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Completed

NCT Number: NCT02331459

Training Intervention in a Controlled Population of Frail Elderly

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.

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Key information

Age range

70 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Universitario de la Ribera

Alzira, Valéncia, 46600, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • - 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.

Exclusion criteria

  • - 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.

Treatment and study plan

Multicomponent training intervention

Other

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 intervention

Other

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 outcomes

  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 outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

Hospital de la Ribera

Other

Collaborators

  • University of Valencia

Registry information

Official study title

Effect of a Multicomponent Training Intervention on Cognition, Mood, and Function in a Controlled Population of Community-dwelling Frail Elderly Patients.

Acronym: EMTIFE

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Jan 6, 2015
Registry last updated
Feb 3, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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