FrailtyNCT03824106
Frailty Rehabilitation
A study testing Group Exercise, Nutrition and Medication review and Protein Supplement in people with Frailty, run by McMaster University at 1 site in Canada.
Trial summary
Frailty is an important clinical state that contributes to falls, hospitalization, institutionalization and death. When an individual simultaneously has many health problems, a frailty "tipping point" may be triggered by even a minor stressful event such as adding a new drug or urinary tract infection. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Frailty
- What is being tested?
- Group Exercise, Nutrition and Medication review and Protein Supplement
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 324 participants
- Where
- 1 siteCanada
- Study dates
- 2 Sep 2022to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Community-dwelling ≥65 years of age
- Able to independently ambulate 25m with or without walking aid
- At high risk for mobility disability/functional limitations
- Received medical clearance
- Can arrange transportation to the YMCA up to 2x/week
- Proof of being fully vaccinated against COVID-19 and proof of identification
Who cannot join
- Unable to speak or understand English
- Currently attending a group exercise program
- Currently in a drug optimization study/program
- Currently taking protein supplements daily
- Significant cognitive impairment where they may have difficulty following two-step commands in group exercise
- Receiving palliative/end of life care
- Unstable angina or heart failure
- Unable to attend for more than 20% of trial duration
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
McMaster University - St. Peter's Hospital
Hamilton, Ontario, L8M1W9
Sherri Smith, 905 521 2100 ext. 77715, smithsher@hhsc.ca
Alexandra Papaioannou, MD, MSc
About this study
Official title: Frailty Rehabilitation: A Community-based Intervention to Promote Healthy Aging
Frailty is an important clinical state that contributes to falls, hospitalization, institutionalization and death. When an individual simultaneously has many health problems, a frailty "tipping point" may be triggered by even a minor stressful event such as adding a new drug or urinary tract infection. Our research suggests that approximately 23% of Canadians over age 65 are frail, and by age 85 this estimate increases to over 40%. As we learn more about frailty and its consequences, there is an urgent need to develop community-based interventions that will prevent or delay frailty in older adults. Our proposed study will examine if frailty rehabilitation program is an effective community-based intervention to promote healthy aging. The primary objective of our study is to determine if 4-month frailty rehabilitation improves physical function compared with control and exercise alone in community-dwelling older adults living with frailty and sarcopenia. Secondary objectives of our study are to determine if 4-months of frailty rehabilitation can improve functional abilities and reduce healthcare utilization during a 6-month follow-up period compared with control and exercise alone. Results will translate the first Canadian model of frailty and sarcopenia rehabilitation and management.
Read the detailed description
In this multi-arm randomized controlled trial (RCT), 324 community-dwelling older adults (aged 65+) with frailty and at high risk for mobility disability will be randomized into one of three arms (control, exercise only, multi-modal rehabilitation) stratified by sex, age and location preference. Rolling recruitment will occur with ten cohorts total (2-3 cohorts per site, n=33 participants per cohort), enrolled across the partner Young Men's Christian Association (YMCA) sites.
Building upon the RCT, we aim to understand which components of a functional rehabilitation program are essential to change the trajectory of sarcopenia in older adults and explore the feasibility of a functional rehabilitation program with older adults. All participants will be screened for sarcopenia at baseline. Of the 324 participants, a subset of participants with sarcopenia will undergo additional assessments.
A validated frailty questionnaire can be administered over the phone and will provide an estimate of frailty status.
Stratified block randomization (1:1 randomization ratio) with the allocation sequence generated by a computer will be used to randomly allocate eligible participants to their group assignment. Participants will be stratified based on their sex, age (<80 or >=80 years), and location preference. To protect against selection bias, the randomization sequence will be adequately concealed so that investigators/participants are not aware of the upcoming assignment. The proposed duration of treatment is 4-months.
Primary and secondary outcomes will be assessed at 0 and 4-months.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ControlOther
Participants randomized to the control arm will not receive any of the Frailty Management Interventions.
Group ExerciseBehavioural
A recent meta-analysis suggests 180 min/week of exercise (with a high challenge to balance) is most effective for fall prevention. Combined strength and endurance training performed at a moderate weekly frequency (i.e., two times per week) may promote marked gains on muscle hypertrophy, strength and power gains in frail older adults. Balance training is a key component of successful exercise programs for vulnerable older adults.
Nutrition and Medication reviewCombination product
Nutrition review: Conduct nutritional screening flow and review any questions, provide some additional counseling/coaching. Protein supplements will be provided to all participants unless contraindicated.
Medication review: Review/update current medication list and forward the list and medical history to the consultant study pharmacist.
