AgingGERIATICNCT03504813
Technologies for Participatory Medicine and Health Promotion in the Elderly Population
A study testing Physical activities program, Relaxation training and Training of the pelvic floor in people with Aging and Age Problem, run by Universidade da Coruña at 1 site in Spain.
Trial summary
Introduction: The progressive aging of the population is a socio-demographic phenomenon experienced by most countries in the world in recent decades, especially in Japan and in many European Union countries. During this process, so-called "geriatric syndromes" frequently occur. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Aging, Age Problem
- What is being tested?
- Physical activities program, Relaxation training and Training of the pelvic floor
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 1 siteSpain
- Study dates
- 1 Mar 2017to 31 Dec 2019
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- People 65 years of age or older.
- Specific criteria for each research line:
- Urinary incontinence:
- To have stress, urgency or mixed urinary incontinence
- To be a woman
- Insomnia:
Show all 11Show fewer
- Diagnosis of insomnia and/or hypersomnia.
- Risk of falls:
- To have a previous history of falls in the last 6-12 months.
- To present risk of falling and/or fear of falling.
- To have independence in locomotion.
Who cannot join
- Showing cognitive deterioration from moderate to very severe (Mini-Examination Cognitive minor of 20 points).
- Having severe, acute complications in health that prevent assiduity in attending interventions.
- Diagnosis of conditions and/or pathologies in which physical activity is contraindicated (mainly cardiorespiratory diseases).
- Being in the final stage of a terminal illness.
- Bing in a situation of request for transfer to another center.
- Having a temporary stay in elderly residence.
Show all 12Show fewer
- Having a situation of legal incapacity.
- For the research line on urinary incontinence, several specific exclusion criteria have been established:
- Having functional urinary incontinence because that type is related to cognitive deterioration, urinary infection, polypharmacy, psychological problems, endocrinopathy, mobility restriction, and fecal incontinence.
- Having undergone surgery in the pelvic floor area.
- Uterine prolapse, cystocele and/or rectocele (levels 3-4).
- No control of the pelvic floor.
Trial locations and contacts
1 site in 1 country.
About this study
Introduction: The progressive aging of the population is a socio-demographic phenomenon experienced by most countries in the world in recent decades, especially in Japan and in many European Union countries. During this process, so-called "geriatric syndromes" frequently occur. The focus of this study is the quality of life of the elderly in relation to these three factors: risk of falls, urinary incontinence, and insomnia.
Objective: The main purpose is to determine the impact of a multifactorial intervention program implemented with institutionalized elderly people. The program is focused on the treatment of the aforementioned factors.
Read more
Methods and Analysis: The study will be carried out with elderly people living in three residences for the elderly in A Coruña Province (Galicia, Spain).
It is a prospective and longitudinal study, with a temporary series design of a "quasi-experimental" type that evaluates the effect of an intervention in one given population by doing assessments pre- and post-intervention, but there is no comparison with a control group.
The intervention will be based on a multifactorial program, including the following phases: the use of wearable devices (wearable fitness trackers to register physical activity and sleep), the use of an App on a Tablet to record the participants' occupations and activities, counseling about performance in activities of daily living, the implementation of a physical activity program, and the treatment of the pelvic floor (according to each research line). The Quality of Life (QoL) will be assessed before and after the intervention, with the use of the questionnaire EuroQol-5D-5L. Data analysis will be applied with all registered variables through a quantitative perspective.
- Conditions
- Aging, Age Problem
- Being tested
- Physical activities program, Relaxation training, Training of the pelvic floor, Counseling about occupational performance
- Keywords
- Elderly, Quality of life, Wearables, Urinary incontinence, Insomnia, Risk of falls
- Medical subject headings
- Urinary Incontinence, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical activities programOther
To implement this line, the protocol of the VIVIFRAIL Project will be used as a reference. That protocol has different physical exercises, divided into itineraries, in order to adapt it to a person's capability. Several sessions of this research line will employ the use of videogames so that the elderly can explore new forms of physical activity and thus establish contact and expertise with new technologies. It is estimated that two sessions per week over two months are needed for each person to continue doing physical activity independently and with autonomy.
