Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000149561
Ethics application status
Approved
Date submitted
30/05/2023
Date registered
16/02/2024
Date last updated
16/02/2024
Date data sharing statement initially provided
16/02/2024
Type of registration
Retrospectively registered

Titles & IDs
Public title
Implementation of a walking football programme
Scientific title
Study protocol for the implementation of a walking football programme: observation of effects differences between sexes
Secondary ID [1] 309719 0
Nil known
Universal Trial Number (UTN)
Trial acronym
WF (Walking Football)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Physical inactivity 330109 0
elderly 330706 0
physical condition 330707 0
happiness 330708 0
level of fat mass 330709 0
Condition category
Condition code
Public Health 326995 326995 0 0
Health promotion/education
Musculoskeletal 327549 327549 0 0
Normal musculoskeletal and cartilage development and function
Mental Health 327550 327550 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
1. Material:

The material for the intervention is as follows:
Soccer balls, cones and a 40x20 artificial grass space. Participants should wear appropriate clothing and footwear to practice soccer. They must also fill in the informed consent form in order to participate.

The material for data collection is as follows:

- Bioimpedance meter and thalymeter (Tanita MC-780 MA, Tanita Corporation, Tokyo, Japan).
- Digital dynamometer (TKK 5101 Grip-D; Takey, Tokyo, Japan).
- School chair
- Measuring tape
- Questionnaires: SF-12, Quality of Life (15D), and General Happiness Scale.

2. Procedures:

The recruitment process mainly involves promoting the activity among all the associations and organizations of elderly people in Cáceres, such as day centers, clubs, sports associations, neighborhood associations, university for the elderly, residences, etc., together with the help of the city council and the municipal sports institute. These social and institutional groups will help to disseminate a promotional poster or a written or online questionnaire to formalize the contact and obtain the necessary data from the participants. The form will contain the name and surname, age, time availability and telephone number.

The intervention will basically be to apply the adapted sport of walking soccer. A group of 14 people will play simultaneously (7 against 7). In an artificial turf space of 40x20m, the goals will be reduced to square meters and nobody will be the goalkeeper, in order to favor the motor time of all people.

The distribution of the minutes of each session will be as follows: 5 min general warm-up, 5 min specific warm-up, 45 minutes main part and 5 minutes of relaxation. The contents of each part are detailed below.

Each intervention session will have a warm-up divided into a general part, focused on joint mobility and global movements, e.g. flexion and extension of the hip and spine. A specific part with analytical exercises and more common in soccer, e. g. walking with the ball and changes of direction. The next part will be the classic game that can be complemented with technical-tactical exercises of soccer. It will end with relaxation and range of motion exercises to promote the return to the base state, e. g. hamstring and calf streches.


3. Who will carry out the intervention:

a person with a degree in physical activity and sports science

4. The mode of execution:
It will be face-to-face and in groups of between 10 and 14 people.

5. The number of times the intervention will be carried out:

24 sessions of 1 hour, twice a week for 12 weeks.

6. the place where the intervention takes place;

- Sports City of Cáceres (Sports Technification Center).
- Residence for the elderly.




There are no plans to personalize, adjust or adapt the intervention to individuals or groups of individuals in the intervention arm.

Adherence or fidelity to the intervention will be assessed by a roll call at each session and reported as a percentage, a minimum of 80% is required to participate. No strategies will be used to improve fidelity.
Intervention code [1] 326159 0
Treatment: Other
Intervention code [2] 326540 0
Lifestyle
Comparator / control treatment
The control group will continue with their normal life and routine during the study period, and will not include any activity or exercise similar to the one performed by the experimental group.
Control group
Active

Outcomes
Primary outcome [1] 334934 0
The Chair sit-and-reach test will be used to obtain the amplitude of movement. The distance will be measured in centimetres.

Tools: Using a school chair (40cm) and a tape measure to obtain the result.
Timepoint [1] 334934 0
Baseline and at the end of the intervention (at 3 months).
Primary outcome [2] 334935 0
To obtain the strength of the lower extremity musculature, the 30s Chair Stand test will be performed. The number of repetitions that can be performed will be counted.
Timepoint [2] 334935 0
Baseline and at the end of the intervention (at 3 months).
Primary outcome [3] 334936 0
To obtain the endurance strength, we will measure how many meters each participant can run in a time of 6 minutes in a rectangular circuit of 45.7 meters (50 yards).

