CaregiverNCT03675217
Physical Exercise Program for Family Caregivers of Dependent Patients
A study testing PE in people with Caregiver and Physical Activity, run by Fundacion para la Investigacion y Formacion en Ciencias de la Salud at 1 site in Spain.
Trial summary
This estudy evaluates the effects of physical exercise program on health related quality of life (HRQoL), pain and physical fitness in family caregiver. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Caregiver, Physical Activity
- What is being tested?
- PE
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteSpain
- Study dates
- 14 Sep 2015to 20 Jun 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 18 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Status as family caregiver and to be incluided in the "Caregiver care Program".
- Provided care to family dependent al least 6 months.
- Accept to participate in the study and sign the informed consent.
- No changes in medication for at least 3 months prior to study entry.
Who cannot join
- People whith associated pathologies that make it impossible to perform physical exercise program (moderate-intensity exercise).
- To be incluiding in other family care program
- Participation in any regular physical activity program.
- To have a formal caregiver to care for the dependent family member
Trial locations and contacts
1 site in 1 country.
Spain1 site
Gerencia de Atención Primaria Valladolid-Este
Valladolid, Valladlid, 47010
About this study
Official title: Physical Exercise Program for Family Caregivers of Dependent Patients: Randomized Clinical Trial in Primary Health Care
This estudy evaluates the effects of physical exercise program on health related quality of life (HRQoL), pain and physical fitness in family caregiver.
Read the detailed description
Justification: Research indicates that the dependent patient caregiver´s have physical, psychological and social repercussions, as consequence of the care that they provide. From Primary Health Care there is a "caregiver care program" to prevent and palliate this situation, consisting mainly in education programs in care and psychotherapy. There is controversy about the effectiveness of these programs, being necessary to develop new therapeutic strategies.
Objectives: to determine the effects of a physical exercise program, adressed by the primary health care physioterapist, on health related quality of life (HRQol), pain and physical fitness in dependent patient caregivers included in the " caregiver care program" of a basic health area.
Methodology: randomized clinical trial, with control group (GC = 32) and intervention group (GI = 36), double blind and pre and post-intervention evaluation. The GC received the usual program of the " caregiver care program". The GI also carried out a multi-component exercise program for 12 weeks, with 3 weekly sessions realized in group and monitored by physiotherapists. The outcomes variables are measured by Quality of life (SF-36), Burden (Zarit), anxiety (Goldberg Ansiety Questionanaire), depression (Yesavage Questionnaire), pain intensity (EVA), disability (Roland Morris) and physical fitness (battery of fitness tests). Patients evaluator and Outcomes Assessor are masked.
Applicability of results: If the physical exercise program, carried out from the primary health care physiotherapy, improves the HRQol, pain and physical fitness, this intervention could be an effective therapeutic strategy in the "caregiver care programs". Furthermore the proposed intervention is simple, reproducible and requires few resources.
- Conditions
- Caregiver, Physical Activity
- Being tested
- PE, Usual Care
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PEOther
Physical exercise program for familiy caregivers. 36 session physical exercise (3 sessions/week) performed by physioterapist. It incluided exercices to improve coordination, aerobic capacity, control motor and strenght
Usual CareOther
Usual Programe in primary care for family caregivers. 4 session (2 session/week). It incluides: ergonomy, postural hygiene, mobilitation of patients and self-care.
| Study group | Role | What they receive |
|---|---|---|
| PE and PCFPC | Experimental | Physical Exercise and primary care family caregivers program Receives: Other: PE; Other: Usual Care |
| Usual Care | Active comparator | Usual Care: PCFPC (primary care family caregivers program) Receives: Other: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Health-related Quality of Life at different time point
Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36) V2. Spanish version. The SF-36 is a 36- item scale constructed to survey health status and quality of life. It yields an 8-scale profile of functional health and well-being scores as well as psychometrically-based physical and mental health summary. Each scale is directly transformed into a 0-100 scale. Higher scores indicate better overall quality of life.
Measured: Change from baseline to post-treatment (16 weeks from baseline).
Secondary outcomes (12)
Change in burden caregiver at different time points
Zarit Carer Burden Interview. Spanish Version. It´s a questionnaire that evaluates carer burden and asks about many commonly reported difficulties faced by carers (intraclass correlation coefficient = .71). This questionnaire presents 22 Likert-type questions each of which has a score of 0 to 4. The total score can be from 0 to 88. Higher values indicate greater burden caregiver.
Measured: Change from baseline to post-treatment (16 weeks from baseline).
Changes in anxiety at different time points
Goldberg Anxiety Scale. Spanish version. It´s a self-reported measure that contains 9 questions designed to assed people anxiety. Scores range from 0-9. A higher score indicates a higher level anxiety
Measured: Change from baseline to post-treatment (16 weeks from baseline).
Changes in depression
The 15-item abbreviated version of the Geriatric Depression Scale (GDS), which measures depression (internal consistency, Cronbach's α = .80). A score of 4 or more has been reported to indicate clinical signs of depression.