Relaxation trainingOther
Will take place with those participants who are included in the research lines of insomnia and risk of falls. It is estimated that two sessions per week for one month are needed.
Training of the pelvic floorOther
the intervention will apply to participants enrolled in the research line dealing with urinary incontinence during the six months of intervention, with a frequency of two sessions per week
Counseling about occupational performanceBehavioural
After the physical activity and relaxation programs, the counselling will start. With each participant, routines and daily activities will be planned that will be adequate according to different recommendations about urinary incontinence, insomnia and risk of falls. Different performance guidelines will be established in order to establish a good balance between activities. The guidelines can include the recommendations about adjustments to the environment. It is estimated that three sessions per week for two months are needed to incorporate advice and routines into the daily lives of participants.
| Study group | Role | What they receive |
|---|---|---|
| Urinary Incontinence | Experimental | The involuntary loss of urine through the urethra, objectively demonstrable and constituting for the person who suffers it a social and hygienic problem.
In this arm, participants will receive the following interventions: physical activities program, training of the pelvic floor and counseling about occupational performance Receives: Other: Physical activities program; Other: Training of the pelvic floor; Behavioral: Counseling about occupational performance |
| Insomnia | Experimental | A condition characterized by an unsatisfactory amount or quality of sleep which persists for a considerable period. This disorder includes difficulties for the falling and/or staying asleep and early awakening in the final phase of sleep.
In this arm, participants will receive the following interventions: physical activities program, relaxation training and counseling about occupational performance. Receives: Other: Physical activities program; Other: Relaxation training; Behavioral: Counseling about occupational performance |
| Risk of falls | Experimental | Involuntary events that cause people to lose balance and find themselves on the ground or other firm surfaces. The factor of falls can be intrinsic (related to the person) or extrinsic (derived from the activity or environment of the individual).
In this arm, participants will receive the following interventions: physical activities program, and counseling about occupational performance Receives: Other: Physical activities program; Behavioral: Counseling about occupational performance |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in the quality of life
The variable will be determined with EuroQol-5D-5L. This descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression.
Measured: Baseline and 6 months later (during intervention). Three months after intervention
Secondary outcomes (12)
Independence on Activities of Daily Living
Barthel Activities of Daily Living (ADL) Index: This tool is used as a simple index of independence to score the ability of a patient to care for himself, and by repeating the test periodically, to assess his improvement. The performance is assessed based on these scores: <20: total dependence, 20---40: severe dependence, 45-55: moderate dependence, and 60 or more: mild dependence.
Measured: Baseline and 6 months later (during intervention). Three months after intervention
Gait and balance
The test is scored on the individual's ability to perform specific tasks. "Scoring of the Tinetti Assessment Tool is done on a three-point ordinal scale with a range of 0 to 2. A score of 0 represents the most impairment, while a score of 2 represents independence. The individual scores are then combined to form three measures; an overall gait assessment score (12 points), an overall balance assessment score (16 points), and a combined gait and balance score (28).
Measured: Baseline and 6 months later (during intervention). Three months after intervention
Cognitive State
Mini-Mental State Examination (MMSE): This tool has been designed to determine the "cognitive state," that is one of the study's variables. It presents six values: one for each section (Orientation, Fixation, Concentration and calculation, Memory and Language, and Construction)
Measured: Baseline and 6 months later (during intervention). Three months after intervention
Oxford Grading Scale
This scale measures the variable of "pelvic floor contractile capacity". It has a unique numerical value (0-5), that is the result from assessment of the contractile capacity of the pelvic floor muscles
Measured: Baseline and 3 months after intervention
Sandvick Severity Index
This test assesses the variable "urine leakage". It presents a unique numerical value and consists of two questions, one of them about the frequency with which a person has urine leakage (maximum score of 4 points) and another with reference to the amount of urine in the exhaust (maximum score of 3 points)
Measured: Baseline and 3 months after intervention
24-Hour Pad Test
This tool allows to measure the "amount of urine". This scale has three values (net weight of the napkin/diaper, weight with urine and weight difference).