Tools: cones, stopwatch, lap counter and measuring tape.
Timepoint [3] 334936 0
Baseline and at the end of the intervention (at 3 months).
Secondary outcome [1] 422484 0
To obtain the speed, the Brisk Walking test will be used, which is based on timing the time it takes each participant to walk a distance of 30 meters. The unit of measurement will be seconds. (Primary Outcomes)

Tools: stopwatch and measuring tape.
Timepoint [1] 422484 0
Baseline and at the end of the intervention (at 3 months).
Secondary outcome [2] 422485 0
To obtain the strength of the flexor muscles of the metacarpals, a digital dynamometer (TKK 5101 Grip-D; Takey, Tokyo, Japan) will be used. The unit of measurement will be kilograms.
Timepoint [2] 422485 0
Baseline and at the end of the intervention (at 3 months).
Secondary outcome [3] 422486 0
To obtain Health-Related Quality of Life or Perceived Health, will be used the 15 dimensions questionnaire. (Cronbach's alpha = 0.79). In each dimension, there are 5 response grades that are used to obtain a final measure between 0 and 1, where 0 represents the worst possible quality of life and 1 the best.
Timepoint [3] 422486 0
Baseline and at the end of the intervention (at 3 months).
Secondary outcome [4] 422487 0
To measure a person's overall well-being and health, a 12-question tool (Cronbach's alpha > 0.70), which is a shortened version of the SF-36 questionnaire, is available. This tool is composed of 8 dimensions (physical function, physical role, bodily pain, general health, vitality, social function, emotional role, mental health) and 2 summary components (physical and mental). The dimensions and components are scored on a scale from 0 to 100, where 0 represents the worst health status and 100 the best.
Timepoint [4] 422487 0
Baseline and at the end of the intervention (at 3 months).
Secondary outcome [5] 422488 0
The General Happiness Scale (Cronbach's alpha = 0.86) is used to evaluate happiness. It consists of 4 questions where the possible answers range from 1, which represents the worst happiness, to 7, which would be the best state of happiness.
Timepoint [5] 422488 0
Baseline and at the end of the intervention (at 3 months).
Secondary outcome [6] 422489 0
Body weight will be measured with a bioimpedance meter (Tanita MC-780 MA, Tanita Corporation, Tokyo, Japan).
Timepoint [6] 422489 0
Baseline and at the end of the intervention (at 3 months).
Secondary outcome [7] 425147 0
Percentage, fat-free mass will be measured with a bioimpedance meter (Tanita MC-780 MA, Tanita Corporation, Tokyo, Japan),
Timepoint [7] 425147 0
Baseline and at the end of the intervention (at 3 months).
Secondary outcome [8] 425148 0
Body mass index will be measured with a bioimpedance meter (Tanita MC-780 MA, Tanita Corporation, Tokyo, Japan), which will also be used to assess body composition parameters such as body fat percentage, fat-free mass, and total body water.
Timepoint [8] 425148 0
Baseline and at the end of the intervention (at 3 months).
Secondary outcome [9] 425150 0
To obtain adherence, a roll call will be taken at each session and 80% attendance will be required.

Tools: computer with Microsoft excel.
Timepoint [9] 425150 0
Each session

Eligibility
Key inclusion criteria
1) women and men over 60 years of age.
2) residing in the autonomous community of Extremadura.
3) not having any contraindication to exercise such as walking at moderate or high intensity. 4) signing the informed consent.
5) Intention to continue living in the same place, not moving to another city.
6) being able to walk independently and communicate.
Minimum age
60 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1) Have any medical contraindication
2) Surfing any injury
3) Other justified reasons

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomization using a randomization table created by a computer program (i.e. computerized 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
Recruiting
Date of first participant enrolment
Anticipated
Actual
9/01/2023
Date of last participant enrolment
Anticipated
4/03/2024
Actual
Date of last data collection
Anticipated
28/06/2024
Actual
Sample size
Target
60
Accrual to date
20
Final
Recruitment outside Australia
Country [1] 25563 0
Spain
State/province [1] 25563 0
Extremadura

Funding & Sponsors
Funding source category [1] 313912 0
Government body
Name [1] 313912 0
Extremadura Employment Service; TE-0038-21
Country [1] 313912 0
Spain
Primary sponsor type
Government body
Name
Extremadura Employment Service; TE-0038-21
Address
C. República Dominicana, 7, 06011 Badajoz
Country
Spain
Secondary sponsor category [1] 315770 0
None
Name [1] 315770 0
Address [1] 315770 0
Country [1] 315770 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313058 0
bioethics and biosafety committee of the University of Extremadura
Ethics committee address [1] 313058 0
Campus Universitario, Avda de Elvas, s/n 06071 - Badajoz, Spain
Ethics committee country [1] 313058 0
Spain
Date submitted for ethics approval [1] 313058 0
09/09/2022
Approval date [1] 313058 0
30/09/2022
Ethics approval number [1] 313058 0
149/2022

