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

Healthy Ageing Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05744492
• Other study ID #: 22/574
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 2023
• Est. completion date: March 2025

Study information

• Verified date: February 2023
• Source: European University Spain
• Contact: Maria-Jose Gimenez, PhD
• Phone: +34629174335
• Email: mariajose.gimenez[@]universidadeuropea.es
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 177
• Est. completion date: March 2025
• Est. primary completion date: March 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 70 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Healthy Ageing

Intervention

Other:
• Vivifrail multicomponent exercise program
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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
European University Spain	Public Health Service of Madrid

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	From baseline (T0) to 12-weeks (T2)
Primary	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)	From baseline (T0) to 6-weeks (T1)
Primary	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)	From 12-weeks (T2) to 24-weeks (T3)
Secondary	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)	From baseline (T0) to 12-weeks (T2)
Secondary	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)	From baseline (T0) to 6-weeks (T1)
Secondary	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)	From 12-weeks (T2) to 24-weeks (T3)
Secondary	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)	From baseline (T0) to 12-weeks (T2)
Secondary	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)	From baseline (T0) to 6-weeks (T1)
Secondary	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)	From 12 weeks (T2) to 24-weeks (T3)
Secondary	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)	From baseline (T0) to 12-weeks (T2)
Secondary	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)	From baseline (T0) to 6-weeks (T1)
Secondary	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)	From 12-weeks (T2) to 24-weeks (T3)
Secondary	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	From baseline (T0) to 12-weeks (T2)
Secondary	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	From baseline (T0) to 6-weeks (T1)
Secondary	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	From 12-weeks (T2) to 24-weeks (T3)
Secondary	Change in visual capacity from baseline (T0) to 12-weeks (T2)	Distance and near vision assessed with WHO simple eye charts	From baseline (T0) to 12-weeks (T2)
Secondary	Change in visual capacity from baseline (T0) to 6-weeks (T1)	Distance and near vision assessed with WHO simple eye charts	From baseline (T0) to 6-weeks (T1)
Secondary	Change in visual capacity from 12-weeks (T2) to 24-weeks (T3)	Distance and near vision assessed with WHO simple eye charts	From 12-weeks (T2) to 24-weeks (T3)
Secondary	Change in hearing capacity from baseline (T0) to 12-weeks (T2)	HearWHO App consisting of an automated digit-in-noise test	From baseline (T0) to 12-weeks (T2)
Secondary	Change in hearing capacity from baseline (T0) to 6-weeks (T1)	HearWHO App consisting of an automated digit-in-noise test	From baseline (T0) to 6-weeks (T1)
Secondary	Change in hearing capacity from 12-weeks (T2) to 24-weeks (T3)	HearWHO App consisting of an automated digit-in-noise test	From 12-weeks (T2) to 24-weeks (T3)

External Links

•   Integrated care for older people (ICOPE): guidance for person-centred assessment and pathways in primary care
•   The Vivifrail multicomponent exercise program - Home page