Measured: Baseline and 6 months later (during intervention). Three months after intervention
Pelvic Floor Muscle Assessment: PERFECT Scheme
The tool PERFECT Scheme allows to assess the "pelvic floor musculature". PERFECT is an acronym with P representing power (or pressure, a measure of strength using a manometric perineometer), E = endurance, R = repetitions, F = fast contractions, and ECT = every contraction timed.
Measured: Baseline and 6 months later (during intervention). Three months after intervention
International Consultation on Incontinence Questionnaire (Short Form)
Self-administered questionnaire that qualifies the "symptoms and quality of life" in both male and female adult patients with symptoms of urine loss. It has 6 items, Score is 0 - 21 with a higher score indicating greater severity.
Measured: Baseline and 6 months later (during intervention). Three months after intervention
Oviedo Sleep Questionnaire
This scale allows assess the "sleep satisfaction". It consists of 13 items with three values: one for each section (sleep satisfaction, insomnia and hypersomnia). Each item is scored from 1 to 5, except for item 1 which is scored from 1 to 7. The subscale of insomnia ranges from 9 to 45 points; the higher the score the greater the severity.
Measured: Baseline and 6 months later (during intervention). Three months after intervention
Pittsburgh Sleep Quality Assessment
The measure consists of 19 individual items, creating seven components that produce one global score. Each item is weighted on a 0-3 interval scale. The global PSQI score is then calculated by totaling the seven component scores, providing an overall score ranging from 0 to 21, where lower scores denote a healthier sleep quality.
Measured: Baseline and 6 months later (during intervention). Three months after intervention
Timed Get Up and Go Test
A simple test used to assess a person's mobility and requires both static and dynamic balance
Measured: Baseline and 6 months later (during intervention). Three months after intervention
Falls Efficacy Scale International
The tool measures "the level of concern about falling" during social and physical activities inside and outside the home. Individuals are asked to rate, on a four-point Likert scale,their concerns aboutthe possibility offalling when performing 16 activities.The scores are added up to calculate a total score that ranges from 16 to 64 for the FES-I and 8 to 28 for the short FES-I. A higher score indicates a greater fear of falls
Measured: Baseline and 6 months later (during intervention). Three months after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2018
- Study start1 Mar 2017
- Primary completion30 Nov 2018
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for AgingStudies 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
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade da Coruña
- Sponsor type
- University, hospital or other
- Collaborators
- Geriatros, Center on Information and Communication Technologies, Instituto de Investigacion Biomedica de A Coruna, Aldaba, Cobián Clinic
- Responsible party
- Principal investigator, Javier Pereira, Universidade da Coruña
- Investigators
- Javier P Pereira, PhD, Principal investigator, Universidade da Coruña
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03504813
- Sponsor's protocol ID
- IN852A 2016/10
- Acronym
- GERIATIC
- Status last verified
- Oct 2020
- First submitted
- 6 Apr 2018
- Last updated
- 19 Oct 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Abrams P, Cardozo L, Fall M, Griffiths D, Rosier P, Ulmsten U, van Kerrebroeck P, Victor A, Wein A; Standardisation Sub-committee of the International Continence Society. The standardisation of terminology of lower urinary tract function: report from the Standardisation Sub-committee of the International Continence Society. Neurourol Urodyn. 2002;21(2):167-78. doi: 10.1002/nau.10052. No abstract available.
PubMed 11857671Gershenfeld N, Krikorian R, Cohen D. The Internet of things. Sci Am. 2004 Oct;291(4):76-81. doi: 10.1038/scientificamerican1004-76. No abstract available.
PubMed 15487673Chan AW, Tetzlaff JM, Altman DG, Laupacis A, Gotzsche PC, Krle A-Jeric K, Hrobjartsson A, Mann H, Dickersin K, Berlin JA, Dore CJ, Parulekar WR, Summerskill WS, Groves T, Schulz KF, Sox HC, Rockhold FW, Rennie D, Moher D. SPIRIT 2013 Statement: defining standard protocol items for clinical trials. Rev Panam Salud Publica. 2015 Dec;38(6):506-14.
