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Training Intervention in a Controlled Population of Frail Elderly (EMTIFE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02331459
Recruitment Status : Completed
First Posted : January 6, 2015
Last Update Posted : February 3, 2015
Sponsor:
Collaborator:
University of Valencia
Information provided by (Responsible Party):
Francisco Jose Tarazona-Santabalbina, Hospital de la Ribera

Brief 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 - 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.


Condition or disease Intervention/treatment Phase
Physical Activity Other: Multicomponent training intervention Other: Nutritional intervention Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of a Multicomponent Training Intervention on Cognition, Mood, and Function in a Controlled Population of Community-dwelling Frail Elderly Patients.
Study Start Date : December 2013
Actual Primary Completion Date : January 2015
Actual Study Completion Date : January 2015

Arm Intervention/treatment
Experimental: Intervention group

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)

Other: Multicomponent training intervention

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


Other: Nutritional intervention

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)


Placebo Comparator: Control group
Normal routine during 24 weeks.
Other: Nutritional intervention

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)





Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Mini-Mental State Examination (MMSE) [ Time Frame: Day 0 and Day 180 (plus or minus 3 days) ]
    Change from baseline to the end of the intervention, and the change between the intervention group and the control group.

  2. Short Physical Performance Battery and Physical Performance Test [ Time Frame: Day 0 and Day 180 (plus or minus 3 days) ]
    Change from baseline to the end of the intervention, and the change between the intervention group and the control group.


Other Outcome Measures:
  1. Geriatric Depression Scale [ Time Frame: Day 0 and Day 180 (plus or minus 3 days) ]
    Change from baseline to the end of the intervention, and the change between the intervention group and the control group.

  2. Quality of life: EuroQol-5D [ Time Frame: Day 0 and Day 180 (plus or minus 3 days) ]
    Change from baseline to the end of the intervention, and the change between the intervention group and the control group.

  3. Composite effect of a multicomponent training intervention on systemic biomarkers of frailty [ Time Frame: Day 0 and Day 180 (plus or minus 3 days) ]
    • Plasma malondialdehyde (High performance liquid chromatography)
    • Plasma oxidized proteins (Western blotting)
    • serum interleukin (IL)-6 and tumor necrosis factor (TNF)-α (ELISA Kits)
    • Plasma GDF-11 (Western Blotting)
    • Plasma Meterorin-like (ELISA kit)



Information from the National Library of Medicine

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Ages Eligible for Study:   70 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. - Dwelling-community subjects
  2. - Age 70 years old and older
  3. Frail geriatric patient according to the Cardiovascular Health Study (CHS) Frailty Phenotype
  4. Gait speed less than 0.8 m/s.

Exclusion Criteria:

  1. - 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%)
  2. - Hospital Admission in the last 3 months for any clinical reason
  3. - oncologic patients in chemotherapy or radiotherapy active treatment
  4. - Major surgery in the last 6 months
  5. - First-degree centenary relatives in the two previous generations
  6. - Ischemic coronary event in the last 12 months
  7. Institutionalized subjects
  8. Impossibility of displacement to the Health Center by themselves.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02331459


Locations
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Spain
Hospital Universitario de la Ribera
Alzira, Valéncia, Spain, 46600
Sponsors and Collaborators
Hospital de la Ribera
University of Valencia
Investigators
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Study Chair: Pilar Pérez-Ros, PhD Catholic University of Valencia San Vicente Mártir
Study Chair: Francisco Martínez-Arnau, PhD University of Valencia
Study Director: Jose Vina, MD,PhD Univeristy of Valencia
Study Chair: Carmen Gómez-Cabrera, PhD University of Valencia
Principal Investigator: Francisco J Tarazona-Santabalbina, MD, PhD Hospital de la Ribera
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Francisco Jose Tarazona-Santabalbina, MD PhD, Hospital de la Ribera
ClinicalTrials.gov Identifier: NCT02331459    
Other Study ID Numbers: HULR-EMTIFE-2013-1
First Posted: January 6, 2015    Key Record Dates
Last Update Posted: February 3, 2015
Last Verified: January 2015
Keywords provided by Francisco Jose Tarazona-Santabalbina, Hospital de la Ribera:
mood
cognitive state
physical activity
frailty