Impact of a Multicomponent Exercise Program on Functional Capacity in Frail Aged Participants With Cognitive Decline

Cognitive Impairment Clinical Trial

Official title:

Impact of a Multicomponent Exercise Program (VIVIFRAIL)on Functional Capacity in Frail Community Aged Participants With Cognitive Decline . Multi-center Randomized Control Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03657940
• Other study ID #: Gov NA 28-16
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2017
• Est. completion date: March 2020

Study information

• Verified date: September 2018
• Source: Fundacion Miguel Servet
• Contact: Alvaro Casas Herrero, MD PhD
• Phone: +(34) 848422287
• Email: alvaro.casas.herrero[@]navarra.es
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 240
• Est. completion date: March 2020
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 75 Years and older

Eligibility

Inclusion Criteria:

• - Age: 75 years or older.

• Able to ambulate with or without personal/technical assistance.

• Barthel Index = 60.

• Able to communicate.

• Mild cognitive impairment or Dementia level GDS-4.

• Fragility o pre-frailty according to Linda Fried = 1.

• 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.

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Cognitive Impairment
• Frail Elderly Syndrome

Intervention

Behavioral:
• VIVIFRAIL multicomponent exercise training program
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 1Repetition Maximum ( combined with balance-training, flexibility and gait exercises that progressed in difficulty.

Locations

Country	Name	City	State
Spain	Fundación Miguel Servet/ Navarrabiomed	Pamplona

Sponsors (3)

Lead Sponsor	Collaborator
Fundacion Miguel Servet	Fundacion Matia, Hospital Universitario Getafe