PubMed 27440100Davies A, De Souza LH, Frank AO. Changes in the quality of life in severely disabled people following provision of powered indoor/outdoor chairs. Disabil Rehabil. 2003 Mar 18;25(6):286-90. doi: 10.1080/0963828021000043734.
PubMed 12623619Stier-Jarmer M, Grill E, Muller M, Strobl R, Quittan M, Stucki G. Validation of the comprehensive ICF Core Set for patients in geriatric post-acute rehabilitation facilities. J Rehabil Med. 2011 Jan;43(2):102-12. doi: 10.2340/16501977-0617.
PubMed 21042699Wade DT, Collin C. The Barthel ADL Index: a standard measure of physical disability? Int Disabil Stud. 1988;10(2):64-7. doi: 10.3109/09638288809164105.
PubMed 3042746Tinetti ME. Performance-oriented assessment of mobility problems in elderly patients. J Am Geriatr Soc. 1986 Feb;34(2):119-26. doi: 10.1111/j.1532-5415.1986.tb05480.x. No abstract available.
PubMed 3944402Folstein MF, Folstein SE, McHugh PR. "Mini-mental state". A practical method for grading the cognitive state of patients for the clinician. J Psychiatr Res. 1975 Nov;12(3):189-98. doi: 10.1016/0022-3956(75)90026-6. No abstract available.
PubMed 1202204Charlson M, Szatrowski TP, Peterson J, Gold J. Validation of a combined comorbidity index. J Clin Epidemiol. 1994 Nov;47(11):1245-51. doi: 10.1016/0895-4356(94)90129-5.
PubMed 7722560Ferreira CH, Barbosa PB, de Oliveira Souza F, Antonio FI, Franco MM, Bo K. Inter-rater reliability study of the modified Oxford Grading Scale and the Peritron manometer. Physiotherapy. 2011 Jun;97(2):132-8. doi: 10.1016/j.physio.2010.06.007. Epub 2010 Oct 22.
PubMed 21497247Sandvik H, Seim A, Vanvik A, Hunskaar S. A severity index for epidemiological surveys of female urinary incontinence: comparison with 48-hour pad-weighing tests. Neurourol Urodyn. 2000;19(2):137-45. doi: 10.1002/(sici)1520-6777(2000)19:23.0.co;2-g.
PubMed 10679830Badia Llach X, Castro Diaz D, Perales Cabanas L, Pena Outerino JM, Martinez-Agullo E, Conejero Sugranes J, Arano Beltran P, Marques Queimadelos A, Roset Gamisans M, Perulero Escobar N. [The development and preliminary validation of the IU-4 questionnaire for the clinical classification of urinary incontinence]. Actas Urol Esp. 1999 Jul-Aug;23(7):565-72. Spanish.
PubMed 10488609Krhut J, Zachoval R, Smith PP, Rosier PF, Valansky L, Martan A, Zvara P. Pad weight testing in the evaluation of urinary incontinence. Neurourol Urodyn. 2014 Jun;33(5):507-10. doi: 10.1002/nau.22436. Epub 2013 Jun 24.
PubMed 23797972Buysse DJ, Reynolds CF 3rd, Monk TH, Berman SR, Kupfer DJ. The Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and research. Psychiatry Res. 1989 May;28(2):193-213. doi: 10.1016/0165-1781(89)90047-4.
PubMed 2748771Podsiadlo D, Richardson S. The timed "Up & Go": a test of basic functional mobility for frail elderly persons. J Am Geriatr Soc. 1991 Feb;39(2):142-8. doi: 10.1111/j.1532-5415.1991.tb01616.x.
