Clinical trial NCT05744492: Multicomponent Exercise Program on the Intrinsic Capacity (ICOPE) of Community-dwelling Older Adults in Primary Care
Official title: Effects of a Multicomponent Exercise Program on the Intrinsic Capacity of Community-dwelling Older Adults Under the ICOPE Framework: Study Protocol for a Multi-center Randomized Control Trial in Primary Care
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Healthy Ageing
Keywords: Frail Older Adults
Elderly
Primary care
Physical Therapy
Lead sponsor: European University Spain
Sponsor class: OTHER
Collaborators: name: Public Health Service of Madrid
First posted: 2023-02-27
Enrollment: 177
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Three-branch multi-center randomized clinical trial with 1:1:1 allocation to a center-based supervised Vivifrail MCE, a home-based non-supervised Vivifrail MCE program, or to a control group.
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline to 12-weeks in the Short Physical Performance Battery (SPPB) score
timeFrame: From baseline (T0) to 12-weeks (T2)
measure: Change from baseline to 6-weeks in the Short Physical Performance Battery (SPPB) score
timeFrame: From baseline (T0) to 6-weeks (T1)
measure: Change from 12-weeks to 24-weeks in the Short Physical Performance Battery (SPPB) score
timeFrame: From 12-weeks (T2) to 24-weeks (T3)
Secondary outcomes:
measure: Change from baseline to 12-weeks in the Montreal Cognitive Assessment (MoCA) score
timeFrame: From baseline (T0) to 12-weeks (T2)
measure: Change from baseline to 6-weeks in the Montreal Cognitive Assessment (MoCA) score
timeFrame: From baseline (T0) to 6-weeks (T1)
measure: Change from 12 to 24-weeks in the Montreal Cognitive Assessment (MoCA) score
timeFrame: From 12-weeks (T2) to 24-weeks (T3)
measure: Change from baseline to 12-weeks in the Geriatric Depression Scale (GDS-15)
timeFrame: From baseline (T0) to 12-weeks (T2)
measure: Change from baseline to 6-weeks in the Geriatric Depression Scale (GDS-15)
timeFrame: From baseline (T0) to 6-weeks (T1)
measure: Change from 12-weeks to 24-weeks in the Geriatric Depression Scale (GDS-15)
timeFrame: From 12 weeks (T2) to 24-weeks (T3)
measure: Change from baseline (T0) to 12-weeks (T2) in the Mini-Nutritional Assessment -Short Form (MNA-SF)
timeFrame: From baseline (T0) to 12-weeks (T2)
measure: Change from baseline (T0) to 6-weeks (T1) in the Mini-Nutritional Assessment -Short Form (MNA-SF)
timeFrame: From baseline (T0) to 6-weeks (T1)
measure: Change from 12-weeks (T2) to 24-weeks (T3) in the Mini-Nutritional Assessment -Short Form (MNA-SF)
timeFrame: From 12-weeks (T2) to 24-weeks (T3)
measure: Change in the isometric handgrip strength from baseline (T0) to 12-weeks (T2)
timeFrame: From baseline (T0) to 12-weeks (T2)
measure: Change in the isometric handgrip strength from baseline (T0) to 6-weeks (T1)
timeFrame: From baseline (T0) to 6-weeks (T1)
measure: Change in the isometric handgrip strength from 12-weeks (T2) to 24-weeks (T3)
timeFrame: From 12-weeks (T2) to 24-weeks (T3)
measure: Change in visual capacity from baseline (T0) to 12-weeks (T2)
timeFrame: From baseline (T0) to 12-weeks (T2)
measure: Change in visual capacity from baseline (T0) to 6-weeks (T1)
timeFrame: From baseline (T0) to 6-weeks (T1)
measure: Change in visual capacity from 12-weeks (T2) to 24-weeks (T3)
timeFrame: From 12-weeks (T2) to 24-weeks (T3)
measure: Change in hearing capacity from baseline (T0) to 12-weeks (T2)
timeFrame: From baseline (T0) to 12-weeks (T2)
measure: Change in hearing capacity from baseline (T0) to 6-weeks (T1)
timeFrame: From baseline (T0) to 6-weeks (T1)
measure: Change in hearing capacity from 12-weeks (T2) to 24-weeks (T3)
timeFrame: From 12-weeks (T2) to 24-weeks (T3)
Other outcomes:
Locations:
Study officials:
affiliation: European University
name: Maria-Jose Gimenez, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Guralnik JM, Ferrucci L, Pieper CF, Leveille SG, Markides KS, Ostir GV, Studenski S, Berkman LF, Wallace RB. Lower extremity function and subsequent disability: consistency across studies, predictive models, and value of gait speed alone compared with the short physical performance battery. J Gerontol A Biol Sci Med Sci. 2000 Apr;55(4):M221-31. doi: 10.1093/gerona/55.4.m221.