Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

Tracking Information
First Submitted Date  ICMJE January 3, 2015
First Posted Date  ICMJE January 6, 2015
Last Update Posted Date February 3, 2015
Study Start Date  ICMJE December 2013
Actual Primary Completion Date January 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 5, 2015)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 5, 2015)
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: January 5, 2015)
  • 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.
  • 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.
  • 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)
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Training Intervention in a Controlled Population of Frail Elderly
Official Title  ICMJE Effect of a Multicomponent Training Intervention on Cognition, Mood, and Function in a Controlled Population of Community-dwelling Frail Elderly Patients.
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.

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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Physical Activity
Intervention  ICMJE
  • 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)

Study Arms  ICMJE
  • 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)

    Interventions:
    • Other: Multicomponent training intervention
    • Other: Nutritional intervention
  • Placebo Comparator: Control group
    Normal routine during 24 weeks.
    Intervention: Other: Nutritional intervention
Publications * Tarazona-Santabalbina FJ, Gómez-Cabrera MC, Pérez-Ros P, Martínez-Arnau FM, Cabo H, Tsaparas K, Salvador-Pascual A, Rodriguez-Mañas L, Viña 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 5, 2015)
100
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 2015
Actual Primary Completion Date January 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 70 Years and older   (Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02331459
Other Study ID Numbers  ICMJE HULR-EMTIFE-2013-1
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Francisco Jose Tarazona-Santabalbina, Hospital de la Ribera
Study Sponsor  ICMJE Hospital de la Ribera
Collaborators  ICMJE University of Valencia
Investigators  ICMJE
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
PRS Account Hospital de la Ribera
Verification Date January 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP