

TypeCitationLinkEmailOther DetailsAttachment
Informed consent form    Modelo Consentimiento Informado.pdf
Ethical approval    Dictamen favorable cÓMITÉ ÉTICO.pdf


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.