Study protocol of a randomised controlled trial to examine the impact of a complex intervention in pre-frail older adults

  • Ruth TehEmail author
  • Ngaire Kerse
  • Debra L. Waters
  • Leigh Hale
  • Avinesh Pillai
  • Evelingi Leilua
  • Esther Tay
  • Anna Rolleston
  • Richard Edlin
  • Eruera Maxted
  • Claire Heppenstall
  • Martin J. Connolly
Original Article



Frailty is a multidimensional geriatric syndrome associated with functional loss. The Senior Chef (SC, nutrition) and SAYGO (strength and balance exercise) programmes are well accepted among older adults but the impact of each, or a combination of both, on the frailty syndrome in pre-frail older adults is unknown.


To determine the effectiveness and cost-effectiveness of a complex intervention consisting of the SC and/or SAYGO programmes to prevent progression of frailty in pre-frail older adults.


A multi-centre randomised controlled assessor-blinded study. The four intervention groups are SC, an 8-week nutrition education and cooking class; SAYGO, a 10-week strength and balance exercise class; SC plus SAYGO, and a social group (Control). Community-dwelling adults aged 75+ (60 + Māori and Pasifika) in New Zealand are recruited through health providers. Participants are not terminally ill or with advanced dementia, and have a score of 1 or 2 on the FRAIL questionnaire. Baseline assessments are completed using standardised questionnaires prior to randomisation. Four follow-up assessments are completed: immediately after intervention, 6, 12 and 24 months post-intervention. The primary outcome is frailty score, secondary outcomes are falls, physical function, quality of life, food intake, physical activity, and sustainability of the strategy. Study outcomes will be analysed using intention-to-treat approach. Cost analyses will be completed to determine if interventions are cost effective relative to the control group.


This trial is designed to be a real world rigorous assessment of whether the two intervention strategies can prevent progression of frailty in older people. If successful, this will generate valuable information about effectiveness of this nutrition and exercise strategy, and provide insights for their implementation.

Trial registration

Australian and New Zealand Clinical Trials Registry number—ACTRN12614000827639.


Frailty Nutrition Physical activity Older adults Cost effectiveness 



We would like to acknowledge the local Primary Healthcare Organizations (East Health Trust, Manaia Health, Western Bay of Plenty, and Well South) for engaging with the general practices for the recruitment, Margaret Dando from Age Concern Otago for providing training to the SAYGO facilitators, Older Person’s Health Canterbury District Health Board for providing training to the Senior Chef facilitators, the local stakeholders (Anglican Care Whangarei, Howick Communicare, Regent Community Trust 4Cs, Senior Citizens Whangarei and local Age Concern organisations) for being instrumental in delivery of the programme, the research coordinators for assisting with the recruitment and organizing the programmes, the assessors for completing the assessments diligently, the programme facilitators for delivering the programme and transitioning to peer-led groups, and the data quality assurance personnel (Frances Backhurst).

Author contributions

RT and NK conceived the study and obtained funding for the pilot study. RT, NK, DW, LH and AP were involved in the study design and obtained funding for the main study. RT, NK, DW, LH, AP, ET, ET, AR, RE, EM and MJC contributed in writing of the manuscript. All authors read and approved the final manuscript.


The pilot study is funded by the Health Research Council New Zealand and the main study is funded by the Ageing Well Challenge, Ministry of Business Innovation and Employment. Local supermarkets (Countdown Howick and New World Whangarei) provided partial funding for the Senior Chef Programme and selected local organizations supported hall hire cost. All the funding bodies are not involved in the design of the study and collection, analysis, and interpretation of data and in writing the manuscript.

Compliance with ethical standards

Conflict of interest

The authors declare that they have no competing interests.

Ethics approval

The study is approved by the Southern Health and Disability Ethics Committee, Ministry of Health, New Zealand (Ref 14/STH/101/, 13th August 2014).

Informed consent

All participants provided written consent.

Consent for publication

Not applicable.


