Impact of a Multicomponent Exercise Program (VIVIFRAIL)on Functional Capacity in Frail Community Aged Participants With Cognitive Decline . Multi-center Randomized Control Trial
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Frail Elderly Syndrome
- Sponsor
- Fundacion Miguel Servet
- Enrollment
- 240
- Locations
- 1
- Primary Endpoint
- Short Physical Performance Battery (SPPB)
- Last Updated
- 7 years ago
Overview
Brief Summary
Randomized Controlled trial of 370 aged participants over 75 years old coming from clinics of Geriatric Departments in three University Hospitals in Spain (Pamplona, Getafe y San Sebastián). Participants who met inclusion criteria will be randomized to control (usual care)l or intervention group (multicomponent exercise program). The main objective of the trial is to study the effect of a multicomponent exercise training program (resistance, aerobic, strength, balance and flexibility) in frail aged participants who live in the community with cognitive decline in: functional capacity, strength, power, cognition, falls , depression, quality of life, institutionalization and hospital admissions
Detailed Description
Usual care group (control) Participants randomly assigned to the usual care group will receive normal outpatient care, which includes physical rehabilitation when needed. Intervention group (training) The intervention will consist of a multicomponent exercise training programme -VIVIFRAIL-(A Practical Guide for Prescribing a Multi-Component Physical Training Program to prevent weakness and falls in People over 70, Showed in www.vivifrail.com), which will be composed of supervised progressive resistance training, balance-training, flexibility and cardiovascular for 7 days/week. During the training period, patients will be trained between 2 and 120 minutes each day. The supervised multicomponent exercise training programme will be comprised of upper and lower body strengthening exercises, tailored to the individual's functional capacity, using dumbbells aiming for 2-3 sets of 10-15 repetitions at an intensity of 30-50% of 1RM combined with balance-training, flexibility and gait exercises that progressed in difficulty. The resistance exercises focused on the major upper and lower limb muscles. During the progressive resistance training, instruction will be provided to the participants to perform the exercises at a high velocity of motion. However, care will be taken to ensure that exercises were executed with correct form. Balance and gait training exercises that progressed in difficulty will be also implemented: e.g. semitandem foot standing, line walking, stepping practice, walking with small obstacles, proprioceptive exercises, and altering the base of support and weight transfer from one leg to the other. An experienced physical trainer will carefully explain all the exercises. Participants and their carer / family members will be carefully familiarized with the training procedures in advance.
Investigators
Eligibility Criteria
Inclusion Criteria
- •- Age: 75 years or older.
- •Able to ambulate with or without personal/technical assistance.
- •Barthel Index ≥
- •Able to communicate.
- •Mild cognitive impairment or Dementia level GDS-
- •Fragility o pre-frailty according to Linda Fried ≥
- •Subjects should have someone to help them do the exercises.
- •Informed consent: Must be capable and willing to provide consent.
Exclusion Criteria
- •Any factor precluding performance of the physical training programme or testing procedures as determined by the attending physician. These factors include, but are not limited to the following:
- •Myocardial infarction in the past 3 months.
- •Unstable Angina pectoris.
- •Terminal illness.
- •Uncontrolled arrhythmia.
- •Unstable cardiovascular disease or other medical condition.
- •Uncontrolled arterial hypertension.
Outcomes
Primary Outcomes
Short Physical Performance Battery (SPPB)
Time Frame: Changes from baseline to 1st and 3th months of follow up
The functional capacity of patients will be evaluated by the Short Physical Performance Battery (SPPB) which evaluates, balance, gait ability, and leg strength using a single tool. The total score ranges from 0 (worst) to 12 points (best). The SPPB test has been shown to be a valid instrument for screening frailty and predicting disability, institutionalization, and mortality. A total score of less than 10 indicates frailty and a high risk of disability and falls. A one-point change in the score has clinical relevance
Secondary Outcomes
- 6-metre gait velocity test (GVT).(Changes from baseline to 1st and 3th months of follow up)
- MEC-Lobo cognitive test(Changes form baseline to 1st and 3th months of follow up)
- MOCA( Montreal Cognitive Assessment) test(Changes from baseline to 1st and 3th months of follow up)
- Barthel index(Changes from baseline to 1st and 3th months of follow up)
- Handgrip strength in the dominant hand(Changes from baseline to 1st and 3th months of follow up)
- Trail Making Test part A ( TMT-A)(Changes from baseline to 1st and 3th months of follow up)
- Isometric lower limb strength test (right knee extensors and hip flexors)(Changes from baseline to 1st and 3th months of follow up)
- 1Repetition Maximum (RM) Maximal dynamic strength test(Changes from baseline to 1st and 3th months of follow up)
- Repetitions at maximal velocity at intensities of 50% of 1RM test(Changes from baseline to 1st and 3th months of follow up)
- Geriatric Depression Scale ( GDS) Yesavage abbreviated scale(Changes from baseline to 1st and 3th months of follow up)
- Categorical pain scale(Changes from baseline to and 3th months of follow up)
- Rate of falls(Baseline, 1st and 3th months of follow up)
- Vivifrail risk of falls scale(Changes from baseline to 1st and 3th months of follow up)
- Mortality(Changes from baseline to 1st and 3th months of follow up)
- Admissions to the hospital(Baseline, 1st and 3th months of follow up)
- Incidence of institutionalization to nursing homes(Baseline, 1st and 3th months of follow up)
- Visit to emergency room(Baseline, 1st and 3th months of follow up)
- Number of total Drugs(Changes from baseline to 3th month´s follow up)
- Presence of 5 or more drugs ( Polypharmacy ) registration(Changes from baseline to 3th month´s follow up)
- Psychotropic drugs (neuroleptics , cholinesterase inhibitors , antidepressants , benzodiazepines , anti-epileptics) registration(Changes from baseline to 3th month´s follow up)
- Neuropsychiatric Inventory Questionary (NPI)(Changes from baseline and 3th month´s follow up)
- Dual task gait ( arithmetic) 6 m velocity test(Changes from baseline to 1st and 3th months of follow up)
- Dual task gait (verbal) 6 m velocity test(Changes from baseline to 1st and 3th months of follow up)
- EuroQol-5D (EQ-5D) quality of life assessment test(Changes from baseline to 3th month´s follow up)
- Registration of other geriatric syndromes (visual and hear impairment, urinary and fecal incontinence, delirium , dysphagia, constipation , pressure ulcers )(Changes from baseline to 3th month´s follow up)