PubMed 1991946
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Technologies for Participatory Medicine and Health Promotion in the Elderly Population
- ClinicalTrials.gov ID
- NCT03504813
- Acronym / sponsor ID
- GERIATIC / IN852A 2016/10
- Conditions
- Aging, Age Problem
- Keywords
- Elderly, Quality of life, Wearables, Urinary incontinence, Insomnia, Risk of falls
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Universidade da CoruñaUniversity, hospital or other
- Collaborators
- Geriatros, Center on Information and Communication Technologies, Instituto de Investigacion Biomedica de A Coruna, Aldaba, Cobián Clinic
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- 30 Nov 2018 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 20 Apr 2018 (actual)
- 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.
Introduction: The progressive aging of the population is a socio-demographic phenomenon experienced by most countries in the world in recent decades, especially in Japan and in many European Union countries. During this process, so-called "geriatric syndromes" frequently occur. The focus of this study is the quality of life of the elderly in relation to these three factors: risk of falls, urinary incontinence, and insomnia.
Objective: The main purpose is to determine the impact of a multifactorial intervention program implemented with institutionalized elderly people. The program is focused on the treatment of the aforementioned factors.
Methods and Analysis: The study will be carried out with elderly people living in three residences for the elderly in A Coruña Province (Galicia, Spain).
It is a prospective and longitudinal study, with a temporary series design of a "quasi-experimental" type that evaluates the effect of an intervention in one given population by doing assessments pre- and post-intervention, but there is no comparison with a control group.
The intervention will be based on a multifactorial program, including the following phases: the use of wearable devices (wearable fitness trackers to register physical activity and sleep), the use of an App on a Tablet to record the participants' occupations and activities, counseling about performance in activities of daily living, the implementation of a physical activity program, and the treatment of the pelvic floor (according to each research line). The Quality of Life (QoL) will be assessed before and after the intervention, with the use of the questionnaire EuroQol-5D-5L. Data analysis will be applied with all registered variables through a quantitative perspective.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Urinary Incontinence | Experimental | Other: Physical activities program, Other: Training of the pelvic floor, Behavioral: Counseling about occupational performanceThe involuntary loss of urine through the urethra, objectively demonstrable and constituting for the person who suffers it a social and hygienic problem. In this arm, participants will receive the following interventions: physical activities program, training of the pelvic floor and counseling about occupational performance |
| Insomnia | Experimental | Other: Physical activities program, Other: Relaxation training, Behavioral: Counseling about occupational performanceA condition characterized by an unsatisfactory amount or quality of sleep which persists for a considerable period. This disorder includes difficulties for the falling and/or staying asleep and early awakening in the final phase of sleep. In this arm, participants will receive the following interventions: physical activities program, relaxation training and counseling about occupational performance. |
| Risk of falls | Experimental | Other: Physical activities program, Behavioral: Counseling about occupational performanceInvoluntary events that cause people to lose balance and find themselves on the ground or other firm surfaces. The factor of falls can be intrinsic (related to the person) or extrinsic (derived from the activity or environment of the individual). In this arm, participants will receive the following interventions: physical activities program, and counseling about occupational performance |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (11 listed)
- People 65 years of age or older.
- Urinary incontinence:
- Insomnia:
- Risk of falls:
Key exclusion criteria (12 listed)
- Showing cognitive deterioration from moderate to very severe (Mini-Examination Cognitive minor of 20 points).
- Having severe, acute complications in health that prevent assiduity in attending interventions.
- Diagnosis of conditions and/or pathologies in which physical activity is contraindicated (mainly cardiorespiratory diseases).
- Being in the final stage of a terminal illness.
- Bing in a situation of request for transfer to another center.