  1. 1.
    Clegg A, Young J, Iliffe S et al (2013) Frailty in elderly people. Lancet 381:752–762CrossRefGoogle Scholar
  2. 2.
    Campbell A, Buchner D (1997) Unstable disability and the fluctuations of frailty. Age Ageing 26:315–318CrossRefGoogle Scholar
  3. 3.
    Santos-Eggimann B, Cuenoud P, Spagnoli J et al (2009) Prevalence of frailty in middle-aged and older community-dwelling Europeans living in ten countries. J Gerontol A Biol Sci Med Sci 64:675–681CrossRefGoogle Scholar
  4. 4.
    Collard RM, Boter H, Schoevers RA et al (2012) Prevalence of frailty in community-dwelling older persons: a systematic review. J Am Geriatr Soc 60:1487–1492CrossRefGoogle Scholar
  5. 5.
    Kerse N, Teh R, Moyes S et al (2014) Māori and non-Māori in advanced age, a contrast of frailty measures. J Frailty Ageing 3:49Google Scholar
  6. 6.
    Puts MTE, Toubasi S, Andrew MK et al (2017) Interventions to prevent or reduce the level of frailty in community-dwelling older adults: a scoping review of the literature and international policies. Age Ageing 46:383–392PubMedPubMedCentralGoogle Scholar
  7. 7.
    Keller HH, Ostbye T, Goy R (2004) Nutritional risk predicts quality of life in elderly community-living Canadians. J Gerontol A Biol Sci Med Sci 59:68–74CrossRefGoogle Scholar
  8. 8.
    Kelaiditi E, van Kan GA, Cesari M (2014) Frailty: role of nutrition and exercise. Curr Opin Clin Nutr Metab Care 17:32–39PubMedGoogle Scholar
  9. 9.
    Milne AC, Potter J, Avenell A (2002) Protein and energy supplementation in elderly people at risk from malnutrition. Cochrane Database Syst Rev. 3:CD003288Google Scholar
  10. 10.
    Talegawkar SA, Bandinelli S, Bandeen-Roche K et al (2012) A higher adherence to a Mediterranean-style diet is inversely associated with the development of frailty in community-dwelling elderly men and women. J Nutr 142:2161–2166CrossRefGoogle Scholar
  11. 11.
    Erlich R, Yngve A, Wahlqvist ML (2012) Cooking as a healthy behaviour. Public Health Nutr 15:1139–1140CrossRefGoogle Scholar
  12. 12.
    Healthy eating healthy ageing team (2014) Senior Chef, cooking class for older people. Canterbury District Health Board, ChristchurchGoogle Scholar
  13. 13.
    Hallal PC, Andersen LB, Bull FC et al (2012) Global physical activity levels: surveillance progress, pitfalls, and prospects. Lancet 380:247–257CrossRefGoogle Scholar
  14. 14.
    Ministry of Health (2013) Guidelines on physical activity for older people (aged 65 years and over). Ministry of Health, Wellington. Contract No.: ISBN 978-0-478-40241-4Google Scholar
  15. 15.
    Fairhall N, Sherrington C, Clemson L et al (2011) Do exercise interventions designed to prevent falls affect participation in life roles? A systematic review and meta-analysis. Age Ageing 40:666–674CrossRefGoogle Scholar
  16. 16.
    Theou O, Stathokostas L, Roland KP et al (2011) The effectiveness of exercise interventions for the management of frailty: a systematic review. J Aging Res 2011:569194CrossRefGoogle Scholar
  17. 17.
    Kerse N, Elley CR, Robinson E et al (2005) Is physical activity counseling effective for older people? A cluster randomized, controlled trial in primary care. J Am Geriatr Soc 31:817–820Google Scholar
  18. 18.
    Kolt GS, Schofield GM, Kerse N et al (2012) Healthy steps trial: pedometer-based advice and physical activity for low-active older adults. Ann Fam Med 10:206–212CrossRefGoogle Scholar
  19. 19.
    Kolt GS, Schofield GM, Kerse N et al (2005) TeleWalk: a primary care telephone counseling trial of walking in older adults. Med Sci Sports Exerc 37:S250–S251CrossRefGoogle Scholar
  20. 20.
    Leung WW, Ashton T, Kolt GS et al (2011) Cost-effectiveness of pedometer-based versus time-based green prescriptions: the healthy steps study. Aust J Prim Health 18:204–211Google Scholar
  21. 21.
    Thomas S, Mackintosh S, Halbert J (2010) Does the ‘Otago exercise programme’ reduce mortality and falls in older adults?: a systematic review and meta-analysis. Age Ageing 39:681–687CrossRefGoogle Scholar
  22. 22.
    Waters DL, Hale LA, Robertson L et al (2011) Evaluation of a peer-led falls prevention program for older adults. Arch Phys Med Rehabil 92:1581–1586CrossRefGoogle Scholar
  23. 23.
    Wurzer B, Waters DL, Hale LA et al (2014) Long-term participation in peer-led fall prevention classes predicts lower fall incidence. Arch Phys Med Rehabil 95:1060–1066CrossRefGoogle Scholar
  24. 24.
    Robertson L, Hale B, Waters D et al (2014) Community peer-led exercise groups: reasons for success. Internet J Allied Health Sci Pract 12:1–9Google Scholar
  25. 25.
    Fried LP, Tangen CM, Walston J et al (2001) Frailty in older adults: evidence for a phenotype. J Gerontol A Biol Sci Med Sci 56:M146–M157CrossRefGoogle Scholar
  26. 26.
    Bramley D, Hebert P, Jackson R et al (2004) Indigenous disparities in disease-specific mortality, a cross-country comparison: New Zealand, Australia, Canada, and the United States. NZMJ 117:U1215Google Scholar
  27. 27.
    Statistics New Zealand (2015) New Zealand period life tables: 2012–14. Statistics New Zealand, WellingtonGoogle Scholar
  28. 28.
    Lopez D, Flicker L, Dobson A (2012) Validation of the frail scale in a cohort of older Australian women. J Am Geriatr Soc 60:171–173CrossRefGoogle Scholar
  29. 29.
    Hyde Z, Flicker L, Almeida OP et al (2010) Low free testosterone predicts frailty in older men: the health in men study. Int J Clin Endocrinol Metab 95:3165–3172CrossRefGoogle Scholar
  30. 30.
    Robertson MC, Campbell AJ, Gardner MM et al (2002) Preventing injuries in older people by preventing falls: a meta-analysis of individual-level data. J Am Geriatr Soc 50:905–911CrossRefGoogle Scholar
  31. 31.
    Cruz-Jentoft AJ, Baeyens JP, Bauer JM et al (2010) Sarcopenia: European consensus on definition and diagnosis Report of the European Working Group on Sarcopenia in Older People. Age Ageing 39:412–423CrossRefGoogle Scholar
  32. 32.
