Multicomponent Exercise Program on the Intrinsic Capacity (ICOPE) of Community-dwelling Older Adults in Primary Care

European University Spain177 enrolled

Overview

A three-branch multi-center randomized clinical trial to be conducted in 6 public Primary Care centers located in the city of Madrid (Spain). A total of 180 older adults (\>=70 years old) presenting with declines in the intrinsic capacity (IC) locomotion domain will be recruited in the participating centers. They will be randomized in a 1:1:1 ratio to a center-based supervised Vivifrail multicomponent exercise (MCE) program, a home-based non-supervised Vivifrail MCE program, or to a control group. The intervention consists of thrice-a-week exercise sessions encompassing strength, aerobic, flexibility, and balance and gait training tailored to the individual's baseline functional ability. IC will be assessed through its operational domains following ICOPE guidelines at baseline and 6 and 12 weeks after the start of the intervention. Secondarily, effects on frailty status and health-related quality of life will be evaluated. This study might bring new evidence around the ICOPE recommendation on the Vivifrail MCE for the management of IC locomotion declines in Primary Care for the first time. Gaining insight on exercise interventions for IC promotion/maintenance will reinforce current recommendations and contribute to the development of real-world strategies for healthy aging promotion.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

177

Conditions

Healthy Ageing

Vivifrail multicomponent exercise programOTHER

Resistance: 3 sets of 2 repetitions of 3-4 exercises with a 1 to 3-minute break between sets. Intensity from 30-repetition maximum (RM) at weeks 1-6 to 20-RM at weeks 7-12. Balance training: both static and dynamic. Subjects will increase the number of repetitions, the difficulty of the exercises or will add external perturbations to the tasks (unstable surfaces, obstacles, or visual deprivation) along the duration of the interventions to guaranteeing progression. In the case of high risk of falling the number, frequency and volume of balance exercises will be increased. Flexibility: a set of stretching exercises at the end of each session. Subjects will be instructed to stretch until they feel tension in their muscles without reaching discomfort. Stretching will be maintained for 10 sec. and repeated 2-3 times. Cardiovascular: walking-based activities oriented to increase cardiorespiratory fitness. They will range from 5-10 sec. to 45 min/session.

Eligibility

Sex: ALLMin age: 70 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Age ≥70 years old * Attending participating primary care centers * Pre-frailty or frailty according to Fried's criteria * SPPB \<10 * Barthel Index Score ≥60 * Being able to communicate and ambulate with or without technical aids * Relative/caregiver willingness to supervise the exercise (if needed) Exclusion Criteria: * Major cognitive disorder according to the Diagnostic and Statistical Manual of Mental Disorders V criteria or the Global Deterioration Scale by Reisberg (GDS\>4) * Physically active individuals (moderate-to-vigorous physical activity greater than 150 minutes per week according current physical activity guidelines for older adults) or those already participating in structured physical exercise programs * Diagnosis of a terminal illness/life expectancy ≤3months * Lack of possibility of follow-up * Institutionalized or awaiting institutionalization * Any contraindications for physical exercise or testing procedures, including but not limited to: myocardial infarction in the past 6 months; unstable angina pectoris; uncontrolled arrhythmia; unstable cardiovascular disease or other unstable medical condition; uncontrolled arterial hypertension; recent pulmonary thromboembolism; upper or lower extremity fracture in the past 3 months

Outcomes

Primary Outcomes

Change from baseline to 12-weeks in the Short Physical Performance Battery (SPPB) score

Short Physical Performance Battery score measuring balance, lower extremity strength, and functional capacity in older adults. Minimum 0, maximum 12 (best)

Time frame: From baseline (T0) to 12-weeks (T2)

Change from baseline to 6-weeks in the Short Physical Performance Battery (SPPB) score

Short Physical Performance Battery score measuring balance, lower extremity strength, and functional capacity in older adults. Minimum 0, maximum 12 (best)

Time frame: From baseline (T0) to 6-weeks (T1)

Change from 12-weeks to 24-weeks in the Short Physical Performance Battery (SPPB) score

Short Physical Performance Battery score measuring balance, lower extremity strength, and functional capacity in older adults. Minimum 0, maximum 12 (best)

Time frame: From 12-weeks (T2) to 24-weeks (T3)

Secondary Outcomes

Change from baseline to 12-weeks in the Montreal Cognitive Assessment (MoCA) score

Cognitive function (memory, language, attention, executive function, visuospatial and orientation). Minimum 0, maximum 30 (best)

Time frame: From baseline (T0) to 12-weeks (T2)

Change from baseline to 6-weeks in the Montreal Cognitive Assessment (MoCA) score