Measured: Change from baseline to post-treatment (16 weeks from baseline).
Change in pain assesment at different simple points
Visual analog scale (VAS). The Vas is a 100 mm long horizontal line ranging from "0: no pain at all" on one end to "100: worst pain imaginable" on the other end. Participants mara a point along the line that best represents the pain they are experiencing at that moment. A higher score indicates a higher level of pain
Measured: Change from baseline to post-treatment (16 weeks from baseline).
Change in disability
Roland-Morris Disability Questionnaire (RMDQ).Spanish version. It is a self-administered disability questionnaire consisting of 24 questions that are specifically related to physical functions that may be affected by back pain. Score range from 0-24. A higher score indicates a higher level of Disability
Measured: Change from baseline to post-treatment (16 weeks from baseline).
Modifications of body mass index
Modification of the body mass index (BMI). Wheight in Kg and Height ill be combined to report BMI in kg/m^2
Measured: Change from baseline to post-treatment (16 weeks from baseline).
Changes in handgrip strength
Handgrip strength will be assess for both hands by using a hand dynamometer (TKK 5401, Japan) and the mean value of both hands (kg*m2) is considered to be outcome.
Measured: Change from baseline to post-treatment (16 weeks from baseline).
Changes in lower extremity function
Lower extremity function is assessed by using the "30 Second chair stand test". The patient is asked to stand upright from a standardized chair (0.43 m in height) with arms folded across the chest and to sit back down as many time as he can in 30 seconds.
Measured: Change from baseline to post-treatment (16 weeks from baseline).
Changes in postural balance
Postural balance is assessed by performing a blind flamingo test in which the barefoot subject stood with eyes closed on one leg, while the other leg is flexed at knee leven al held at the anckle by the hand of the same side of the body. The number of trials that the subject needed to complete 30 seconds of the static position is measured. The outcomes is expressed as number of trials
Measured: Change from baseline to post-treatment (16 weeks from baseline)
Changes in flexibility
Flexibility is assessed by using the "Sit and reach test". Here the distance between the tips of the fingers in the start to the final positions during this trunk flexion is recorded. The best result of two trials is considered the outcome.
Measured: Change from baseline to post-treatment (16 weeks from baseline).
Changes in mobility
Mobility is assessed by using the "Timed Up and Go test". This test involves getting out of a chair, walking 3 meters to and around a cone, and returning to the chair in the shortest time possible. The best score of two trials is recorded.
Measured: Change from baseline to post-treatment (16 weeks from baseline).
Changes in maximal oxygen uptake (Vo2 max)
Maximal oxygen uptake (Vo2 max) is assessed using the "2km Walking test " We perform the test based on the guidelines of the Afisal-Inefc Battery. For this purpose, a circuit is designed, is also used stopwatch (portable digital brand Oregon Scientific®, model SL929 Hockenheim Nero) with a precision of tenths of a second (0.1 sg) and heart rate monitors (Polar RS800 CX) to measure the heart rate at the end of the test. Procedure: The caregivers with comfortable clothes and shoes walk as fast as possible they could without running. Interpretation of the results: The time used to travel is recorded 2 kilometers, the heart rate corresponding to the end of the test expressed in beats per minute. If you spend more than 22 minutes completing the this test loses its validity. To calculate de maximal oxigen uptake (Vo2 max) this formula is used: Vo2max ( mi· kg·' ·min·' ) = 116,2 - 2,98*(time) - 0,11*(heart rate) - 0,14 (age) - 0,39*( body mass index)
Measured: Change from baseline to post-treatment (16 weeks from baseline).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2018
- Study start14 Sep 2015
- Primary completion20 Jun 2016
- Study completion20 Jun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CaregiverStudies 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
- Model description
- Parallel Assignment
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundacion para la Investigacion y Formacion en Ciencias de la Salud
- Sponsor type
- University, hospital or other
- Collaborators
- Castilla-León Health Service
- Responsible party
- Sponsor
- Investigators
- Federico Montero Cuadrado, Principal investigator, Castilla-Leon Health Service
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03675217
- Sponsor's protocol ID
- GRS/VAE5-15
- Status last verified
- Aug 2018
- First submitted
- 14 Sep 2018
- Last updated
- 18 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physical Exercise Program for Family Caregivers of Dependent Patients: Randomized Clinical Trial in Primary Health Care
- ClinicalTrials.gov ID
- NCT03675217
- Acronym / sponsor ID
- GRS/VAE5-15
- Conditions
- Caregiver, Physical Activity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Fundacion para la Investigacion y Formacion en Ciencias de la SaludUniversity, hospital or other
- Collaborators
- Castilla-León Health Service
- Study start
- 14 Sep 2015 (actual)
- Primary completion
- 20 Jun 2016 (actual)
- Study completion
- 20 Jun 2016 (actual)
- First posted
- 18 Sep 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.