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 |
|---|---|---|
| Physical activities programTo implement this line, the protocol of the VIVIFRAIL Project will be used as a reference. That protocol has different physical exercises, divided into itineraries, in order to adapt it to a person's capability. Several sessions of this research line will employ the use of videogames so that the elderly can explore new forms of physical activity and thus establish contact and expertise with new technologies. It is estimated that two sessions per week over two months are needed for each person to continue doing physical activity independently and with autonomy. | Other | Insomnia, Risk of falls, Urinary Incontinence |
| Relaxation trainingWill take place with those participants who are included in the research lines of insomnia and risk of falls. It is estimated that two sessions per week for one month are needed. | Other | Insomnia |
| Training of the pelvic floorthe intervention will apply to participants enrolled in the research line dealing with urinary incontinence during the six months of intervention, with a frequency of two sessions per week | Other | Urinary Incontinence |
| Counseling about occupational performanceAfter the physical activity and relaxation programs, the counselling will start. With each participant, routines and daily activities will be planned that will be adequate according to different recommendations about urinary incontinence, insomnia and risk of falls. Different performance guidelines will be established in order to establish a good balance between activities. The guidelines can include the recommendations about adjustments to the environment. It is estimated that three sessions per week for two months are needed to incorporate advice and routines into the daily lives of participants. | Behavioural | Insomnia, Risk of falls, Urinary Incontinence |
Primary outcome
Changes in the quality of life
Time frame: Baseline and 6 months later (during intervention). Three months after intervention
The variable will be determined with EuroQol-5D-5L. This descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression.
12 secondary outcomes
Independence on Activities of Daily Living
Time frame: Baseline and 6 months later (during intervention). Three months after intervention
Gait and balance
Time frame: Baseline and 6 months later (during intervention). Three months after intervention
Cognitive State
Time frame: Baseline and 6 months later (during intervention). Three months after intervention
Oxford Grading Scale
Time frame: Baseline and 3 months after intervention
Sandvick Severity Index
Time frame: Baseline and 3 months after intervention
24-Hour Pad Test
Time frame: Baseline and 6 months later (during intervention). Three months after intervention
Pelvic Floor Muscle Assessment: PERFECT Scheme
Time frame: Baseline and 6 months later (during intervention). Three months after intervention
International Consultation on Incontinence Questionnaire (Short Form)
Time frame: Baseline and 6 months later (during intervention). Three months after intervention
Oviedo Sleep Questionnaire
Time frame: Baseline and 6 months later (during intervention). Three months after intervention
Pittsburgh Sleep Quality Assessment
Time frame: Baseline and 6 months later (during intervention). Three months after intervention
Timed Get Up and Go Test
Time frame: Baseline and 6 months later (during intervention). Three months after intervention
Falls Efficacy Scale International
Time frame: Baseline and 6 months later (during intervention). Three months after intervention
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 19 Oct 2020.
- Background: PubMed 11857671Abrams P, Cardozo L, Fall M, Griffiths D, Rosier P, Ulmsten U, van Kerrebroeck P, Victor A, Wein A; Standardisation Sub-committee of the International Continence Society. The standardisation of terminology of lower urinary tract function: report from the Standardisation Sub-committee of the International Continence Society. Neurourol Urodyn. 2002;21(2):167-78. doi: 10.1002/nau.10052. No abstract available.
- Background: PubMed 15487673Gershenfeld N, Krikorian R, Cohen D. The Internet of things. Sci Am. 2004 Oct;291(4):76-81. doi: 10.1038/scientificamerican1004-76. No abstract available.
- Background: PubMed 27440100Chan AW, Tetzlaff JM, Altman DG, Laupacis A, Gotzsche PC, Krle A-Jeric K, Hrobjartsson A, Mann H, Dickersin K, Berlin JA, Dore CJ, Parulekar WR, Summerskill WS, Groves T, Schulz KF, Sox HC, Rockhold FW, Rennie D, Moher D. SPIRIT 2013 Statement: defining standard protocol items for clinical trials. Rev Panam Salud Publica. 2015 Dec;38(6):506-14.
- Background: PubMed 12623619Davies A, De Souza LH, Frank AO. Changes in the quality of life in severely disabled people following provision of powered indoor/outdoor chairs. Disabil Rehabil. 2003 Mar 18;25(6):286-90. doi: 10.1080/0963828021000043734.
- Background: PubMed 21042699Stier-Jarmer M, Grill E, Muller M, Strobl R, Quittan M, Stucki G. Validation of the comprehensive ICF Core Set for patients in geriatric post-acute rehabilitation facilities. J Rehabil Med. 2011 Jan;43(2):102-12. doi: 10.2340/16501977-0617.