Cognitive function (memory, language, attention, executive function, visuospatial and orientation). Minimum 0, maximum 30 (best)

Time frame: From baseline (T0) to 6-weeks (T1)

Change from 12 to 24-weeks in the Montreal Cognitive Assessment (MoCA) score

Cognitive function (memory, language, attention, executive function, visuospatial and orientation). Minimum 0, maximum 30 (best)

Time frame: From 12-weeks (T2) to 24-weeks (T3)

Change from baseline to 12-weeks in the Geriatric Depression Scale (GDS-15)

Depressive symptoms measured with the Geriatric Depression Scale (GDS-15), minimum 0, maximum 15 (worse)

Time frame: From baseline (T0) to 12-weeks (T2)

Change from baseline to 6-weeks in the Geriatric Depression Scale (GDS-15)

Depressive symptoms measured with the Geriatric Depression Scale (GDS-15), minimum 0, maximum 15 (worse)

Time frame: From baseline (T0) to 6-weeks (T1)

Change from 12-weeks to 24-weeks in the Geriatric Depression Scale (GDS-15)

Depressive symptoms measured with the Geriatric Depression Scale (GDS-15), minimum 0, maximum 15 (worse)

Time frame: From 12 weeks (T2) to 24-weeks (T3)

Change from baseline (T0) to 12-weeks (T2) in the Mini-Nutritional Assessment -Short Form (MNA-SF)

Risk of malnutrition measured with the Mini-Nutritional Assessment -Short Form (MNA-SF), minimum 0, maximum 14 (best)

Time frame: From baseline (T0) to 12-weeks (T2)

Change from baseline (T0) to 6-weeks (T1) in the Mini-Nutritional Assessment -Short Form (MNA-SF)

Risk of malnutrition measured with the Mini-Nutritional Assessment -Short Form (MNA-SF), minimum 0, maximum 14 (best)

Time frame: From baseline (T0) to 6-weeks (T1)

Change from 12-weeks (T2) to 24-weeks (T3) in the Mini-Nutritional Assessment -Short Form (MNA-SF)

Risk of malnutrition measured with the Mini-Nutritional Assessment -Short Form (MNA-SF), minimum 0, maximum 14 (best)

Time frame: From 12-weeks (T2) to 24-weeks (T3)

Change in the isometric handgrip strength from baseline (T0) to 12-weeks (T2)

Best attempt of the isometric handgrip strength (kg) of the dominant hand evaluated by a hand-held dynamometer

Time frame: From baseline (T0) to 12-weeks (T2)

Change in the isometric handgrip strength from baseline (T0) to 6-weeks (T1)

Best attempt of the isometric handgrip strength (kg) of the dominant hand evaluated by a hand-held dynamometer

Time frame: From baseline (T0) to 6-weeks (T1)

Change in the isometric handgrip strength from 12-weeks (T2) to 24-weeks (T3)

Best attempt of the isometric handgrip strength (kg) of the dominant hand evaluated by a hand-held dynamometer

Time frame: From 12-weeks (T2) to 24-weeks (T3)

Change in visual capacity from baseline (T0) to 12-weeks (T2)

Distance and near vision assessed with WHO simple eye charts

Time frame: From baseline (T0) to 12-weeks (T2)

Change in visual capacity from baseline (T0) to 6-weeks (T1)

Distance and near vision assessed with WHO simple eye charts

Time frame: From baseline (T0) to 6-weeks (T1)

Change in visual capacity from 12-weeks (T2) to 24-weeks (T3)

Distance and near vision assessed with WHO simple eye charts

Time frame: From 12-weeks (T2) to 24-weeks (T3)

Change in hearing capacity from baseline (T0) to 12-weeks (T2)

HearWHO App consisting of an automated digit-in-noise test

Time frame: From baseline (T0) to 12-weeks (T2)

Change in hearing capacity from baseline (T0) to 6-weeks (T1)

HearWHO App consisting of an automated digit-in-noise test

Time frame: From baseline (T0) to 6-weeks (T1)

Change in hearing capacity from 12-weeks (T2) to 24-weeks (T3)

HearWHO App consisting of an automated digit-in-noise test

Time frame: From 12-weeks (T2) to 24-weeks (T3)

Central Contacts

Maria-Jose Gimenez, PhD

CONTACT

+34629174335 mariajose.gimenez@universidadeuropea.es

Data from ClinicalTrials.gov

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Multicomponent Exercise Program on the Intrinsic Capacity (ICOPE) of Community-dwelling Older Adults in Primary Care

Overview

Conditions

Interventions

Eligibility

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts