Physical ActivityEMTIFENCT02331459
Training Intervention in a Controlled Population of Frail Elderly
A study testing Multicomponent training intervention and Nutritional intervention in people with Physical Activity, run by Hospital de la Ribera at 1 site in Spain.
Trial summary
Exercise has a beneficial role in geriatric patients categorized as frail. Nevertheless, it is not known physical training pattern more beneficial for these patients. The reasons for heterogeneity and lack of consistency of the results described by published intervention programs may be the diversity of isolated … Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Physical Activity
- What is being tested?
- Multicomponent training intervention and Nutritional intervention
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteSpain
- Study dates
- Dec 2013to Jan 2015
- 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 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- - Dwelling-community subjects
- - Age 70 years old and older
- Frail geriatric patient according to the Cardiovascular Health Study (CHS) Frailty Phenotype
- Gait speed less than 0.8 m/s.
Who cannot join
- - Life expectancy less than 6 months for any clinical reason (we considered criteria of a life expectancy less than 6 months 7 c-7 d global deterioration degree on GDS (Global Deterioration Scale)-FAST (Functional Assessment Staging ) scale in patients with dementia; severe disabilities considered as score less than 15 points in Barthel index and left ventricular ejection fraction equal or less than 20%)
- - Hospital Admission in the last 3 months for any clinical reason
- - oncologic patients in chemotherapy or radiotherapy active treatment
- - Major surgery in the last 6 months
- - First-degree centenary relatives in the two previous generations
- - Ischemic coronary event in the last 12 months
- Institutionalized subjects
- Impossibility of displacement to the Health Center by themselves.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of a Multicomponent Training Intervention on Cognition, Mood, and Function in a Controlled Population of Community-dwelling Frail Elderly Patients.
Exercise has a beneficial role in geriatric patients categorized as frail. Nevertheless, it is not known physical training pattern more beneficial for these patients. The reasons for heterogeneity and lack of consistency of the results described by published intervention programs may be the diversity of isolated - resistance, endurance or proprioceptive trainings - or a combination of them. There are no studies with a combined program of this three kinds of physical training.
The objective of this study is to know if a multicomponent physical training program during 180 days in dwelling-community frail geriatric patients can improve scores on functional, activities of daily living, mood, cognitive and quality of life scales and producing changes in blood levels of biological and genetic markers.
Read the detailed description
At the start of recruitment, a comprehensive geriatric assessment will be developed in enrolled patients of both groups. After this assessment and before starting the physical training in intervention group, a nutritional intervention will be provided in patients of both groups :
Enrolled patients will receive nutritional information on optimal daily energy intake, ensuring at least a daily protein intake of 1 g. of by kg of weight.
As well as, calcium and vitamin D will be provided if calcidiol blood levels are lower than 30 ng/ml.
Calcidiol blood value between 20-29 ng/dl it will provide calcium + vitamin D (total amount 1200 mg calcium plus 800 IU of vitamin D) daily and calciferol 20.000 IU every 15 days (3 months)
Calcidiol blood value between 10-19 ng/dl it will provide calcium + vitamin D (total amount 1200 mg calcium plus 800 IU of vitamin D) daily and calciferol 20.000 IU every 10 days (3 months)
Calcidiol blood value between 1-9 ng/dl it will provide calcium + vitamin D (total amount 1200 mg calcium plus 800 IU of vitamin D) daily and calciferol 20.000 IU every 7 days (3 months)
After nutritional intervention, intervention group will start a multicomponent training intervention during 180 days Intervention characteristics: 24weeks, 5days/week, 60min/session Day 1, 3 and 5 15 min (a) 40 min (b) 5 min (d) Day 2 and 4 15 min (a) 40 min (c) 5 min (d)
Legend:
min. =minutes a = Proprioception exercises, postural sway and dynamic balance, coordination and flexibility of the lumbo-pelvic area b = Aerobic training 65% HRmax c = Strength training arms and legs d = Stretching Characteristics of the strength training Month 1 Week 1 25% 1-RM 1x30 r Week 2 25% 1-RM 2x30 r Week 3-4 25% 1-RM 3x30 r Month 2 Week 1-4 25% 1-RM 3x30 r Month 3 Week 1 50% 1-RM 1x15 r Week 2 50% 1-RM 2x10 r Week 3-4 50% 1-RM 3x8 r Month 4 Week 1-4 50% 1-RM 3x8 r Month 5 Week 1 75% 1-RM 1x15 r Week 2 75% 1-RM 2x10 r Week 3-4 75% 1-RM 3x8 r Month 6 Week 1-4 75% 1-RM 3x8 r
Legend:
1-RM: One-repetition maximum r: repetitions
Monthly, enrolled frail elderly patients will be evaluated. 6 minutes walking test, timed up and go test, bilateral hand grip, Barthel index, Tinetti balance assessment tool, Mini-mental state examination, short-MNA (Mini Nutritional Assessment ), lean and fat mass measures with impedanciometer and number of visits to general practitioner, emergency room and hospital admission were recorded.
After follow up period a new comprehensive geriatric assessment will be recorded.
- Conditions
- Physical Activity
- Being tested
- Multicomponent training intervention, Nutritional intervention
- Keywords
- mood, cognitive state, physical activity, frailty
- Medical subject headings
- Motor Activity, Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multicomponent training interventionOther
Intervention characteristics: 24weeks, 5days/week, 60min/session Day 1, 3 and 5 15 min (a) 40 min (b) 5 min (d) Day 2 and 4 15 min (a) 40 min (c) 5 min (d)
Legend:
min. =minutes a = Proprioception exercises, postural sway and dynamic balance, coordination and flexibility of the lumbo-pelvic area b = Aerobic training 65% maximal Heart rate c = Strength training arms and legs d = Stretching
Nutritional interventionOther
Enrolled patients will receive nutritional information on optimal daily energy intake, ensuring at least a daily protein intake of 1 g. of by kg of weight.
Calcium plus vitamin D (total amount 1200 mg calcium plus 800 IU of vitamin D) Vitamin D will be provided if calcidiol (Cldl) blood levels are lower than 30 ng/ml.
Cldl 20-29 ng/dl it will provide calciferol 20.000 IU every 15 days (3 months) Cldl 10-19 ng/dl it will provide calciferol 20.000 IU every 10 days (3 months) Cldl 1-9 ng/dl it will provide calciferol 20.000 IU every 7 days (3 months)
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Multicomponent training intervention :
3 sessions a week of 45 minutes of resistance activity (24 weeks) 2 sessions a week of 45 minutes of strength training (24 weeks) 5 sessions a week of 15 minutes of proprioceptive training (24 weeks) Receives: Other: Multicomponent training intervention; Other: Nutritional intervention |
| Control group | Placebo comparator | Normal routine during 24 weeks. Receives: Other: Nutritional intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Activities of daily living.
The primary study endpoint is the change from baseline to the end of the intervention, and the change between the intervention group and the control group, in score of Barthel Activities of Daily Living Index and the Lawton Instrumental Activities of Daily Living Scale
Measured: Day 0 and Day 180 (plus or minus 3 days)
Secondary outcomes (2)
Mini-Mental State Examination (MMSE)
Change from baseline to the end of the intervention, and the change between the intervention group and the control group.
Measured: Day 0 and Day 180 (plus or minus 3 days)
Short Physical Performance Battery and Physical Performance Test
Change from baseline to the end of the intervention, and the change between the intervention group and the control group.
Measured: Day 0 and Day 180 (plus or minus 3 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2015 (estimated)
- Study startDec 2013
- Primary completionJan 2015
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Physical ActivityStudies 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
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital de la Ribera
- Sponsor type
- University, hospital or other
- Collaborators
- University of Valencia
- Responsible party
- Principal investigator, Francisco Jose Tarazona-Santabalbina, Hospital de la Ribera
- Investigators
- Pilar Pérez-Ros, PhD, Study chair, Catholic University of Valencia San Vicente MártirFrancisco Martínez-Arnau, PhD, Study chair, University of ValenciaJose Vina, MD,PhD, Study director, Univeristy of ValenciaCarmen Gómez-Cabrera, PhD, Study chair, University of ValenciaFrancisco J Tarazona-Santabalbina, MD, PhD, Principal investigator, Hospital de la Ribera
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02331459
- Sponsor's protocol ID
- HULR-EMTIFE-2013-1
- Acronym
- EMTIFE
- Status last verified
- Jan 2015
- First submitted
- 3 Jan 2015
- Last updated
- 3 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Tarazona-Santabalbina FJ, Gomez-Cabrera MC, Perez-Ros P, Martinez-Arnau FM, Cabo H, Tsaparas K, Salvador-Pascual A, Rodriguez-Manas L, Vina J. A Multicomponent Exercise Intervention that Reverses Frailty and Improves Cognition, Emotion, and Social Networking in the Community-Dwelling Frail Elderly: A Randomized Clinical Trial. J Am Med Dir Assoc. 2016 May 1;17(5):426-33. doi: 10.1016/j.jamda.2016.01.019. Epub 2016 Mar 3.