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Mini- Nutritional Assessment (MNA)	The MNA® in the short form (MNA-SF) is a validated nutrition screening and assessment tool that can identify geriatric patients age 65 and above who are malnourished or at risk of malnutrition. Is is ranged from 0 to 14. 12-14 points indicates normal nutritional status : 8-11 points: At risk of malnutrition 0-7 points: Malnourished	Baseline visit
Other	Cumulative Illness Rating Scale for Geriatrics (CIRS-G)	This scoring system measures the chronic medical illness ("morbidity") burden while taking into consideration the severity of chronic diseases in 14 items representing individual body systems. The general rules for severity rating are: 0?No problem affecting that system.; Current mild problem or past significant problem.; Moderate disability or morbidity and/or requires first line therapy.; Severe problem and/or constant and significant disability and/or hard to control chronic problems.; Extremely severe problem and/or immediate treatment required and/or organ failure and/or severe functional impairment.; The cumulative final score can vary theoretically vary from 0 to 56 (although a very high score is impossible).	Baseline visit
Other	Functional Activities Questionnaire (FAQ)	The Functional Activities Questionnaire (FAQ) measures instrumental activities of daily living (IADLs), such as preparing balanced meals and managing personal finances. Since functional changes are noted earlier in the dementia process with IADLs that require a higher cognitive ability compared to basic activities of daily living (ADLs), this tool is useful to monitor these functional changes over time. It evaluates 10 items and it is necessary to ask informant to rate patient's ability using the following scoring system: • Dependent = 3; Requires assistance = 2; Has difficulty but does by self = 1; Normal = 0; Never did [the activity] but could do now = 0; Never did and would have difficulty now = 1 It is ranged between 0-30. Cut-point of 9 (dependent in 3 or more activities) is recommended to indicate impaired function and possible cognitive impairment.	Changes from baseline to 1st and 3th months follow up
Other	Isaacs set test	The set test is a simple rapid test of mental function which requires the subject to recall items form different common categories. In our case we choose a fluency verbal test because it´s simplicity in participants with sensorial deficits and illiteracy . We will ask the participants to say by loud in one minute words that starts with word "P". correct and wrong answers will be noted. More words indicates better cognitive function	Changes from baseline to 3th month´s follow up
Other	Gait regularity analysis with an inertial sensor unit	During functional tasks (such as balance, gait and rising form a chair ) and cognitive evaluations (dual tasking), an inertial sensor unit (IU) will be attached over the lumbar spine (L3) to record the acceleration data in control and intervention participants. Gait regularity analysis will be performed	Changes from baseline to 1st and 3th months follow up
Other	Gait cadence analysis with an inertial sensor unit	During functional tasks (such as balance, gait and rising form a chair ) and cognitive evaluations (dual tasking), an inertial sensor unit (IU) will be attached over the lumbar spine (L3) to record the acceleration data in control and intervention participants. Gait cadence analysis will be performed	Changes from baseline to 1st and 3th months follow up
Other	Gait variability analysis with an inertial sensor unit	During functional tasks (such as balance, gait and rising form a chair ) and cognitive evaluations (dual tasking), an inertial sensor unit (IU) will be attached over the lumbar spine (L3) to record the acceleration data in control and intervention participants. Gait variability analysis will be performed	Changes from baseline to 1st and 3th months follow up
Other	Gait symmetry analysis with an inertial sensor unit	During functional tasks (such as balance, gait and rising form a chair ) and cognitive evaluations (dual tasking), an inertial sensor unit (IU) will be attached over the lumbar spine (L3) to record the acceleration data in control and intervention participants. Gait symmetry analysis will be performed	Changes from baseline to 1st and 3th months follow up
Other	Five Times Sit to Stand peak power analysis test with an inertial sensor unit	During functional Five Times to Stand Test an inertial sensor unit (IU) will be attached over the lumbar spine (L3) to record the acceleration data in control and intervention participants. Peak power analysis will be performed	Changes from baseline to 1st and 3th months follow up
Other	Five Times Sit to Stand impulse analysis test with an inertial sensor unit	During functional Five Times to Stand Test an inertial sensor unit (IU) will be attached over the lumbar spine (L3) to record the acceleration data in control and intervention participants. Impulse analysis will be performed	Changes from baseline to 1st and 3th months follow up
Other	Five Times Sit to Stand orientation analysis test with an inertial sensor unit	During functional Five Times to Stand Test an inertial sensor unit (IU) will be attached over the lumbar spine (L3) to record the acceleration data in control and intervention participants. Orientation analysis will be performed	Changes from baseline to 1st and 3th months follow up
Other	Balance power spectrum analysis test with an inertial sensor unit	During functional balance assessment an inertial sensor unit (IU) will be attached over the lumbar spine (L3) to record the acceleration data in control and intervention participants. Power spectrum analysis will be performed	Changes from baseline to 1st and 3th months follow up
Other	Balance area analysis test with an inertial sensor unit	During functional balance assessment an inertial sensor unit (IU) will be attached over the lumbar spine (L3) to record the acceleration data in control and intervention participants. Balance area analysis will be performed	Changes from baseline to 1st and 3th months follow up
Primary	Short Physical Performance Battery (SPPB)	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	Changes from baseline to 1st and 3th months of follow up
Secondary	Barthel index	international and validated tool of disability. The score range from 0 (severe functional dependence) to 100 (functional independence	Changes from baseline to 1st and 3th months of follow up
Secondary	Handgrip strength in the dominant hand	Loss of handgrip strength in the dominant hand evaluated with a dynamometer is a useful tool for the measurement of functional capacity. This characteristic is a strong predictor of disability, morbidity, and mortality as well as one of the components of Fried's frailty phenotype. Higher values indicates better function Ranges of normality are corrected by BMI. For example for men with a BMI less of 24 , normality is consider over 29 kg	Changes from baseline to 1st and 3th months of follow up
Secondary	6-metre gait velocity test (GVT).	Gait ability will be assessed using the 6-metre gait velocity test (GVT). Starting and ending limits will be marked on the floor with tapelines for a total distance of 8 meters. Participants will be instructed to walk in their self-selected usual pace for two attempts. The best result of both trials will be registered. The first and last metre, considered the warm-up and deceleration phases, respectively, will not be included in calculations of the gait assessment. Higher scores ( > 1.0 m/s) indicates better functional capacity and lower scores (< 0.8 m/s) scores worse functional capacity	Changes from baseline to 1st and 3th months of follow up
