Healthy Aged WomenNCT02506491
A Pilates Exercise Program for Improving Core Strength, Balance and Functional Autonomy in Aged Women
A study testing Pilates exercise and Muscular exercise in people with Healthy Aged Women, run by Universidad Católica San Antonio de Murcia.
Trial summary
This study is based on assess and contrast isometric and isokinetic core strength, static and dynamic balance, the number of falls, and functional autonomy in three different old women groups after a 18 weeks 1) Pilates-based structured exercise program, 2) muscular structured exercise program, and 3) nonexercising. Read more about this study
- Who is it for?
- Ages 60 to 80 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Aged Women
- What is being tested?
- Pilates exercise and Muscular exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Sep 2014to Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 80 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Women aged from 60 to 80 years, physically and mentally able to enroll in the exercise programs. The level of education, toxic habits, medical treatment and/or diseases that can affect musculoskeletal or cardiovascular systems, mental illness, urinary incontinence, the presence of oedema and high blood pressure will be controlled.
Who cannot join
- Current or prior participation in a structured Pilates-based or muscular exercise program in the past 3 months, and visual or auditory impairments not corrected with glasses or hearing aid. Each participant will also be at least 80% compliant to the exercise.
About this study
Official title: A Pilates Exercise Program for Improving Core Strength, Balance and Functional Autonomy in Aged Women: Study Protocol for a Randomized Controlled Trial
This study is based on assess and contrast isometric and isokinetic core strength, static and dynamic balance, the number of falls, and functional autonomy in three different old women groups after a 18 weeks 1) Pilates-based structured exercise program, 2) muscular structured exercise program, and 3) nonexercising.
Read the detailed description
Real life conditions require concurrent attention-demanding tasks, increasing the risk of falling and contributing to disability. Pilates-based exercise is proposed as a combined core and mental training program grounded on learning functionally effective postural sets and motor patterns, that will provide better results than a muscular exercise program in old women trunk strength, the risk of falling, functional autonomy and other complementary physical and mental functions. This is a 30-weeks quasi-experimental randomized controlled trial in which 80 independent old women will be allocated to a Pilates-based exercise program, a muscular exercise program, and a no-exercise control group. The intervention is divided into 18 weeks of supervised exercise and a 12 weeks follow-up. Primary outcome will be isokinetic and isometric trunk and hip flexion-extension strength, static and dynamic balance, the number of falls, and functional autonomy. Secondary outcome will include body composition, habitual physical activity and a standardized gerontological evaluation composed of body composition, daily physical activity, the independence to develop basic and instrumental activities of daily living, and the cognitive, affective and social function assessment. Every item will be measured at baseline, 18 and 30 weeks.
- Conditions
- Healthy Aged Women
- Being tested
- Pilates exercise, Muscular exercise, Control Group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pilates exerciseOther
2 sessions/week, 1 hour/session during 18 weeks. Intensity determined from 6 to 9 points, controlled by the Resistance exercise scale of perceived exertion (OMNI-RES).
Muscular exerciseOther
2 sessions/week, 1 hour/session during 18 weeks. Intensity determined from 6 to 9 points, controlled by the Resistance exercise scale of perceived exertion (OMNI-RES).
Control GroupOther
No exercise
| Study group | Role | What they receive |
|---|---|---|
| Pilates exercise program | Experimental | Incorporate Pilates principles to stimulate core muscles in a dynamic and static way, and exercising arms and legs complementarity with balance as an essential part of standing exercises. Receives: Other: Pilates exercise |
| Muscular exercise program | Experimental | To train core muscles in a dynamic and static way, and exercising arms and legs complementarity with balance as an essential part of standing exercises. Receives: Other: Muscular exercise |
| Control group | Active comparator | Healthy active but nonexercising old women Receives: Other: Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in trunk and hip isokinetic and isometric muscular flexion/extension peak torque, given in Newtons per meter.
assessed on a Biodex System III Pro Isokinetic Dynamometer (Biodex Medical System, NY, USA).
Measured: "Changes from baseline at 18 weeks" and "Changes from baseline at 30 weeks"
Secondary outcomes (10)
Changes in displacement of the center of pressure (millimeters) and time spent standing on two feet, tandem and monopodal display.
assessed with a portable force platform (Kistler, 9286AA).
Measured: Changes from baseline at 18 weeks" and "Changes from baseline at 30 weeks"
Changes in time spent to accomplish the Timed Up and Go test for dynamic balance
participants will be given instructions to stand up from a chair, walk 3 meters as quickly and safely as possible, turn around a cone, walk back and sit down.