This estudy evaluates the effects of physical exercise program on health related quality of life (HRQoL), pain and physical fitness in family caregiver.
Detailed description
Justification: Research indicates that the dependent patient caregiver´s have physical, psychological and social repercussions, as consequence of the care that they provide. From Primary Health Care there is a "caregiver care program" to prevent and palliate this situation, consisting mainly in education programs in care and psychotherapy. There is controversy about the effectiveness of these programs, being necessary to develop new therapeutic strategies.
Objectives: to determine the effects of a physical exercise program, adressed by the primary health care physioterapist, on health related quality of life (HRQol), pain and physical fitness in dependent patient caregivers included in the " caregiver care program" of a basic health area.
Methodology: randomized clinical trial, with control group (GC = 32) and intervention group (GI = 36), double blind and pre and post-intervention evaluation. The GC received the usual program of the " caregiver care program". The GI also carried out a multi-component exercise program for 12 weeks, with 3 weekly sessions realized in group and monitored by physiotherapists. The outcomes variables are measured by Quality of life (SF-36), Burden (Zarit), anxiety (Goldberg Ansiety Questionanaire), depression (Yesavage Questionnaire), pain intensity (EVA), disability (Roland Morris) and physical fitness (battery of fitness tests). Patients evaluator and Outcomes Assessor are masked.
Applicability of results: If the physical exercise program, carried out from the primary health care physiotherapy, improves the HRQol, pain and physical fitness, this intervention could be an effective therapeutic strategy in the "caregiver care programs". Furthermore the proposed intervention is simple, reproducible and requires few resources.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Parallel Assignment
| Arm | Type | Receives |
|---|---|---|
| PE and PCFPC | Experimental | Other: PE, Other: Usual CarePhysical Exercise and primary care family caregivers program |
| Usual Care | Active comparator | Other: Usual CareUsual Care: PCFPC (primary care family caregivers program) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Status as family caregiver and to be incluided in the "Caregiver care Program".
- Provided care to family dependent al least 6 months.
- Accept to participate in the study and sign the informed consent.
- No changes in medication for at least 3 months prior to study entry.
Key exclusion criteria (4 listed)
- People whith associated pathologies that make it impossible to perform physical exercise program (moderate-intensity exercise).
- To be incluiding in other family care program
- Participation in any regular physical activity program.
- To have a formal caregiver to care for the dependent family member
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 |
|---|---|---|
| PEPhysical exercise program for familiy caregivers. 36 session physical exercise (3 sessions/week) performed by physioterapist. It incluided exercices to improve coordination, aerobic capacity, control motor and strenght | Other | PE and PCFPC |
| Usual CareUsual Programe in primary care for family caregivers. 4 session (2 session/week). It incluides: ergonomy, postural hygiene, mobilitation of patients and self-care. | Other | PE and PCFPC, Usual Care |
Primary outcome
Change in Health-related Quality of Life at different time point
Time frame: Change from baseline to post-treatment (16 weeks from baseline).
Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36) V2. Spanish version. The SF-36 is a 36- item scale constructed to survey health status and quality of life. It yields an 8-scale profile of functional health and well-being scores as well as psychometrically-based physical and mental health summary. Each scale is directly transformed into a 0-100 scale. Higher scores indicate better overall quality of life.
12 secondary outcomes
Change in burden caregiver at different time points
Time frame: Change from baseline to post-treatment (16 weeks from baseline).
Changes in anxiety at different time points
Time frame: Change from baseline to post-treatment (16 weeks from baseline).
Changes in depression
Time frame: Change from baseline to post-treatment (16 weeks from baseline).
Change in pain assesment at different simple points
Time frame: Change from baseline to post-treatment (16 weeks from baseline).
Change in disability
Time frame: Change from baseline to post-treatment (16 weeks from baseline).
Modifications of body mass index
Time frame: Change from baseline to post-treatment (16 weeks from baseline).
Changes in handgrip strength
Time frame: Change from baseline to post-treatment (16 weeks from baseline).
Changes in lower extremity function
Time frame: Change from baseline to post-treatment (16 weeks from baseline).
Changes in postural balance
Time frame: Change from baseline to post-treatment (16 weeks from baseline)
Changes in flexibility
Time frame: Change from baseline to post-treatment (16 weeks from baseline).
Changes in mobility
Time frame: Change from baseline to post-treatment (16 weeks from baseline).
Changes in maximal oxygen uptake (Vo2 max)
Time frame: Change from baseline to post-treatment (16 weeks from baseline).
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 18 Sep 2018.
- Individual participant dataSharing planned: No
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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.
Federico Montero Cuadrado principal investigator
Castilla-Leon Health Service
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PE in people with Caregiver and Physical Activity, run by Fundacion para la Investigacion y Formacion en Ciencias de la Salud 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 4 inclusion and 4 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 18 Sep 2018. 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?
Change in Health-related Quality of Life at different time point (time frame: Change from baseline to post-treatment (16 weeks from baseline).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Sep 2018.