Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000591752
Ethics application status
Approved
Date submitted
26/11/2021
Date registered
21/04/2022
Date last updated
21/04/2022
Date data sharing statement initially provided
21/04/2022
Date results provided
21/04/2022
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effects of a physical conditioning program in the aquatic environment on health indicators in the elderly.
Scientific title
Effects of a physical conditioning program in the aquatic environment on functional autonomy, physical condition, balance, psycho-social aspects and health indicators in elderly females.
Secondary ID [1] 305902 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Mental health 324459 0
fat mass 324460 0
blood pressure 324461 0
functional autonomy 324465 0
physical inactivity 324466 0
Condition category
Condition code
Musculoskeletal 321954 321954 0 0
Normal musculoskeletal and cartilage development and function
Cardiovascular 321955 321955 0 0
Hypertension
Mental Health 321956 321956 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention consisted of a training programme in an aquatic environment. Supervised resistance training was performed for 14 weeks. All sessions were conducted by a graduate in physical activity and sport sciences. The sessions were conducted in a heated pool three times a week for 60 min per session. The group was made up of all the women participants; the exercises were individual. The sessions began with a 15 min warm-up consisting of aerobic and resistance exercises (10 min) and stretching (5 min) of all the muscle groups involved, followed by 30 min of comprehensive interval resistance training involving four 5 min sessions with a 2 min rest between each session.

In each session, the same exercises (pectoral/back, hip flexor/extensor, biceps/triceps, knee flexor/extensor, shoulder and core) were performed for 1 min consecutively, with intervals of 30, 20 and 10 s and at low, moderate and high perceived intensity, respectively. According to the perceived exertion scale, when participants needed to increase the intensity of the upper hemisphere exercises, they put on resistance gloves or resistance dumbbells, whereas for the lower-hemisphere exercises, they put on resistance anklets.

Finally, in the last 10–15 min, stretching (5 min) and relaxation exercises (10 min) were performed. In all the intervention sessions, the perception of effort was controlled using the Borg scale.

Additionally, all participants received the same nutritional education, based on the mediterranean diet (MD) divided into four theoretical and practical workshops of 60 min for 14 weeks in order to provide updated information about the benefits of following an adequate food pattern. Trained dietitians conducted the sessions. The topics covered in the sessions were: (1) food and nutrition, MD pyramid and a modern lifestyle—daily, weekly and occasional dietary guidelines to achieve a healthy and balanced diet; (2) health and gastronomy—preparation of healthy menus that include components of the MD with an impact on cardiovascular prevention and cognitive deterioration; (3) MD associated with healthy aging, hydration and macro- and micronutrients; and (4) a seminar on sugars and sweeteners—presentation of the effects of sugar consumption on health and the evaluation of different types of sugars and sweeteners and processed products and risk of diseases associated with the consumption of foods not included in the MD. An attendance checklist was made, however, all the participants attended all the sessions, with the aim of standardizing the diet of the sample, to avoid eating habits being a potential confounding factor of the results obtained as an effect of the training.
Intervention code [1] 322298 0
Lifestyle
Intervention code [2] 322299 0
Behaviour
Comparator / control treatment
The control group received the nutritional education part, in the same way as the experimental group. However, they did not perform any type of physical exercise intervention.
Control group
Active