Protein SupplementDietary supplement
Protein supplementation will be provided.
Vitamin DDietary supplement
1000 IU of oral vitamin D
| Study group | Role | What they receive |
|---|---|---|
| Arm1.Control | Experimental | Participants randomized to the control arm will not receive any of the Frailty Rehabilitation Interventions. Participants in the control arm will receive Vitamin D. Receives: Other: Control; Dietary Supplement: Vitamin D |
| Arm2.Group Exercise | Experimental | Participants will attend the exercise program, twice-weekly, for 4-months with supplemental home exercise. Receives: Behavioral: Group Exercise; Dietary Supplement: Vitamin D |
| Arm3.Multi-modal Intervention | Experimental | Group Exercise/Supplemental Home Exercise: This will be delivered identically to Arm 2.
Nutrition, protein supplementation, and a medication review will also be implemented. Receives: Behavioral: Group Exercise; Combination Product: Nutrition and Medication review; Dietary Supplement: Protein Supplement; Dietary Supplement: Vitamin D |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Physical Performance
Physical function will be assessed with the Short Performance Physical Battery [total score]. Higher scores indicate better physical performance [range 0-12].
Measured: Baseline and 4-months
Change in Walking Speed
Walking speed will be assessed with the 400-m Walk Test [walking speed, m/s]. Faster walking speeds indicate better performance.
Measured: Baseline and 4-months
Secondary outcomes (20)
Change in Frailty
Frailty will be assessed with the Fit-Frailty App [total score]. Higher scores indicate greater frailty [range 0-1].
Measured: Baseline and 4-months
Change in Fear of Falling
Iconographical Falls Efficacy Scale [total score]. Higher scores indicate greater fear of falling [range 16-28]
Measured: Baseline and 4-months
Change in Balance Confidence
Dichotomous questions (y/n)
Measured: Baseline and 4-months
Change in Falls
Number of falls will be assessed by self-report.
Measured: Baseline and 4-months
Change in Fitness
Fitness will be assessed with Fitness Trackers [average step count per day]. A greater number of steps indicates higher fitness level.
Measured: Baseline and 4-months
Change in Strength
Strength will be assessed with a handgrip dynamometer [kg].
Measured: Baseline and 4-months
Change in Functional Mobility
Strength will be assessed with the Timed Up and Go (TUG) Test [total time]. A higher score indicates a greater falls risk (greater or equal to 12 sec) and lower functional mobility.
Measured: Baseline and 4-months
Change in Cognition
Cognition will be assessed with the Montreal Cognitive Assessment [total score]. Higher scores indicate better cognition [range 0-30].
Measured: Baseline and 4-months
Change in Cognition
Cognition will be assessed with the Mini-Mental State Examination [total score]. Higher scores indicate better cognition [range 0-30].
Measured: Baseline and 4-months
Change in Health-related Quality of Life
Health-related quality of life will be assessed using a EuroQol instrument. Higher scores indicate better health-related quality of life [range 0-100].
Measured: Baseline and 4-months
Change in Life Space Mobility
Life space mobility will be assessed with the Life Space Assessment [total score]. Higher scores indicate a larger life space [range 0-120].
Measured: Baseline and 4-months
Change in Basic Activities of Daily Living
Activities of daily living will be assessed with the Katz activities of daily living questionnaire [total score]. Lower scores indicate greater impairment [range 0-6].
Measured: Baseline and 4-months
Change in Instrumental Activities of Daily Living
Activities of daily living will be assessed with Lawton instrumental activities of daily living questionnaire [total scores]. Lower scores indicate greater impairment [range 0-8].
Measured: Baseline and 4-months
Change in Depression / Mood
Depression and mood will be assessed with the Geriatric Depression Scale Short-Form [total score]. Higher scores indicate more depressive symptoms [range 0-15].
Measured: Baseline and 4-months
Change in Nutrition
Nutrition will be assessed with the Mini Nutritional Assessment [total score]. Lower scores indicate malnutrition [range 0-14].
Measured: Baseline and 4-months
Change in Sarcopenia
Sarcopenia will be assessed with the strength, assistance walking, rise from a chair, climb stairs, and falls (SARC-F) questionnaire [total score]. High scores (greater than or equal to 4) is predictive of sarcopenia [range 0-10].
Measured: Baseline and 4-months
Change in Muscle Mass
Muscle mass will be assessed with dual-energy x-ray absorptiometry (DXA) and magnetic resonance imaging (MRI). A subset of participants will be assessed.
Measured: Baseline and 4-months
Change in Emergency Room Visits
Number of emergency room visits will be recorded. Higher number of emergency room visits indicates higher healthcare utilization.
