Effect of an Exercise Program for Frail Older Adults

NCT05946109 | Recruiting

• 1 other identifier: 23075_AAathome
• Study Type: interventional
• Target: 195
• Locations: 1 country
• Sites: 1

Brief Summary

Despite the high level of evidence for physical activity as a countermeasure for frailty, the current Flemish standard of care does not include structural PA interventions for community-dwelling frail older adults. One barrier for this, is the high cost of supervised physical activity programmes. Therefore, in this pragmatic randomised controlled trial, the investigators will consider the Flemish current standard of care for frail older adults as a control group. Intervention condition 1 reflects the state-of-the-art physical activity intervention provided by professionals and intervention condition 2 consists of the same intervention provided by trained volunteers. It is hypothesized that the intervention in both intervention conditions will have significant effects on functional ability, cognition, loneliness, self-management, subjective health and meaningful activities and that it can alleviate the financial burden of condition 1 (cost-effectiveness). The pretrajectory of this study was based on the 'British Medical Research Council guidance' for the development and evaluation of complex interventions. This resulted in a comprehensive, state-of-the art personalised physical activity programme for community-dwelling frail older adults: ACTIVE-AGE@home. The programme adheres to current guidelines for physical activity and exercise for frail older adults and considers low threshold and meaningful activities for the participants. The latter perfectly aligns with the complex bio-psychosocial components of frailty. Positive results will help reduce negative outcomes of frailty in older adults and will also reduce health and social expenditures. This study aligns with a 'prevention and health promotion' model.

Conditions

Frailty

Keywords

older adults; physical activity; exercise; rehabilitation; occupational therapy; health promotion; goal-oriented care; home based; primary care; geriatrics; activities of daily living; meaningful activities; cognition; loneliness; cost-effectiveness

Outcome Measures

Primary Outcomes (3)

• The Timed Chair Stand (TCS)

  The timed chair rise (TCS) is one of the most important functional evaluation clinical tests because it measures physical lower body strength and relates it to the most demanding ADLs (e.g., climbing stairs, getting out of a chair or bathtub, or rising from a horizontal position). This test is chosen based on literature data and consultancy of the experts of the research consortium. The TCR is considered a 'stress test', i.e., a test that aims to challenge the maximal physiological and/or physical capacity of the participant. It is responsive to change and influenceable via physical activity interventions, including ACTIVE-AGE@home. The test is also proven valid and reliable. In the TCR assessment, patients are asked to stand upright from a seated position in a chair (height 43 cm) with their arms folded across their chest and return to a seated position as many times as possible within a 30-s period.

  T0 = 0 weeks, prior to start of exercise program

• The Timed Chair Stand (TCS)

  The timed chair rise (TCS) is one of the most important functional evaluation clinical tests because it measures physical lower body strength and relates it to the most demanding ADLs (e.g., climbing stairs, getting out of a chair or bathtub, or rising from a horizontal position). This test is chosen based on literature data and consultancy of the experts of the research consortium. The TCR is considered a 'stress test', i.e., a test that aims to challenge the maximal physiological and/or physical capacity of the participant. It is responsive to change and influenceable via physical activity interventions, including ACTIVE-AGE@home. The test is also proven valid and reliable. In the TCR assessment, patients are asked to stand upright from a seated position in a chair (height 43 cm) with their arms folded across their chest and return to a seated position as many times as possible within a 30-s period.

  T1 = 24 weeks, at the end of the exercise program

• The Timed Chair Stand (TCS)

  The timed chair rise (TCR) is one of the most important functional evaluation clinical tests because it measures physical lower body strength and relates it to the most demanding ADLs (e.g., climbing stairs, getting out of a chair or bathtub, or rising from a horizontal position). This test is chosen based on literature data and consultancy of the experts of the research consortium. The TCR is considered a 'stress test', i.e., a test that aims to challenge the maximal physiological and/or physical capacity of the participant. It is responsive to change and influenceable via physical activity interventions, including ACTIVE-AGE@home. The test is also proven valid and reliable. In the TCR assessment, patients are asked to stand upright from a seated position in a chair (height 43 cm) with their arms folded across their chest and return to a seated position as many times as possible within a 30-s period.