Measured: "Changes from baseline at 18 weeks" and "Changes from baseline at 30 weeks"
number of falls
number of falls registration
Measured: participants will be followed every 4 weeks
Changes in time to accomplish the protocol GDLAM for assessing functional autonomy
protocol GDLAM consists of: 10 meters walking speed, standing up from a chair during 5 times, get up the floor from the ventral decubitus position, standing up from a chair and walk around a triangular circuit, and putting on and taking off a T-shirt.
Measured: Changes from baseline at 18 weeks" and "Changes from baseline at 30 weeks
Changes in bone mineral, lean mass (nonbone), and fat mass for total body, head, chest, trunk, hip, right and left legs and arms regions.
assessed with a dual-energy X-ray bone densitometry (XR-46, Norland Corp., Fort Atkinson, USA).
Measured: "Changes from baseline at 18 weeks" and "Changes from baseline at 30 weeks"
Changes in score from the Physical Activity Scale for the Elderly (PASE) to measure habitual physical activity.
The PASE is comprised of self-reported occupational, household and leisure items over a one-week period.
Measured: "Changes from baseline at 18 weeks" and "Changes from baseline at 30 weeks"
Changes in the Katz scale index to assess the independence to develop basic activities of daily living
It summarizes performance in six functions: namely, bathing, dressing, going to toilet, transferring, continence and feeding.
Measured: "Changes from baseline at 18 weeks" and "Changes from baseline at 30 weeks"
Changes in the Lawton and Brody's scale index to assess the independence to develop instrumental activities of daily living
It encomprises eight functional abilities, such as the use of the telephone, shopping, food preparation, housekeeping, laundry, mode of transport, taking medication and handling finances.
Measured: "Changes from baseline at 22 weeks" and "Changes from baseline at 34 weeks"
Changes in the Mini-Mental State score to assess the cognitive function
It covers orientation, memory, attention, calculation, recall and language
Measured: "Changes from baseline at 22 weeks" and "Changes from baseline at 34 weeks"
Changes in the Geriatric Depression Scale of Yesavage (GDSy) score to determine the affective function
It is composed of 15 questions that cover a wide variety of topics relevant to depression, such as somatic complaints, cognitive complaints, motivations, future/past orientation, self-image, losses, agitation, obsessive traits, and mood itself.
Measured: "Changes from baseline at 22 weeks" and "Changes from baseline at 34 weeks"
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2015 (estimated)
- Study startSep 2014
- Primary completionDec 2015
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Healthy Aged WomenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Católica San Antonio de Murcia
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Universitario Virgen de la Arrixaca
- Responsible party
- Principal investigator, Maria Carrasco, Universidad Católica San Antonio de Murcia
- Investigators
- Maria Carrasco, PhD, Study director, Universidad de AlmeriaDomingo J Ramos-Campo, PhD, Principal investigator, Universidad Católica San Antonio. MurciaJacobo A Rubio-Arias, PhD, Principal investigator, Universidad Católica San Antonio. MurciaDelia Reche-Orenes, PhD student, Principal investigator, Universidad Católica San Antonio. Murcia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02506491
- Sponsor's protocol ID
- PMAFI/24/14
- Status last verified
- Jul 2018
- First submitted
- 21 Jul 2015
- Last updated
- 5 Jul 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Carrasco M, Martínez I, Vaquero M. Cambios en la fuerza isométrica de las mujeres postmenopáusicas tras el ejercicio en el medio acuático. Revista Internacional de Medicina y Ciencias de la Actividad Física y el deporte 13(49): 73-85, 2013
Zaragoza AB, Carrasco M. Condición Física y estado de salud mental en mujeres mayores físicamente independientes. European Journal of Investigation in Health, Psychology and Education. 4(3): 289-300, 2014.
Carrasco M, Vaquero M. Training in a shallow pool: Its effect on upper extremity strength and total body weight in postmenopausal women. International SportMed Journal 12(1): 17-29, 2011
Carrasco M, Vaquero M. Water training in postmenopausal women: effect on muscular strength. European Journal of Sport Science 12(2): 193-200, 2011
Carrasco M, Reche D, Torres-Sobejano M, Romero E, Martínez I. Comparación de la movilidad del raquis entre mujeres de mediana edad practicantes de pilates y de otro tipo de ejercicio. Journal of Sport and Health Research 6(2): 169-176, 2014
González-Galvez N, Carrasco M, Marcos-Pardo PJ, Feito Y. The effect of Pilates Method in scholar's trunk strength and hamstring flexibility. Gender differences. International Journal of Medical, Health, Pharmaceutical and Biomedical Engineerin 8(6): 348-351, 2014.