    Abellan Van Kan G, Rolland Y, Andrieu S et al (2009) Gait speed at usual pace as a predictor of adverse outcomes in community-dwelling older people an International Academy on Nutrition and Aging (IANA) task force. J Nutr Health Aging 13:881–889CrossRefGoogle Scholar
  33. 33.
    Morley J, Malmstrom TK, Miller DK (2012) A simple frailty questionnaire (FRAIL) predicts outcomes in middle aged African Americans. J Nutr Health Aging 16:601–608CrossRefGoogle Scholar
  34. 34.
    Stewart AL, Mills KM, King AC et al (2001) CHAMPS physical activity questionnaire for older adults: outcomes for interventions. Med Sci Sports Exerc 33:1126–1141CrossRefGoogle Scholar
  35. 35.
    Hekler EB, Buman MP, Haskell WL et al (2012) Reliability and validity of CHAMPS self-reported sedentary-to-vigorous intensity physical activity in older adults. J Phys Act Health 9:225CrossRefGoogle Scholar
  36. 36.
    Lamb SE, Jørstad-Stein EC, Hauer K et al (2005) Development of a common outcome data set for fall injury prevention trials: the prevention of falls network europe consensus. J Am Geriatr Soc 53:1618–1622CrossRefGoogle Scholar
  37. 37.
    Mijnarends DM, Meijers JMM, Halfens RJG et al (2013) 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 14:170–178CrossRefGoogle Scholar
  38. 38.
    Guralnik J, Ferrucci L, Simonsick E et al (1995) Lower-extremity function in persons over the age of 70 years as a predictor of subsequent disability. New Eng J Med 332:561–566CrossRefGoogle Scholar
  39. 39.
    Essink-Bot ML, Krabbe PF, Bonsel GJ et al (1997) An empirical comparison of four generic health status measures. The Nottingham Health Profile, the Medical Outcomes Study 36-item Short-Form Health Survey, the COOP/WONCA charts, and the EuroQol instrument. Med Care 35:522–537CrossRefGoogle Scholar
  40. 40.
    Yohannes AM, Roomi J, Waters K et al (1998) A comparison of the Barthel index and Nottingham extended activities of daily living scale in the assessment of disability in chronic airflow limitation in old age. Age Ageing 27:369–374CrossRefGoogle Scholar
  41. 41.
    Brazier JE, Roberts J (2004) The estimation of a preference-based measure of health from the SF-12. Med Care 42:851–859CrossRefGoogle Scholar
  42. 42.
    Bradley J, Simpson E, Poliakov I et al (2016) Comparison of INTAKE24 (an online 24-h dietary recall tool) with Interviewer-Led 24-h recall. Year-Old Nutr 8:11–24.Google Scholar
  43. 43.
    University of Otago and Ministry of Health (2011) A focus on nutrition: key findings of the 2008/09 New Zealand adult nutrition survey. Ministry of Health, WellingtonGoogle Scholar
  44. 44.
    Adamson A, Collerton J, Davies K et al (2009) Nutrition in advanced age: dietary assessment in the Newcastle 85 + study. Eur J Clin Nutr 63:S6–S18CrossRefGoogle Scholar
  45. 45.
    Wham C, Teh R, Moyes SA et al (2016) Macronutrient intake in advanced age: Te Puawaitanga o Nga Tapuwae Kia ora Tonu, Life and Living in Advanced Age: A Cohort Study in New Zealand (LiLACS NZ). Br J Nutr 116:1103–1115CrossRefGoogle Scholar
  46. 46.
    Yardley L, Beyer N, Hauer K et al (2005) Development and initial validation of the falls efficacy scale-international (FES-I). Age Ageing 34:614–619CrossRefGoogle Scholar
  47. 47.
    Trzepacz PT, Hochstetler H, Wang S et al (2015) Relationship between the montreal cognitive assessment and mini-mental state examination for assessment of mild cognitive impairment in older adults. BMC Geriatr 15:107CrossRefGoogle Scholar
  48. 48.
    D’Ath P, Katona P, Mullan E et al (1994) Screening, detection and management of depression in elderly primary care attenders: the acceptability and performance of the 15 item geriatric depression scale (GDS15) and the development of short versions. Fam Pract 11:260–266CrossRefGoogle Scholar
  49. 49.
    Cesari M, Vellas B, Hsu F-C et al (2015) A physical activity intervention to treat the frailty syndrome in older persons—results from the LIFE-P study. J Gerontol A Biol Sci Med Sci 70:216–222CrossRefGoogle Scholar
  50. 50.
    Campbell AJ, Robertson MC, Grow SJL et al (2005) Randomised controlled trial of prevention of falls in people aged ≥ 75 with severe visual impairment: the VIP trial. BMJ 331:817CrossRefGoogle Scholar
  51. 51.
    Fairhall N, Sherrington C, Lord SR et al (2014) Effect of a multifactorial, interdisciplinary intervention on risk factors for falls and fall rate in frail older people: a randomised controlled trial. Age Ageing 43:616–622CrossRefGoogle Scholar
  52. 52.
    Gobbens RJJ, van Assen MALM (2012) Frailty and its prediction of disability and health care utilization: The added value of interviews and physical measures following a self-report questionnaire. Arch Gerontol Geriatr 55:369–379CrossRefGoogle Scholar
  53. 53.
    Hajek A, Bock J-O, Saum K-U et al (2018) Frailty and healthcare costs—longitudinal results of a prospective cohort study. Age Ageing 47:233–241CrossRefGoogle Scholar
  54. 54.
    Fairhall N, Kurrle SE, Sherrington C et al (2015) Effectiveness of a multifactorial intervention on preventing development of frailty in pre-frail older people: study protocol for a randomised controlled trial. BMJ Open 5:e007091CrossRefGoogle Scholar
  55. 55.
    Landi F, Cesari M, Calvani R et al (2017) The “Sarcopenia and Physical frailty in older people: multi-component treatment strategies” (SPRINTT) randomized controlled trial: design and methods. Aging Clin Exp Res 29:89–100CrossRefGoogle Scholar
  56. 56.
    Nordin Olsson I, Runnamo R, Engfeldt P (2011) Medication quality and quality of life in the elderly, a cohort study. Health Qual Life Outcomes 9:95CrossRefGoogle Scholar
  57. 57.
    Applegate WB, Curb JD (1990) Designing and executing randomized clinical trials involving elderly persons. J Am Geriatr Soc 38:943–950CrossRefGoogle Scholar
  58. 58.
    McLean C, Kerse N, Moyes SA et al (2014) Recruiting older people for research through general practice: the brief risk identification geriatric health tool trial. Australas J Ageing 33:257–263CrossRefGoogle Scholar