- Background: PubMed 3042746Wade DT, Collin C. The Barthel ADL Index: a standard measure of physical disability? Int Disabil Stud. 1988;10(2):64-7. doi: 10.3109/09638288809164105.
- Background: PubMed 3944402Tinetti ME. Performance-oriented assessment of mobility problems in elderly patients. J Am Geriatr Soc. 1986 Feb;34(2):119-26. doi: 10.1111/j.1532-5415.1986.tb05480.x. No abstract available.
- Background: PubMed 1202204Folstein MF, Folstein SE, McHugh PR. "Mini-mental state". A practical method for grading the cognitive state of patients for the clinician. J Psychiatr Res. 1975 Nov;12(3):189-98. doi: 10.1016/0022-3956(75)90026-6. No abstract available.
- Background: PubMed 7722560Charlson M, Szatrowski TP, Peterson J, Gold J. Validation of a combined comorbidity index. J Clin Epidemiol. 1994 Nov;47(11):1245-51. doi: 10.1016/0895-4356(94)90129-5.
- Background: PubMed 21497247Ferreira CH, Barbosa PB, de Oliveira Souza F, Antonio FI, Franco MM, Bo K. Inter-rater reliability study of the modified Oxford Grading Scale and the Peritron manometer. Physiotherapy. 2011 Jun;97(2):132-8. doi: 10.1016/j.physio.2010.06.007. Epub 2010 Oct 22.
- Background: PubMed 10679830Sandvik H, Seim A, Vanvik A, Hunskaar S. A severity index for epidemiological surveys of female urinary incontinence: comparison with 48-hour pad-weighing tests. Neurourol Urodyn. 2000;19(2):137-45. doi: 10.1002/(sici)1520-6777(2000)19:23.0.co;2-g.
- Background: PubMed 10488609Badia Llach X, Castro Diaz D, Perales Cabanas L, Pena Outerino JM, Martinez-Agullo E, Conejero Sugranes J, Arano Beltran P, Marques Queimadelos A, Roset Gamisans M, Perulero Escobar N. [The development and preliminary validation of the IU-4 questionnaire for the clinical classification of urinary incontinence]. Actas Urol Esp. 1999 Jul-Aug;23(7):565-72. Spanish.
- Barry A, McGwire S PK. Global AgeWatch Index 2015 \[Internet\]. Age International, editor. 2015Link provided by the sponsor.
- Instituto Nacional de Estadistica. (Spanish Statistical Office)Link provided by the sponsor.
- World Health Organization. ICD-10 Version:2008 \[Internet\]. WHO, editor. Genebra; 2008Link provided by the sponsor.
- World Health Orgnization. WHO \| Falls \[Internet\]. WHO. World Health Organization; 2018Link provided by the sponsor.
- Alberich T, Barranco Carrillo A, Funes Jiménez E, Espadas Alcázar MA, Melón González O. Intervención social y sanitaria con mayores manual para el trabajo con la 3a. y 4a. edad.Link provided by the sponsor.
- Millán Calenti JC. Gerontología y geriatría : valoración e intervención \[Internet\]. Editorial Médica Panamericana; 2011Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Alzheimer's Disease
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Colon-delivered Riboflavin and Gut Microbiota Composition
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Metformin as an add-on or Monotherapy in Treatment of Aging People With Multiple Sclerosis (MS)
Multiple Sclerosis
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Validation & Intervention Testing for Aging, Longevity and Healthspan
Aging, Functional Decline
RecruitingObservational study
Effects of Obesity on Physical Abilities and Daily Living Activities in Elderly Adults
Obesity, Sarcopenic Obesity
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.
Javier P Pereira, PhD principal investigator
Universidade da Coruña
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical activities program, Relaxation training and Training of the pelvic floor in people with Aging and Age Problem, run by Universidade da Coruña at 1 site in Spain.
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 11 inclusion and 12 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 19 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
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 the quality of life (time frame: Baseline and 6 months later (during intervention). Three months after intervention). 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 NCT03504813, which also lists 17 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 19 Oct 2020.