Outcomes
Primary outcome [1] 329710 0
Autonomy assesed by Autonomy-Supportive Coaching Questionnaire (ASCQ)
Timepoint [1] 329710 0
Baseline and after 14 weeks of intervention.
Primary outcome [2] 329712 0
Physical activity assessed by International physical activity questionnaire (IPAQ)
Timepoint [2] 329712 0
Baseline and after 14 weeks of intervention.
Primary outcome [3] 330885 0
Autonomy assesed by Basic Psychological Needs in Exercise Scale (BPNES)
Timepoint [3] 330885 0
Baseline and after 14 weeks of intervention.
Secondary outcome [1] 403560 0
Enjoyment, using the Intrinsic Motivation Inventory scale.
Timepoint [1] 403560 0
Baseline and after 14 weeks of intervention.
Secondary outcome [2] 403561 0
Eating habits assessed with a short questionnaire of 14 items, validated for the Spanish population and used by the Mediterranean Diet (MD) Prevention group (Predimed). The name of the questionnaire is Predimed.
Timepoint [2] 403561 0
Baseline and after 14 weeks of intervention.
Secondary outcome [3] 403562 0
Body composition measured by Anthropometry; skin folds, perimeters and diameters. Body perimeters were measured with an anthropometric tape. A pachymeter was used for the diameters. For the folds a plicometer was used.
Timepoint [3] 403562 0
Baseline and after 14 weeks of intervention.

Eligibility
Key inclusion criteria
To be over 60 years old; not to have undergone surgery in the last year; not to present musculoskeletal, neurological or orthopedic diseases that could affect the ability to perform the tests; to be able to walk independently without orthopedic assistance; and not to have previously performed any of the tests included in the study.
Minimum age
60 Years
Maximum age
75 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
To be a man, women under 60 years of age, women dieting at the time of the study with a nutritionist or doing physical activity outside the study.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Centralized computer randomization
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
1/10/2020
Date of last participant enrolment
Anticipated
Actual
1/11/2020
Date of last data collection
Anticipated
Actual
8/02/2021
Sample size
Target
45
Accrual to date
Final
40
Recruitment outside Australia
Country [1] 24353 0
Spain
State/province [1] 24353 0
Alicante

Funding & Sponsors
Funding source category [1] 310251 0
Self funded/Unfunded
Name [1] 310251 0
Bernardo José Cuestas Calero
Country [1] 310251 0
Spain
Primary sponsor type
Individual
Name
Alejandro Martínez Rodriguez
Address
University of Alicante
Department of Analytical Chemistry, Nutrition and Food Sciences
Faculty of Sciences
03690 San Vicente del Raspeig (Alicante)
Country
Spain
Secondary sponsor category [1] 311350 0
Individual
Name [1] 311350 0
Pablo Jorge Marcos Pardo
Address [1] 311350 0
University of Almería
SPORT Research Group (CTS-1024)
Area of Physical Education and Sport
Department of Education
Carretera Sacramento s/n, 04120 La Cañada de San Urbano, Almería (Spain)
Country [1] 311350 0
Spain

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309926 0
University Human Research Ethics Committee of the Catholic University of San Antonio (Murcia),
Ethics committee address [1] 309926 0
Ethics committee country [1] 309926 0
Spain
Date submitted for ethics approval [1] 309926 0
Approval date [1] 309926 0
07/06/2019
Ethics approval number [1] 309926 0

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

Contacts
Principal investigator
Name 115862 0
Dr Alejandro Martínez Rodriguez
Address 115862 0
University of Alicante
Department of Analytical Chemistry, Nutrition and Food Sciences
Faculty of Sciences
03690 San Vicente del Raspeig (Alicante)
Country 115862 0
Spain
Phone 115862 0
+34 696210163
Fax 115862 0
Email 115862 0
[email protected]
Contact person for public queries
Name 115863 0
Alejandro Martínez Rodriguez
Address 115863 0
University of Alicante
Department of Analytical Chemistry, Nutrition and Food Sciences
Faculty of Sciences
03690 San Vicente del Raspeig (Alicante)
Country 115863 0
Spain
Phone 115863 0
+34 696210163
Fax 115863 0
Email 115863 0
[email protected]
Contact person for scientific queries
Name 115864 0
Alejandro Martínez Rodriguez
Address 115864 0
University of Alicante
Department of Analytical Chemistry, Nutrition and Food Sciences
Faculty of Sciences
03690 San Vicente del Raspeig (Alicante)
Country 115864 0
Spain
Phone 115864 0
+34 696210163
Fax 115864 0
Email 115864 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



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.