  T2 = 48 weeks, follow up measurement

Secondary Outcomes (36)

• Two Minute Step Test (TMST)

  T0 = 0 weeks, prior to start of exercise program

• Two Minute Step Test (TMST)

  T1 = 24 weeks, at the end of the exercise program

• Two Minute Step Test (TMST)

  T2 = 48 weeks, follow up measurement

• The Timed Up and Go Test

  T0 = 0 weeks, prior to start of exercise program

• The Timed Up and Go Test

  T1 = 24 weeks, at the end of the exercise program

Study Arms (3)

ACTIVE-AGE@home by professionals

ACTIVE COMPARATOR

Training program of 24 weeks supervised by professionals with a relevant background in the treatment and/or training of the older adults. The older adults are trained by either a physiotherapist, an occupational therapist or an exercise professional. The professionals will receive a 3x4h training course to gain more knowledge and practice regarding following aspects: * Frailty and ageing. * Physical training principles + ACTIVE-AGE@home exercise program * Motivational coaching. All participants in the three arms will receive the same monthly newsletter with tips and tricks to obtain good health in older age.

Behavioral: ACTIVE-AGE@home

ACTIVE-AGE@home by volunteers

EXPERIMENTAL

Training program of 24 weeks supervised by volunteers who are presented by the older adults themselves or who are recruited by the research group. The older adults are trained by an informal caregiver or a newly recruited volunteer. The informal caregivers and volunteers will receive a 3x4h training course to gain more knowledge and practice regarding following aspects: * Frailty and ageing. * Physical training principles + ACTIVE-AGE@home exercise program * Motivational coaching. All participants in the three arms will receive the same monthly newsletter with tips and tricks to obtain good health in older age.

Behavioral: ACTIVE-AGE@home

Standard care for frail older adults

NO INTERVENTION

The two intervention conditions will be compared with the current standard care for frail community-dwelling elderly that does not include physical activity interventions. All participants in the three arms will receive the same monthly newsletter with tips and tricks to obtain good health in older age.

Interventions

ACTIVE-AGE@home BEHAVIORAL

functional, homebased training program offering basic functional exercises connected to meaningful activities, lifestyle coaching and motivational interviewing; derived from evidence-based training principles . Through a precise application of the FITT-VP\* guidelines, a progressive and balanced program was designed and piloted in different proof-of-concept studies. The uniqueness of the program lies in the multi-component approach which brings together functional exercises for (1) muscle strength/muscle endurance, (2) aerobic endurance, (3) flexibility, motor ability and balance and (4) meaningful daily activities, in a home-based environment. The frail participants are visited three times a week during 24 weeks with in total 72 sessions. Each session is 1 hour in duration. Thus they receive 72 training hours. \*(Frequency, Intensity, Time, Type of exercises, Volume and Progression)

Also known as: ACTIEF@thuis

ACTIVE-AGE@home by professionals; ACTIVE-AGE@home by volunteers

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• \>70 years adults
• Frail according to the frailty phenotype of Fried, defining frailty as the presence of 3 or more of the following 5 criteria: unintentional weight loss, weakness, exhaustion (low energy level), slowness (slow gait) and low physical activity

You may not qualify if:

• life expectancy less than 12 months by any cause
• oncologic participants with active treatment
• treatment with exercise therapy in the preceding 6 months
• any contra-indication for exercise therapy as established by the treating physician/family practitioner
• cognitive impairment (unable to understand the test instructions and/or Mini Mental State Examination score \<23/30)
• unable to understand the Dutch language
• diagnosed with Parkinson or Multiple Sclerosis
• having had a stroke in the preceding 6 months" to the registry

Sponsors & Collaborators

• Universitair Ziekenhuis Brussel: lead
• University Ghent: collaborator
• Universiteit Antwerpen: collaborator
• Odisee University college for applied sciences: collaborator
• Artevelde University of Applied Sciences: collaborator

Study Sites (1)

UZ Brussels

Brussels, Brussels Capital, 1090, Belgium

RECRUITING

Related Publications (18)

• Kehler DS, Theou O. The impact of physical activity and sedentary behaviors on frailty levels. Mech Ageing Dev. 2019 Jun;180:29-41. doi: 10.1016/j.mad.2019.03.004. Epub 2019 Mar 26.

