Clinical trial NCT02331459: Training Intervention in a Controlled Population of Frail Elderly
Official title: Effect of a Multicomponent Training Intervention on Cognition, Mood, and Function in a Controlled Population of Community-dwelling Frail Elderly Patients.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Physical Activity
Keywords: mood
cognitive state
physical activity
frailty
Lead sponsor: Hospital de la Ribera
Sponsor class: OTHER
Collaborators: name: University of Valencia
First posted: 2015-01-06
Enrollment: 100
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: Activities of daily living.
timeFrame: Day 0 and Day 180 (plus or minus 3 days)
Secondary outcomes:
measure: Mini-Mental State Examination (MMSE)
timeFrame: Day 0 and Day 180 (plus or minus 3 days)
measure: Short Physical Performance Battery and Physical Performance Test
timeFrame: Day 0 and Day 180 (plus or minus 3 days)
Other outcomes:
measure: Geriatric Depression Scale
timeFrame: Day 0 and Day 180 (plus or minus 3 days)
measure: Quality of life: EuroQol-5D
timeFrame: Day 0 and Day 180 (plus or minus 3 days)
measure: Composite effect of a multicomponent training intervention on systemic biomarkers of frailty
timeFrame: Day 0 and Day 180 (plus or minus 3 days)
Locations:
city: Alzira
country: Spain
facility: Hospital Universitario de la Ribera
state: Valéncia
Study officials:
affiliation: Catholic University of Valencia San Vicente Mártir
name: Pilar Pérez-Ros, PhD
role: STUDY_CHAIR
affiliation: University of Valencia
name: Francisco Martínez-Arnau, PhD
role: STUDY_CHAIR
affiliation: Univeristy of Valencia
name: Jose Vina, MD,PhD
role: STUDY_DIRECTOR
affiliation: University of Valencia
name: Carmen Gómez-Cabrera, PhD
role: STUDY_CHAIR
affiliation: Hospital de la Ribera
name: Francisco J Tarazona-Santabalbina, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.