PubMed 26947059
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Multicomponent Training Intervention on Cognition, Mood, and Function in a Controlled Population of Community-dwelling Frail Elderly Patients.
- ClinicalTrials.gov ID
- NCT02331459
- Acronym / sponsor ID
- EMTIFE / HULR-EMTIFE-2013-1
- Conditions
- Physical Activity
- Keywords
- mood, cognitive state, physical activity, frailty
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Hospital de la RiberaUniversity, hospital or other
- Collaborators
- University of Valencia
- Study start
- Dec 2013
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 6 Jan 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.
Exercise has a beneficial role in geriatric patients categorized as frail. Nevertheless, it is not known physical training pattern more beneficial for these patients. The reasons for heterogeneity and lack of consistency of the results described by published intervention programs may be the diversity of isolated - resistance, endurance or proprioceptive trainings - or a combination of them. There are no studies with a combined program of this three kinds of physical training.
The objective of this study is to know if a multicomponent physical training program during 180 days in dwelling-community frail geriatric patients can improve scores on functional, activities of daily living, mood, cognitive and quality of life scales and producing changes in blood levels of biological and genetic markers.
Detailed description
At the start of recruitment, a comprehensive geriatric assessment will be developed in enrolled patients of both groups. After this assessment and before starting the physical training in intervention group, a nutritional intervention will be provided in patients of both groups :
Enrolled patients will receive nutritional information on optimal daily energy intake, ensuring at least a daily protein intake of 1 g. of by kg of weight.
As well as, calcium and vitamin D will be provided if calcidiol blood levels are lower than 30 ng/ml.
Calcidiol blood value between 20-29 ng/dl it will provide calcium + vitamin D (total amount 1200 mg calcium plus 800 IU of vitamin D) daily and calciferol 20.000 IU every 15 days (3 months)
Calcidiol blood value between 10-19 ng/dl it will provide calcium + vitamin D (total amount 1200 mg calcium plus 800 IU of vitamin D) daily and calciferol 20.000 IU every 10 days (3 months)
Calcidiol blood value between 1-9 ng/dl it will provide calcium + vitamin D (total amount 1200 mg calcium plus 800 IU of vitamin D) daily and calciferol 20.000 IU every 7 days (3 months)
After nutritional intervention, intervention group will start a multicomponent training intervention during 180 days Intervention characteristics: 24weeks, 5days/week, 60min/session Day 1, 3 and 5 15 min (a) 40 min (b) 5 min (d) Day 2 and 4 15 min (a) 40 min (c) 5 min (d)
Legend:
min. =minutes a = Proprioception exercises, postural sway and dynamic balance, coordination and flexibility of the lumbo-pelvic area b = Aerobic training 65% HRmax c = Strength training arms and legs d = Stretching Characteristics of the strength training Month 1 Week 1 25% 1-RM 1x30 r Week 2 25% 1-RM 2x30 r Week 3-4 25% 1-RM 3x30 r Month 2 Week 1-4 25% 1-RM 3x30 r Month 3 Week 1 50% 1-RM 1x15 r Week 2 50% 1-RM 2x10 r Week 3-4 50% 1-RM 3x8 r Month 4 Week 1-4 50% 1-RM 3x8 r Month 5 Week 1 75% 1-RM 1x15 r Week 2 75% 1-RM 2x10 r Week 3-4 75% 1-RM 3x8 r Month 6 Week 1-4 75% 1-RM 3x8 r
Legend:
1-RM: One-repetition maximum r: repetitions
Monthly, enrolled frail elderly patients will be evaluated. 6 minutes walking test, timed up and go test, bilateral hand grip, Barthel index, Tinetti balance assessment tool, Mini-mental state examination, short-MNA (Mini Nutritional Assessment ), lean and fat mass measures with impedanciometer and number of visits to general practitioner, emergency room and hospital admission were recorded.