  PMID: 30926562 BACKGROUND

• Negm AM, Kennedy CC, Thabane L, Veroniki AA, Adachi JD, Richardson J, Cameron ID, Giangregorio A, Petropoulou M, Alsaad SM, Alzahrani J, Maaz M, Ahmed MM, Kim E, Tehfe H, Dima R, Sabanayagam K, Hewston P, Abu Alrob H, Papaioannou A. Management of Frailty: A Systematic Review and Network Meta-analysis of Randomized Controlled Trials. J Am Med Dir Assoc. 2019 Oct;20(10):1190-1198. doi: 10.1016/j.jamda.2019.08.009.

  PMID: 31564464 BACKGROUND

• Rogers NT, Marshall A, Roberts CH, Demakakos P, Steptoe A, Scholes S. Physical activity and trajectories of frailty among older adults: Evidence from the English Longitudinal Study of Ageing. PLoS One. 2017 Feb 2;12(2):e0170878. doi: 10.1371/journal.pone.0170878. eCollection 2017.

  PMID: 28152084 BACKGROUND

• Dent E, Hoogendijk EO, Visvanathan R, Wright ORL. Malnutrition Screening and Assessment in Hospitalised Older People: a Review. J Nutr Health Aging. 2019;23(5):431-441. doi: 10.1007/s12603-019-1176-z.

  PMID: 31021360 BACKGROUND

• Luger E, Dorner TE, Haider S, Kapan A, Lackinger C, Schindler K. Effects of a Home-Based and Volunteer-Administered Physical Training, Nutritional, and Social Support Program on Malnutrition and Frailty in Older Persons: A Randomized Controlled Trial. J Am Med Dir Assoc. 2016 Jul 1;17(7):671.e9-671.e16. doi: 10.1016/j.jamda.2016.04.018.

  PMID: 27346650 BACKGROUND

• Sicsic J, Rapp T. Frailty transitions and health care use in Europe. Health Serv Res. 2019 Dec;54(6):1305-1315. doi: 10.1111/1475-6773.13208. Epub 2019 Sep 30.

  PMID: 31571222 BACKGROUND

• Mijnarends DM, Meijers JM, Halfens RJ, ter Borg S, Luiking YC, Verlaan S, Schoberer D, Cruz Jentoft AJ, van Loon LJ, Schols JM. Validity and reliability of tools to measure muscle mass, strength, and physical performance in community-dwelling older people: a systematic review. J Am Med Dir Assoc. 2013 Mar;14(3):170-8. doi: 10.1016/j.jamda.2012.10.009. Epub 2012 Dec 29.

  PMID: 23276432 BACKGROUND

• Bohannon RW, Crouch R. 1-Minute Sit-to-Stand Test: SYSTEMATIC REVIEW OF PROCEDURES, PERFORMANCE, AND CLINIMETRIC PROPERTIES. J Cardiopulm Rehabil Prev. 2019 Jan;39(1):2-8. doi: 10.1097/HCR.0000000000000336.

  PMID: 30489442 BACKGROUND

• Rikli RE, Jones CJ. Development and validation of criterion-referenced clinically relevant fitness standards for maintaining physical independence in later years. Gerontologist. 2013 Apr;53(2):255-67. doi: 10.1093/geront/gns071. Epub 2012 May 20.

  PMID: 22613940 BACKGROUND

• Singleton N, Turner A. Measuring patients' views of their health. SF 36 is suitable for elderly patients. BMJ. 1993 Jul 10;307(6896):126-7. doi: 10.1136/bmj.307.6896.126-b. No abstract available.

  PMID: 8123095 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

• Tombaugh TN. Trail Making Test A and B: normative data stratified by age and education. Arch Clin Neuropsychol. 2004 Mar;19(2):203-14. doi: 10.1016/S0887-6177(03)00039-8.