Copyright information

© Springer Nature Switzerland AG 2019

Authors and Affiliations

  • Ruth Teh
    • 1
    Email author
  • Ngaire Kerse
    • 2
  • Debra L. Waters
    • 3
  • Leigh Hale
    • 4
  • Avinesh Pillai
    • 5
  • Evelingi Leilua
    • 1
  • Esther Tay
    • 1
  • Anna Rolleston
    • 6
  • Richard Edlin
    • 7
  • Eruera Maxted
    • 8
  • Claire Heppenstall
    • 9
  • Martin J. Connolly
    • 10
    • 11
  1. 1.Department of General Practice and Primary Health Care, School of Population HealthUniversity of AucklandAucklandNew Zealand
  2. 2.School of Population HealthUniversity of AucklandAucklandNew Zealand
  3. 3.Department of Medicine, School of PhysiotherapyUniversity of OtagoDunedinNew Zealand
  4. 4.Centre for Health, Activity and Rehabilitation Research, School of PhysiotherapyUniversity of OtagoDunedinNew Zealand
  5. 5.Department of Statistics, Faculty of ScienceUniversity of AucklandAucklandNew Zealand
  6. 6.The Centre of HealthTaurangaNew Zealand
  7. 7.Health Systems Group, School of Population HealthUniversity of AucklandAucklandNew Zealand
  8. 8.Lakes District Health BoardRotoruaNew Zealand
  9. 9.Department of MedicineUniversity of OtagoChristchurchNew Zealand
  10. 10.Department of Geriatric MedicineUniversity of AucklandAucklandNew Zealand
  11. 11.Waitemata District Health BoardAucklandNew Zealand

Personalised recommendations