Secondary	MEC-Lobo cognitive test	cognitive function will be measured will the Spanish Version of MMSE ( MEC-Lobo) in case of dementia. It ranges from 0 ( worse score ) to 35 (best score). A score less than 23 indicates significative cognitive decline	Changes form baseline to 1st and 3th months of follow up
Secondary	MOCA( Montreal Cognitive Assessment) test	cognitive function will be measured with MOCA ( Montreal Cognitive Assessment Test) in case of mild cognitive decline. The MOCA is a validated test in Spanish It ranges from 0 ( worse score ) to 30 (best score). A score less than 26 indicates suggest mild cognitive decline	Changes from baseline to 1st and 3th months of follow up
Secondary	Trail Making Test part A ( TMT-A)	Executive function will be assessed with the Trail Making Test part A. Results for TMT A are reported as the number of seconds required to complete the task; therefore, higher scores reveal greater impairment.Average will be consider 29 seconds, Deficient > 78 seconds and Rule of Thumb most 90 seconds.	Changes from baseline to 1st and 3th months of follow up
Secondary	Isometric lower limb strength test (right knee extensors and hip flexors)	Isometric lower limb (right knee extensors and hip flexors) muscle strength will be measured using a manual dynamometer. Higher values indicates better functional capacity	Changes from baseline to 1st and 3th months of follow up
Secondary	1Repetition Maximum (RM) Maximal dynamic strength test	Maximal dynamic strength will be assessed using the 1Repetition Maximum (RM) test in the bilateral leg press exercise using exercise machines (Exercycle, S.L., BH Group, Vitoria, Spain). In the first assessment, the subjects will warm up with specific movements for the exercise test. Each subject's maximal load will be determined in no more than five attempts, with a 3-min recovery period between attempts.	Changes from baseline to 1st and 3th months of follow up
Secondary	Repetitions at maximal velocity at intensities of 50% of 1RM test	Participants will perform ten repetitions at maximal velocity at intensities of 50% of 1RM to determine the maximum power (w) and the loss of power during the ten repetitions in the leg press exercise.Higher values indicates better functional capacity	Changes from baseline to 1st and 3th months of follow up
Secondary	Geriatric Depression Scale ( GDS) Yesavage abbreviated scale	Depression will be assessed wit the GDS Yesavage abbreviated scale of 15 items. Is is ranged between 0 ( best value) to 15 ( worse value). Scores between 0-5 indicates normality, 5-9 minor depression and scores over 9 indicates mayor depression	Changes from baseline to 1st and 3th months of follow up
Secondary	Categorical pain scale	Pain will be assessed with a subjective categorical pain scale. It is ranged in four categories : 0 ( no pain), 4 ( litle bit), 6 ( quite) , 10 ( a lot)	Changes from baseline to and 3th months of follow up
Secondary	Rate of falls	Rate of new falls during follow up	Baseline, 1st and 3th months of follow up
Secondary	Vivifrail risk of falls scale	Risk of falls will be assessed using Vivifrail methodology. High risk of falls is considered if one of the following questions is positive: 2 o more falls in the last year, a previous fall with medical attention and if the participant scores over 20 seconds in the time up and go test, TUG test ( time of rising from a chair, walking three meters and going back to sitting position) or less than 0.8 m/s in the Gait velocity test	Changes from baseline to 1st and 3th months of follow up
Secondary	Mortality	Mortality will be assessed with a clinical questionnaire during follow up.	Changes from baseline to 1st and 3th months of follow up
Secondary	Admissions to the hospital	New admissions to the hospital will be assessed with a clinical questionnaire during follow up	Baseline, 1st and 3th months of follow up
Secondary	Incidence of institutionalization to nursing homes	New institutionalizations to nursing homes will be assessed with clinical questionary during follow up	Baseline, 1st and 3th months of follow up
Secondary	Visit to emergency room	Visits to emergency room will be assessed with a clinical questionnaire during follow up	Baseline, 1st and 3th months of follow up
Secondary	Number of total Drugs	Number of drugs during follow up will be assessed with a clinical questionnaire	Changes from baseline to 3th month´s follow up
Secondary	Presence of 5 or more drugs ( Polypharmacy ) registration	Registration of the presence of 5 or more drugs( Polypharmacy ) during follow -up will be done with a clinical questionnaire .	Changes from baseline to 3th month´s follow up
Secondary	Psychotropic drugs (neuroleptics , cholinesterase inhibitors , antidepressants , benzodiazepines , anti-epileptics) registration	Registration of the following physchotropic drugs will be assessed with a clinical questionnaire : neuroleptics , cholinesterase inhibitors , antidepressants , benzodiazepines , anti-epileptics	Changes from baseline to 3th month´s follow up
Secondary	Neuropsychiatric Inventory Questionary (NPI)	Assessment of psycho-behavioral symptoms associated to mild cognitive decline or dementia will be assessed with the Neuropsychiatric Inventory Questionary (NPI). NPI is a validated informant-based interview that assesses 12 neuropsychiatric symptoms over the previous month.Initial responses to each domain question are "Yes" (present) or "No" (absent). If the response to the domain question is "No", the informant goes to the next question. If "Yes", the informant then rates both the Severity of the symptoms present within the last month on a 3-point scale and the associated impact of the symptom manifestations on them (i.e. Caregiver distress) using a 5-point scale. The NPI provides symptom Severity and Distress ratings for each symptom reported, and total Severity and Distress scores reflecting the sum of individual domain scores.	Changes from baseline and 3th month´s follow up
Secondary	Dual task gait ( arithmetic) 6 m velocity test	The dual-task paradigm will be used in the 6-m habitual GVT. Two trials will be conducted (best record will be taking in account) During the arithmetic dual-task condition (arithmetic GVT), we will assess gait velocity while participants are counting backward aloud from 100 by ones	Changes from baseline to 1st and 3th months of follow up
Secondary	Dual task gait (verbal) 6 m velocity test	The dual-task paradigm will be used in the 6-m habitual GVT. Two trials will be conducted(best record will be taking in account)During the verbal dual-task condition (verbal GVT), we will assess gait velocity while participants are naming animals by loud	Changes from baseline to 1st and 3th months of follow up
Secondary	EuroQol-5D (EQ-5D) quality of life assessment test	Quality of of life will be assessed with an international validated scale EuroQol-5D (EQ-5D). Its composed by. It asses health status (mobility, personal care, basic and instrumental daily living activities , pain and ansiety/depression) ranged from 0 ( worst health status) to 100 ( best health status )	Changes from baseline to 3th month´s follow up
Secondary	Registration of other geriatric syndromes (visual and hear impairment, urinary and fecal incontinence, delirium , dysphagia, constipation , pressure ulcers )	Presence of other geriatric syndromes ( visual and hear impairment, urinary and fecal incontinence, delirium , dysphagia, constipation , pressure ulcers ) will be assessed with a clinical questionnaire	Changes from baseline to 3th month´s follow up