After follow up period a new comprehensive geriatric assessment will be recorded.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: Multicomponent training intervention, Other: Nutritional interventionMulticomponent training intervention : 3 sessions a week of 45 minutes of resistance activity (24 weeks) 2 sessions a week of 45 minutes of strength training (24 weeks) 5 sessions a week of 15 minutes of proprioceptive training (24 weeks) |
| Control group | Placebo comparator | Other: Nutritional interventionNormal routine during 24 weeks. |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- - Dwelling-community subjects
- - Age 70 years old and older
- Frail geriatric patient according to the Cardiovascular Health Study (CHS) Frailty Phenotype
- Gait speed less than 0.8 m/s.
Key exclusion criteria (8 listed)
- - Life expectancy less than 6 months for any clinical reason (we considered criteria of a life expectancy less than 6 months 7 c-7 d global deterioration degree on GDS (Global Deterioration Scale)-FAST (Functional Assessment Staging ) scale in patients with dementia; severe disabilities considered as score less than 15 points in Barthel index and left ventricular ejection fraction equal or less than 20%)
- - Hospital Admission in the last 3 months for any clinical reason
- - oncologic patients in chemotherapy or radiotherapy active treatment
- - Major surgery in the last 6 months
- - First-degree centenary relatives in the two previous generations
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 |
|---|---|---|
| Multicomponent training interventionIntervention characteristics: 24weeks, 5days/week, 60min/session Day 1, 3 and 5 15 min (a) 40 min (b) 5 min (d) Day 2 and 4 15 min (a) 40 min (c) 5 min (d) Legend: min. =minutes a = Proprioception exercises, postural sway and dynamic balance, coordination and flexibility of the lumbo-pelvic area b = Aerobic training 65% maximal Heart rate c = Strength training arms and legs d = Stretching | Other | Intervention group |
| Nutritional interventionEnrolled patients will receive nutritional information on optimal daily energy intake, ensuring at least a daily protein intake of 1 g. of by kg of weight. Calcium plus vitamin D (total amount 1200 mg calcium plus 800 IU of vitamin D) Vitamin D will be provided if calcidiol (Cldl) blood levels are lower than 30 ng/ml. Cldl 20-29 ng/dl it will provide calciferol 20.000 IU every 15 days (3 months) Cldl 10-19 ng/dl it will provide calciferol 20.000 IU every 10 days (3 months) Cldl 1-9 ng/dl it will provide calciferol 20.000 IU every 7 days (3 months) | Other | Control group, Intervention group |
Primary outcome
Activities of daily living.
Time frame: Day 0 and Day 180 (plus or minus 3 days)
The primary study endpoint is the change from baseline to the end of the intervention, and the change between the intervention group and the control group, in score of Barthel Activities of Daily Living Index and the Lawton Instrumental Activities of Daily Living Scale
2 secondary outcomes
Mini-Mental State Examination (MMSE)
Time frame: Day 0 and Day 180 (plus or minus 3 days)
Short Physical Performance Battery and Physical Performance Test
Time frame: Day 0 and Day 180 (plus or minus 3 days)
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 3 Feb 2015.
- Derived from this study: PubMed 26947059Tarazona-Santabalbina FJ, Gomez-Cabrera MC, Perez-Ros P, Martinez-Arnau FM, Cabo H, Tsaparas K, Salvador-Pascual A, Rodriguez-Manas L, Vina J. A Multicomponent Exercise Intervention that Reverses Frailty and Improves Cognition, Emotion, and Social Networking in the Community-Dwelling Frail Elderly: A Randomized Clinical Trial. J Am Med Dir Assoc. 2016 May 1;17(5):426-33. doi: 10.1016/j.jamda.2016.01.019. Epub 2016 Mar 3.
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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.
Pilar Pérez-Ros, PhD study chair
Catholic University of Valencia San Vicente Mártir
Francisco Martínez-Arnau, PhD study chair
University of Valencia
Jose Vina, MD,PhD study director
Univeristy of Valencia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multicomponent training intervention and Nutritional intervention in people with Physical Activity, run by Hospital de la Ribera 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 8 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 3 Feb 2015. 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. Some participants in this study may receive a placebo. 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?
Activities of daily living. (time frame: Day 0 and Day 180 (plus or minus 3 days)). 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 NCT02331459, which also lists 1 linked publication.
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 3 Feb 2015.