Training Intervention in a Controlled Population of Frail Elderly

Physical Activity Clinical Trial

— EMTIFE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02331459
• Other study ID #: HULR-EMTIFE-2013-1
• Status: Completed
• Phase: N/A
• First received: January 3, 2015
• Last updated: January 31, 2015
• Start date: December 2013
• Est. completion date: January 2015

Study information

• Verified date: January 2015
• Source: Hospital de la Ribera
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ethics Committee
• Study type: Interventional

Clinical 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 - 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: January 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 70 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Physical Activity

Intervention

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
• 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)

Locations

Country	Name	City	State
Spain	Hospital Universitario de la Ribera	Alzira	Valéncia

Sponsors (2)

Lead Sponsor	Collaborator
Hospital de la Ribera	University of Valencia

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Geriatric Depression Scale	Change from baseline to the end of the intervention, and the change between the intervention group and the control group.	Day 0 and Day 180 (plus or minus 3 days)	Yes
Other	Quality of life: EuroQol-5D	Change from baseline to the end of the intervention, and the change between the intervention group and the control group.	Day 0 and Day 180 (plus or minus 3 days)	Yes
Other	Composite effect of a multicomponent training intervention on systemic biomarkers of frailty	Plasma malondialdehyde (High performance liquid chromatography); Plasma oxidized proteins (Western blotting); serum interleukin (IL)-6 and tumor necrosis factor (TNF)-a (ELISA Kits); Plasma GDF-11 (Western Blotting); Plasma Meterorin-like (ELISA kit)	Day 0 and Day 180 (plus or minus 3 days)	Yes
Primary	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	Day 0 and Day 180 (plus or minus 3 days)	Yes
Secondary	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.	Day 0 and Day 180 (plus or minus 3 days)	Yes
Secondary	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.	Day 0 and Day 180 (plus or minus 3 days)	Yes