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

NCT ID: NCT05744492

Last Updated: 2023-02-28

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 177 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-31
• Study Completion Date: 2025-03-31

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.

Conditions

Healthy Ageing

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Supervised Vivifrail (S-ViF)

A 12-week intervention program that consists of walking every day (the time is individually adjusted) and exercising 3 times a week. Shared features of the different programs are the inclusion of resistance, cardiovascular, balance and flexibility components. All exercises will be individually tailored. Once-per-week, subjects assigned to this group will attend the primary care center to execute one of the three exercise sessions per week under the supervision of the physical therapist.

Group Type: EXPERIMENTAL

Vivifrail multicomponent exercise program

Intervention Type: OTHER

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.

Non-supervised Vivifrail Group (NS-ViF)

A 12-week intervention program that consists of walking every day (the time is individually adjusted) and exercising 3 times a week. Shared features of the different programs are the inclusion of resistance, cardiovascular, balance and flexibility components. All exercises will be individually tailored. Subjects assigned to this group will follow a domiciliary-based program and they will not attend the primary care center to execute the exercises.

Group Type: EXPERIMENTAL

Vivifrail multicomponent exercise program

Intervention Type: OTHER

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.

Control group (UCG)

Subjects will receive usual care following prevention protocols of Primary Care Services in Madrid. Concisely, the benefits of physical activity are individually explained and subjects are advised to walk as much as possible with the aim of reaching at least 30 minutes a day, 5 days a week, following the recommendations of the World Health Organization. No structured exercise-based interventions are programmed in this group.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Public Health Service of Madrid

OTHER

Sponsor Role: collaborator

European University Spain

OTHER

Sponsor Role: lead

Responsible Party

Maria-Jose Gimenez Mestre

Principal Investigator, Physical Therapy & Health Sciences Research Group, Adjunct lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Maria-Jose Gimenez, PhD

Role: PRINCIPAL_INVESTIGATOR

European University

Central Contacts

Maria-Jose Gimenez, PhD

Role: CONTACT

mariajose.gimenez@universidadeuropea.es

+34629174335

References

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.

Reference Type: BACKGROUND

PMID: 10811152 (View on PubMed)

Related Links

http://vivifrail.com/

The Vivifrail multicomponent exercise program - Home page

Other Identifiers

22/574

Identifier Type: -

Identifier Source: org_study_id