Carrasco M, Martínez I, Navarro MD. Daily physical activity and bone mineral density in older women. Revista Brasileira de Medicina do Esporte 21(1): 22-26, 2015.
Carrasco-Poyatos M, Ramos-Campo DJ, Rubio-Arias JA. Pilates versus resistance training on trunk strength and balance adaptations in older women: a randomized controlled trial. PeerJ. 2019 Nov 14;7:e7948. doi: 10.7717/peerj.7948. eCollection 2019.
PubMed 31741786Carrasco-Poyatos M, Rubio-Arias JA, Ballesta-Garcia I, Ramos-Campo DJ. Pilates vs. muscular training in older women. Effects in functional factors and the cognitive interaction: A randomized controlled trial. Physiol Behav. 2019 Mar 15;201:157-164. doi: 10.1016/j.physbeh.2018.12.008. Epub 2018 Dec 8.
PubMed 30529737
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilates Exercise Program for Improving Core Strength, Balance and Functional Autonomy in Aged Women: Study Protocol for a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02506491
- Acronym / sponsor ID
- PMAFI/24/14
- Conditions
- Healthy Aged Women
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Universidad Católica San Antonio de MurciaUniversity, hospital or other
- Collaborators
- Hospital Universitario Virgen de la Arrixaca
- Study start
- Sep 2014
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 23 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is based on assess and contrast isometric and isokinetic core strength, static and dynamic balance, the number of falls, and functional autonomy in three different old women groups after a 18 weeks 1) Pilates-based structured exercise program, 2) muscular structured exercise program, and 3) nonexercising.
Detailed description
Real life conditions require concurrent attention-demanding tasks, increasing the risk of falling and contributing to disability. Pilates-based exercise is proposed as a combined core and mental training program grounded on learning functionally effective postural sets and motor patterns, that will provide better results than a muscular exercise program in old women trunk strength, the risk of falling, functional autonomy and other complementary physical and mental functions. This is a 30-weeks quasi-experimental randomized controlled trial in which 80 independent old women will be allocated to a Pilates-based exercise program, a muscular exercise program, and a no-exercise control group. The intervention is divided into 18 weeks of supervised exercise and a 12 weeks follow-up. Primary outcome will be isokinetic and isometric trunk and hip flexion-extension strength, static and dynamic balance, the number of falls, and functional autonomy. Secondary outcome will include body composition, habitual physical activity and a standardized gerontological evaluation composed of body composition, daily physical activity, the independence to develop basic and instrumental activities of daily living, and the cognitive, affective and social function assessment. Every item will be measured at baseline, 18 and 30 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Pilates exercise program | Experimental | Other: Pilates exerciseIncorporate Pilates principles to stimulate core muscles in a dynamic and static way, and exercising arms and legs complementarity with balance as an essential part of standing exercises. |
| Muscular exercise program | Experimental | Other: Muscular exerciseTo train core muscles in a dynamic and static way, and exercising arms and legs complementarity with balance as an essential part of standing exercises. |
| Control group | Active comparator | Other: Control GroupHealthy active but nonexercising old women |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Women aged from 60 to 80 years, physically and mentally able to enroll in the exercise programs. The level of education, toxic habits, medical treatment and/or diseases that can affect musculoskeletal or cardiovascular systems, mental illness, urinary incontinence, the presence of oedema and high blood pressure will be controlled.
Key exclusion criteria (1 listed)
- Current or prior participation in a structured Pilates-based or muscular exercise program in the past 3 months, and visual or auditory impairments not corrected with glasses or hearing aid. Each participant will also be at least 80% compliant to the exercise.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pilates exercise2 sessions/week, 1 hour/session during 18 weeks. Intensity determined from 6 to 9 points, controlled by the Resistance exercise scale of perceived exertion (OMNI-RES). | Other | Pilates exercise program |
| Muscular exercise2 sessions/week, 1 hour/session during 18 weeks. Intensity determined from 6 to 9 points, controlled by the Resistance exercise scale of perceived exertion (OMNI-RES). | Other | Muscular exercise program |
| Control GroupNo exercise | Other | Control group |
Primary outcome
Changes in trunk and hip isokinetic and isometric muscular flexion/extension peak torque, given in Newtons per meter.
Time frame: "Changes from baseline at 18 weeks" and "Changes from baseline at 30 weeks"
assessed on a Biodex System III Pro Isokinetic Dynamometer (Biodex Medical System, NY, USA).
10 secondary outcomes
Changes in displacement of the center of pressure (millimeters) and time spent standing on two feet, tandem and monopodal display.