  PMID: 15010086 BACKGROUND

• Schoenberg MR, Dawson KA, Duff K, Patton D, Scott JG, Adams RL. Test performance and classification statistics for the Rey Auditory Verbal Learning Test in selected clinical samples. Arch Clin Neuropsychol. 2006 Oct;21(7):693-703. doi: 10.1016/j.acn.2006.06.010. Epub 2006 Sep 20.

  PMID: 16987634 BACKGROUND

• De Jong Gierveld J, Van Tilburg T. The De Jong Gierveld short scales for emotional and social loneliness: tested on data from 7 countries in the UN generations and gender surveys. Eur J Ageing. 2010 Jun;7(2):121-130. doi: 10.1007/s10433-010-0144-6. Epub 2010 Apr 9.

  PMID: 20730083 BACKGROUND

• Eakman AM. Measurement characteristics of the engagement in meaningful activities survey in an age-diverse sample. Am J Occup Ther. 2012 Mar-Apr;66(2):e20-9. doi: 10.5014/ajot.2012.001867.

  PMID: 22394537 BACKGROUND

• Schuurmans H, Steverink N, Frieswijk N, Buunk BP, Slaets JP, Lindenberg S. How to measure self-management abilities in older people by self-report. The development of the SMAS-30. Qual Life Res. 2005 Dec;14(10):2215-28. doi: 10.1007/s11136-005-8166-9.

  PMID: 16328901 BACKGROUND

• 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

• Vrancken D, De Smedt E, Tambeur J, De Keyser E, Vanbeuren E, Beckwee D, Lieten S, Annemans L, Peersman W, Van de Velde D, De Vriendt P. Effectiveness and cost-effectiveness of a home-based functional exercise programme for community-dwelling frail older adults, ACTIVE-AGE@home, provided by professionals and volunteers: protocol of a pragmatic randomised controlled trial. BMJ Open. 2025 Apr 7;15(4):e090746. doi: 10.1136/bmjopen-2024-090746.

  PMID: 40194869 DERIVED

Related Links

• Partner institution Artevelde University of Applied Sciences has a project page where elaborate information and tools regarding the study are available and will be posted in the future.
• Host institution VUB has a project page where basic information on the study is available.

MeSH Terms

Conditions

Frailty; Motor Activity

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• Patricia De Vriendt, Prof dr

  VUB

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Patricia De Vriendt, Prof,dr

CONTACT

+32479654110; patricia.de.vriendt@vub.be

Dimitri Vrancken, drs

CONTACT

+32 0497 46 28 87; dimitri.vrancken@vub.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: A computer algorithm will be used to generate the random allocation sequence. Participants will be randomized in a 1:1 ratio, using permuted block randomization into one of the three parallel groups. Randomization will be done centrally by an interactive web response system. Once the participants are found eligible for the trial, they can be randomized. This will generate a unique study randomization number and the treatment arm label (A professionals, B volunteers, C control) to which the participant is randomized. An accountability log with the corresponding label will be kept by the PI or delegated person to ensure that allocation was successfully performed. Participants will be scheduled to receive their randomisation within one week of eligibility assessment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof dr

Model Details: This project aims to investigate the effect on physical functioning, cognition, loneliness, self-management, subjective health and meaningful activities of frail older adults, provided by professionals (study condition 1) or provided by trained volunteers (study condition 2) or when not provided (controls, study condition 3). Since it is hypothesized that volunteers will reduce health care cost, the investigators will assess health care utilization in the three groups. Therefore, a RCT will be used.. The duration of the intervention is 24 weeks and assessments will be done before, after and at 48 weeks follow-up. The trial is designed in line with The Geriatric ICF Core Set reflecting health-related problems in community-living older adults aged 75 years and older without dementia. To limit possible bias due to non-specific treatment effects, all participants allocated to both intervention arms will receive an identical amount of treatment, securing balanced treatment arms.

Study Record Dates

• First Submitted: June 20, 2023
• First Posted: July 14, 2023
• Study Start: July 4, 2023
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): November 30, 2026
• Last Updated: December 27, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)