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

NCT05726214 | Terminated

• 1 other identifier: FragiCare exercise program
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

Frailty

Keywords

exercise; physical activity; funcionality; elderly; dwelling; socio-sanitary management

Outcome Measures

Primary Outcomes (1)

• Change from baseline Short Physical Performance Battery (SPPB) total score at 4 months

  The SPPB consists of three tasks that evaluate the lower extremities' function: balance, walking speed and sit-to-stand 5 times from a chair. In each task 0 to 4 points can be scored, to obtain a total score between 0 and 12 points. Higher values indicate better function.

  Baseline and 4 months

Secondary Outcomes (17)

• Change from baseline Fried's frailty phenotype score at 4 months

  Baseline and 6 months

• Change from baseline height at 4 months

  Baseline and 4 months

• Change from baseline weight at 4 months

  Baseline and 4 months

• Change from baseline hand grip at 4 months

  Baseline and 4 months

• Change from baseline Eight Foot up and Go (8-FUG) at 4 months

  Baseline and 4 months

Study Arms (2)

Control Group

OTHER

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

Other: Recommendations for active lifestyle

Intervention Group

EXPERIMENTAL

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.

Other: Exercise; Other: Recommendations for active lifestyle

Interventions

Exercise 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.

Intervention Group

Recommendations for active lifestyle 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.

Control Group; Intervention Group

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of the Basque Country (UPV/EHU): lead

Study Sites (1)

University of the Basque Country

Leioa, Bizkaia, 48940, Spain

Location

Related Publications (10)

• Fried LP, Tangen CM, Walston J, Newman AB, Hirsch C, Gottdiener J, Seeman T, Tracy R, Kop WJ, Burke G, McBurnie MA; Cardiovascular Health Study Collaborative Research Group. Frailty in older adults: evidence for a phenotype. J Gerontol A Biol Sci Med Sci. 2001 Mar;56(3):M146-56. doi: 10.1093/gerona/56.3.m146.

  PMID: 11253156 BACKGROUND

• Stewart A, Marfell-Jones M, International Society for Advancement of Kinanthropometry. International Standards for Anthropometric Assessment. ISAK, 2011

  BACKGROUND

• Mayordomo MM. Análisis Dinamométrico de la Mano: Valores Normativos en la Población Española. Madrid: Universidad Complutense de Madrid, Servicio de Publicaciones,; 2011

  BACKGROUND

• Rikli, R.E., Jones, C.J., 2001. Senior Fitness Test. Champaign: Human Kinetics. (ISBN 0-7360-3356-3364

  BACKGROUND

• Kaiser MJ, Bauer JM, Ramsch C, Uter W, Guigoz Y, Cederholm T, Thomas DR, Anthony P, Charlton KE, Maggio M, Tsai AC, Grathwohl D, Vellas B, Sieber CC; MNA-International Group. Validation of the Mini Nutritional Assessment short-form (MNA-SF): a practical tool for identification of nutritional status. J Nutr Health Aging. 2009 Nov;13(9):782-8. doi: 10.1007/s12603-009-0214-7.

  PMID: 19812868 BACKGROUND

• Nasreddine ZS, Phillips NA, Bedirian V, Charbonneau S, Whitehead V, Collin I, Cummings JL, Chertkow H. The Montreal Cognitive Assessment, MoCA: a brief screening tool for mild cognitive impairment. J Am Geriatr Soc. 2005 Apr;53(4):695-9. doi: 10.1111/j.1532-5415.2005.53221.x.

  PMID: 15817019 BACKGROUND

• Goldberg D, Bridges K, Duncan-Jones P, Grayson D. Detecting anxiety and depression in general medical settings. BMJ. 1988 Oct 8;297(6653):897-9. doi: 10.1136/bmj.297.6653.897.

  PMID: 3140969 BACKGROUND

• Steger MF, Frazier P, Kaler M, Oishi S. The meaning in life questionnaire: Assessing the presence of and search for meaning in life. J Couns Psychol. 2006;53(1):80-93

  BACKGROUND

• Diener E, Emmons RA, Larsen RJ, Griffin S. The Satisfaction With Life Scale. J Pers Assess. 1985 Feb;49(1):71-5. doi: 10.1207/s15327752jpa4901_13.

  PMID: 16367493 BACKGROUND

• Extremera N, Fernández-Berrocal P. The Subjective Happiness Scale: Translation and Preliminary Psychometric Evaluation of a Spanish Version. Soc Indic Res. 2014;119:473-481.

  BACKGROUND

MeSH Terms

Conditions

Frailty; Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Ana AR Rodriguez Larrad

  UPV/EHU

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate profesor

Model Details: Due to the difficulties observed during the recruitment, an allocation based on participants' will was conducted to ensure attendance. Thus, participants were allocated by convenience into two groups

Study Record Dates

• First Submitted: January 25, 2023
• First Posted: February 13, 2023
• Study Start: March 1, 2023
• Primary Completion: June 30, 2023
• Study Completion: June 30, 2023
• Last Updated: April 9, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: When data will be collected and analyzed
• Access Criteria: Data will be shared under reasonable demand to the principal investigator

Locations

ES (1)