Time frame: Changes from baseline at 18 weeks" and "Changes from baseline at 30 weeks"
Changes in time spent to accomplish the Timed Up and Go test for dynamic balance
Time frame: "Changes from baseline at 18 weeks" and "Changes from baseline at 30 weeks"
number of falls
Time frame: participants will be followed every 4 weeks
Changes in time to accomplish the protocol GDLAM for assessing functional autonomy
Time frame: Changes from baseline at 18 weeks" and "Changes from baseline at 30 weeks
Changes in bone mineral, lean mass (nonbone), and fat mass for total body, head, chest, trunk, hip, right and left legs and arms regions.
Time frame: "Changes from baseline at 18 weeks" and "Changes from baseline at 30 weeks"
Changes in score from the Physical Activity Scale for the Elderly (PASE) to measure habitual physical activity.
Time frame: "Changes from baseline at 18 weeks" and "Changes from baseline at 30 weeks"
Changes in the Katz scale index to assess the independence to develop basic activities of daily living
Time frame: "Changes from baseline at 18 weeks" and "Changes from baseline at 30 weeks"
Changes in the Lawton and Brody's scale index to assess the independence to develop instrumental activities of daily living
Time frame: "Changes from baseline at 22 weeks" and "Changes from baseline at 34 weeks"
Changes in the Mini-Mental State score to assess the cognitive function
Time frame: "Changes from baseline at 22 weeks" and "Changes from baseline at 34 weeks"
Changes in the Geriatric Depression Scale of Yesavage (GDSy) score to determine the affective function
Time frame: "Changes from baseline at 22 weeks" and "Changes from baseline at 34 weeks"
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2018.
- Results publicationCarrasco M, Martínez I, Vaquero M. Cambios en la fuerza isométrica de las mujeres postmenopáusicas tras el ejercicio en el medio acuático. Revista Internacional de Medicina y Ciencias de la Actividad Física y el deporte 13(49): 73-85, 2013
- Results publicationZaragoza AB, Carrasco M. Condición Física y estado de salud mental en mujeres mayores físicamente independientes. European Journal of Investigation in Health, Psychology and Education. 4(3): 289-300, 2014.
- Results publicationCarrasco M, Vaquero M. Training in a shallow pool: Its effect on upper extremity strength and total body weight in postmenopausal women. International SportMed Journal 12(1): 17-29, 2011
- Results publicationCarrasco M, Vaquero M. Water training in postmenopausal women: effect on muscular strength. European Journal of Sport Science 12(2): 193-200, 2011
- Results publicationCarrasco M, Reche D, Torres-Sobejano M, Romero E, Martínez I. Comparación de la movilidad del raquis entre mujeres de mediana edad practicantes de pilates y de otro tipo de ejercicio. Journal of Sport and Health Research 6(2): 169-176, 2014
- Results publicationGonzález-Galvez N, Carrasco M, Marcos-Pardo PJ, Feito Y. The effect of Pilates Method in scholar's trunk strength and hamstring flexibility. Gender differences. International Journal of Medical, Health, Pharmaceutical and Biomedical Engineerin 8(6): 348-351, 2014.
- Results publicationCarrasco M, Martínez I, Navarro MD. Daily physical activity and bone mineral density in older women. Revista Brasileira de Medicina do Esporte 21(1): 22-26, 2015.
- Derived from this study: PubMed 31741786Carrasco-Poyatos M, Ramos-Campo DJ, Rubio-Arias JA. Pilates versus resistance training on trunk strength and balance adaptations in older women: a randomized controlled trial. PeerJ. 2019 Nov 14;7:e7948. doi: 10.7717/peerj.7948. eCollection 2019.
- Derived from this study: PubMed 30529737Carrasco-Poyatos M, Rubio-Arias JA, Ballesta-Garcia I, Ramos-Campo DJ. Pilates vs. muscular training in older women. Effects in functional factors and the cognitive interaction: A randomized controlled trial. Physiol Behav. 2019 Mar 15;201:157-164. doi: 10.1016/j.physbeh.2018.12.008. Epub 2018 Dec 8.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maria Carrasco, PhD study director
Universidad de Almeria
Domingo J Ramos-Campo, PhD principal investigator
Universidad Católica San Antonio. Murcia
Jacobo A Rubio-Arias, PhD principal investigator
Universidad Católica San Antonio. Murcia
Questions about this trial
What is this clinical trial studying?
A study testing Pilates exercise and Muscular exercise in people with Healthy Aged Women, run by Universidad Católica San Antonio de Murcia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in trunk and hip isokinetic and isometric muscular flexion/extension peak torque, given in Newtons per meter. (time frame: "Changes from baseline at 18 weeks" and "Changes from baseline at 30 weeks"). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02506491, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jul 2018.