NCT02331459

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2013

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

January 3, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 6, 2015

Completed
Last Updated

February 3, 2015

Status Verified

January 1, 2015

Enrollment Period

1.1 years

First QC Date

January 3, 2015

Last Update Submit

January 31, 2015

Conditions

Physical Activity

Keywords

moodcognitive statephysical activityfrailty

Outcome Measures

Primary Outcomes (1)

  • 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)

Secondary Outcomes (2)

  • Mini-Mental State Examination (MMSE)

    Day 0 and Day 180 (plus or minus 3 days)

  • Short Physical Performance Battery and Physical Performance Test

    Day 0 and Day 180 (plus or minus 3 days)

Other Outcomes (3)

  • Geriatric Depression Scale

    Day 0 and Day 180 (plus or minus 3 days)

  • Quality of life: EuroQol-5D

    Day 0 and Day 180 (plus or minus 3 days)

  • Composite effect of a multicomponent training intervention on systemic biomarkers of frailty

    Day 0 and Day 180 (plus or minus 3 days)

Study Arms (2)

Intervention group

EXPERIMENTAL

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 interventionOther: Nutritional intervention

Control group

PLACEBO COMPARATOR

Normal routine during 24 weeks.

Other: Nutritional intervention

Interventions

Multicomponent training interventionOTHER

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

Intervention group
Nutritional interventionOTHER

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)

Control groupIntervention group

Eligibility Criteria

Age70 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • \- 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.

You may not qualify if:

  • \- 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Universitario de la Ribera

Alzira, Valéncia, 46600, Spain

Location

Related Publications (1)

  • 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.

    PMID: 26947059DERIVED

MeSH Terms

Conditions

Motor ActivityFrailty

Condition Hierarchy (Ancestors)

BehaviorPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Pilar Pérez-Ros, PhD

    Catholic University of Valencia San Vicente Mártir

    STUDY CHAIR

  • Francisco Martínez-Arnau, PhD

    University of Valencia

    STUDY CHAIR

  • Jose Vina, MD,PhD

    Univeristy of Valencia

    STUDY DIRECTOR

  • Carmen Gómez-Cabrera, PhD

    University of Valencia

    STUDY CHAIR

  • Francisco J Tarazona-Santabalbina, MD, PhD

    Hospital de la Ribera

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD PhD

Study Record Dates

First Submitted

January 3, 2015

First Posted

January 6, 2015

Study Start

December 1, 2013

Primary Completion

January 1, 2015

Study Completion

January 1, 2015

Last Updated

February 3, 2015

Record last verified: 2015-01

Locations

ES(1)