Summary
Brief summary
The overall objective of the project is to analyze, examine, study, investigate and evaluate the effects of 3 months of a walking soccer program on body composition, physical condition, quality of life, adherence and cost reduction in people over 60 years old. A randomized controlled trial will be used for 6 months with a total of 60 subjects (30 women and 30 men) assigned to two groups, body composition, aerobic endurance, upper body strength, lower body strength, speed-agility, flexibility, health-related quality of life and happiness will be measured. The main added value is the acquisition of new knowledge on the application of Walking Football programs in the elderly.
Hypothesis: The application of a Walking Football program for 6 months will improve physical condition and health-related quality of life in people over 60 years of age.
Trial website
Trial related presentations / publications
Public notes
The measurement procedures to obtain the variables (pre- and post-intervention) are as follows:
To perform all tests, individuals were required to wear comfortable and light clothing during the measurement process. Before taking the measurements, people will be asked to remove their shoes, socks and any heavy clothing, such as coats, sweaters, jackets, among others. They will also be asked to empty their pockets, remove their belts or any other objects, as well as remove any accessories they are wearing, such as pendants, rings, earrings, among others.
- Body composition: weight, height, fat mass and muscle mass will be measured with a bioimpedance meter (Tanita MC-780 MA, Tanita Corporation, Tokyo, Japan).
- Hand grip strength.
To obtain the strength of the metacarpal flexor muscles, a digital dynamometer (TKK 5101 Grip-D; Takey, Tokyo, Japan) will be used.
The starting position will be standing, holding the dynamometer with one hand at waist level and keeping it aligned with the forearm. The executing arm remains at the side of the body without touching it. The palm of the hand shall be parallel to the forearm muscle. The test should be performed by flexing the fingers of the hand with the maximum possible force and maintaining the position of the dynamometer with respect to the forearm present without flexing, extending or rotating the arm (ICC = 0.99).
The duration of the test should be brief, maximal and voluntary, so it will be 3 seconds to avoid fatigue.
Participants will perform two repetitions of each test with both hands alternately. The best result obtained in both tests for each hand will be selected.
- Lower limb strength.
The Chair Stand upright in chair, stand and sit test, for 30 seconds, consists of counting the number of times a person is able to stand up completely from a seated position, keeping the back straight and feet flat on the floor, without arm support, in a period of 30 seconds, (women ICC = 0.492, men ICC = 0.84).
- 6-min aerobic endurance
The test consists of measuring the distance that each participant is able to run in a time of 6 minutes in a rectangular circuit of 45.7 meters (50 yards, (ICC = 0.94).
- Speed-agility
The fast walking test is based on timing the time each participant takes to run a distance of 30 meters at maximum controlled speed, (ICC = 0.93). Two attempts will be made with a rest interval of 1 minute between them, and the best result obtained will be used for the analysis.
- Range of motion
The Chair sit-and-reach test consists of patients starting seated with one leg extended and bending slowly by sliding their hands down the leg until they touch or exceed their toes, (ICC = 0.95). The distance in centimeters will be measured and two attempts will be performed for each leg, recording the best result obtained in each one.

Contacts
Principal investigator
Name 126846 0
Dr María Mendoza Muñoz
Address 126846 0
Faculty of Sport Science, University of Extremadura.Avenida de la Universidad, s/n, 10003, Cáceres.
Country 126846 0
Spain
Phone 126846 0
+34 647093382
Fax 126846 0
Email 126846 0
[email protected]
Contact person for public queries
Name 126847 0
Mr Jofre Pisà Canyelles
Address 126847 0
Faculty of Sport Science, University of Extremadura.Avenida de la Universidad, s/n, 10003, Cáceres.
Country 126847 0
Spain
Phone 126847 0
+34 620639811
Fax 126847 0
Email 126847 0
[email protected]
Contact person for scientific queries
Name 126848 0
Mr Jofre Pisà Canyelles
Address 126848 0
Faculty of Sport Science, University of Extremadura.Avenida de la Universidad, s/n, 10003, Cáceres.
Country 126848 0
Spain
Phone 126848 0
+34 620639811
Fax 126848 0
Email 126848 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Data from questionnaires and physical tests
When will data be available (start and end dates)?
Immediately following publication, no end date; Beginning 3 months and ending 5 years following main results publication; no end date determined,
Available to whom?
only researchers who provide a methodologically sound proposal
Available for what types of analyses?
any purpose
How or where can data be obtained?
access subject to approvals by Principal Investigator ( [email protected])


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
19306Study protocol  [email protected]



Results publications and other study-related documents

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