Exercise Program for Maintaining Physical Function and Frailty on Dwelling Older Adults

NCT ID: NCT05726214

Last Updated: 2024-04-09

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-01
• Study Completion Date: 2023-06-30

Brief Summary

Older people living in their homes and receiving social assistance are at a high risk of suffering functional loss, hospitalization and/or developing disability. This condition is known as frailty. Exercise programs including strength, balance and flexibility training have demonstrated to prevent, delay or even treat frailty. However, participation in this type of exercise programs is very limited in the group of older adults mentioned above.

The present study seeks to evaluate the effects of an exercise program designed to maintain or improve physical function and frailty. The hypothesis is that people who participate in the physical exercise program will maintain or improve their physical capacity, their frailty and psycho-affective status, their quality of life, and generate a lower demand for social and health services compared to those people who do not exercise.

Detailed Description

Frailty is recognized as a syndrome that encompasses a high risk of suffering functional loss, hospitalization and/or developing dependency, among other adverse health events. It is considered a modifiable factor, capable of being reversed if intervention is made in the early stages of its development. The implementation of multicomponent physical exercise programs has been proven to prevent, delay or even treat frailty. However, participation in this type of exercise programs is very limited in older people living in their homes and receiving social assistance. Social assistance in Spain is recognized as a care and preventive nature service intended to help older adults in a situation of dependency, or risk of dependency, to remain at their homes, offering them the required domestic and personalized assistance that enables their development in their own homes and their integration into the community environment, avoiding situations of isolation. Older people living in their homes and receiving social assistance population is characterized by being particularly vulnerable, since it presents high rates of frail people that are in the initial stages of dependency, which makes them a target to significantly benefit from the effects of exercise.

The approach to tackling frailty has become a Public Health priority at a European, state and regional level, as it affects both the health and social systems in an increasingly aging society. Nevertheless, there are currently no frailty management models in an integrated manner between health and social service systems. In this context arises the FRAGICARE project, which aspires to develop a model of shared health and social management, sustainable in the long term, which promotes the permanence of the older adults in their usual social environment, respecting their lifestyles and preferences. This model is supported by a digital platform uploaded in the cellular, fed by the data collected by the professionals who are in charge of the home care service provided to the dwelling older adults. In the event of a significant change in the conditions that affect these older adults (fall, reduction in functional level, modification of the nutritional pattern, change in the social network, ...), the platform generates a series of alarms that are referred to their healthcare and/or social professional, who will reassess and, if necessary, adjust the care plan. These alarms have been defined by a multidisciplinary group of experts and piloted in a previous project. In this way, the model seeks to provide individualized, continuous and coordinated care between the basic social services system and the health system (primary and specialized care services).

The objective of the present study is to assess the effects of a physical exercise program from a multidimensional perspective, including physical function, frailty status, psycho-affective parameters, and quality of life. In addition, we will also evaluate the effect of the program in the number of alarms generated by the digital platform to the social and health services.

The hypothesis is that people who participate in the physical exercise program will maintain or improve their physical function, their frailty status, psycho-affective capacity, quality of life, and generate a lower number of social and health services alarms compared to those people who do not exercise.

Conditions

Frailty

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: TRIPLE

Study Groups

Control Group

The control group received general recommendations for maintaining physically active and reducing sedentary behaviors. This was done verbally and through written material.

Group Type: OTHER

Recommendations for active lifestyle

Intervention Type: OTHER

After the baseline assessments, all participants received individualized counseling for following physically active lifestyle and reducing sedentary behaviors. Participants were encouraged to increase the physical activity time and intensity, and to hourly break the sedentary time while at home. The recommendations were transmitted verbally and through written material.

Intervention Group

The intervention group received the same recommendations as the control group. In addition, they participated in a multicomponent physical exercise program consisting of a) 1 face-to-face weekly multicomponent session (Rodriguez-Larrad et al. BMC Geriatrics (2017)), and b) 2 autonomous sessions at home following the Vivifrail program. Our targeted duration of 24 weeks was missed due to the lack of predisposition expressed by some participants, once the recruitment was completed, to continue during summer vacation. Therefore, the intervention was restructured to be carried out in 16 weeks.

Face-to-face supervised sessions lasted 1 hour and included strength, balance, and flexibility exercises (50%-75% of the 1 repetition maximum for strength exercises). The volume, intensity and difficulty of the exercises were individualized based on the initial performance of each participant, and progressed as the participants' physical capacity evolved.

Group Type: EXPERIMENTAL

Exercise

Intervention Type: OTHER

The face-to-face multicomponent program entailed:

• Strength training of upper and lower limbs. Familiarization phase included 2-3 exercises of 1-2 series and 8-12 repetitions per session. During the acquisition phase, 2-3 exercises of 2-3 series and 8-12 repetitions at a higher velocity. The resting time between sets lasted 1-3 minutes.
• Balance exercises included proprioception, agility and weight transfer exercises. Difficulty progressively increased by reducing the base of support, by including multidirectional displacements, walking on tiptoe or heels, body-weight transfer, dynamic exercises modifying the centre of gravity, and stressing postural muscles and by sensorial reductions.
• Flexibility exercises: Static stretching maintained during 20-30s carried out at the end of each session.

The Vivifrail exercise wheel corresponding to each participant was given according to their functional level type.

Recommendations for active lifestyle

Intervention Type: OTHER

After the baseline assessments, all participants received individualized counseling for following physically active lifestyle and reducing sedentary behaviors. Participants were encouraged to increase the physical activity time and intensity, and to hourly break the sedentary time while at home. The recommendations were transmitted verbally and through written material.

Interventions

Exercise

The face-to-face multicomponent program entailed:

• Strength training of upper and lower limbs. Familiarization phase included 2-3 exercises of 1-2 series and 8-12 repetitions per session. During the acquisition phase, 2-3 exercises of 2-3 series and 8-12 repetitions at a higher velocity. The resting time between sets lasted 1-3 minutes.
• Balance exercises included proprioception, agility and weight transfer exercises. Difficulty progressively increased by reducing the base of support, by including multidirectional displacements, walking on tiptoe or heels, body-weight transfer, dynamic exercises modifying the centre of gravity, and stressing postural muscles and by sensorial reductions.
• Flexibility exercises: Static stretching maintained during 20-30s carried out at the end of each session.

The Vivifrail exercise wheel corresponding to each participant was given according to their functional level type.

Intervention Type: OTHER

Recommendations for active lifestyle

After the baseline assessments, all participants received individualized counseling for following physically active lifestyle and reducing sedentary behaviors. Participants were encouraged to increase the physical activity time and intensity, and to hourly break the sedentary time while at home. The recommendations were transmitted verbally and through written material.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 60 years or older.
• Home care users managed by the municipal social network.
• In a stable situation (no worsening, no convalescence, no hospital discharge).
• Frail or pre-frail individuals.

Exclusion Criteria

• At the end of life.
• <60 on the Barthel Index.
• Cognitive impairment that affects their decision-making ability (Mini Mental State Examination, MMSE <24).
• Subjects that, on Home Care Service's assistant's criteria, do not meet the conditions to be included in the study.

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of the Basque Country (UPV/EHU)

OTHER

Sponsor Role: lead

Responsible Party

Ana Rodriguez Larrad

Associate profesor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ana AR Rodriguez Larrad

Role: PRINCIPAL_INVESTIGATOR

UPV/EHU

Locations

University of the Basque Country

Leioa, Bizkaia, Spain

Countries

Spain

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Other Identifiers

FragiCare exercise program

Identifier Type: -

Identifier Source: org_study_id