Measured: Baseline, 4-months and additional 6-month follow-up
Change in Hospitalizations
Number of hospitalizations will be recorded. Higher number of hospitalizations indicates higher healthcare utilization.
Measured: Baseline, 4-months and additional 6-month follow-up
Change in Institutionalization
Institutionalization to long-term care will be recorded. Higher number individuals entering long-term care indicates higher healthcare utilization.
Measured: Baseline, 4-months and additional 6-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2019
- Study start2 Sep 2022
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (54)Papers the sponsor has linked to this study.
- Other trials for FrailtyStudies of the same condition, open and under way.
- More trials run by McMaster UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 324 participants (estimated)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alexandra Papaioannou, MD, MSc, Principal investigator, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03824106
- Sponsor's protocol ID
- 5500
- Status last verified
- Nov 2024
- First submitted
- 22 Jan 2019
- Last updated
- 6 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 11253156Rockwood K, Mitnitski A. Frailty defined by deficit accumulation and geriatric medicine defined by frailty. Clin Geriatr Med. 2011 Feb;27(1):17-26. doi: 10.1016/j.cger.2010.08.008.
PubMed 21093719Kennedy CC, Ioannidis G, Rockwood K, Thabane L, Adachi JD, Kirkland S, Pickard LE, Papaioannou A. A Frailty Index predicts 10-year fracture risk in adults age 25 years and older: results from the Canadian Multicentre Osteoporosis Study (CaMos). Osteoporos Int. 2014 Dec;25(12):2825-32. doi: 10.1007/s00198-014-2828-9. Epub 2014 Aug 8.
PubMed 25103215Rockwood K, Song X, Mitnitski A. Changes in relative fitness and frailty across the adult lifespan: evidence from the Canadian National Population Health Survey. CMAJ. 2011 May 17;183(8):E487-94. doi: 10.1503/cmaj.101271. Epub 2011 Apr 26.
PubMed 21540166Roberts KC, Rao DP, Bennett TL, Loukine L, Jayaraman GC. Prevalence and patterns of chronic disease multimorbidity and associated determinants in Canada. Health Promot Chronic Dis Prev Can. 2015 Aug;35(6):87-94. doi: 10.24095/hpcdp.35.6.01.
PubMed 26302227Rockwood K, Howlett SE, MacKnight C, Beattie BL, Bergman H, Hebert R, Hogan DB, Wolfson C, McDowell I. Prevalence, attributes, and outcomes of fitness and frailty in community-dwelling older adults: report from the Canadian study of health and aging. J Gerontol A Biol Sci Med Sci. 2004 Dec;59(12):1310-7. doi: 10.1093/gerona/59.12.1310.
PubMed 15699531Cameron ID, Fairhall N, Langron C, Lockwood K, Monaghan N, Aggar C, Sherrington C, Lord SR, Kurrle SE. A multifactorial interdisciplinary intervention reduces frailty in older people: randomized trial. BMC Med. 2013 Mar 11;11:65. doi: 10.1186/1741-7015-11-65.
PubMed 23497404Morley JE, Vellas B, van Kan GA, Anker SD, Bauer JM, Bernabei R, Cesari M, Chumlea WC, Doehner W, Evans J, Fried LP, Guralnik JM, Katz PR, Malmstrom TK, McCarter RJ, Gutierrez Robledo LM, Rockwood K, von Haehling S, Vandewoude MF, Walston J. Frailty consensus: a call to action. J Am Med Dir Assoc. 2013 Jun;14(6):392-7. doi: 10.1016/j.jamda.2013.03.022.
PubMed 23764209Anderson L, Oldridge N, Thompson DR, Zwisler AD, Rees K, Martin N, Taylor RS. Exercise-Based Cardiac Rehabilitation for Coronary Heart Disease: Cochrane Systematic Review and Meta-Analysis. J Am Coll Cardiol. 2016 Jan 5;67(1):1-12. doi: 10.1016/j.jacc.2015.10.044.
PubMed 26764059Dalal HM, Doherty P, Taylor RS. Cardiac rehabilitation. BMJ. 2015 Sep 29;351:h5000. doi: 10.1136/bmj.h5000. No abstract available.
PubMed 26419744Cheifetz O, Park Dorsay J, Hladysh G, Macdermid J, Serediuk F, Woodhouse LJ. CanWell: meeting the psychosocial and exercise needs of cancer survivors by translating evidence into practice. Psychooncology. 2014 Feb;23(2):204-15. doi: 10.1002/pon.3389. Epub 2013 Sep 6.
PubMed 24009181Cheifetz O, Dorsay JP, MacDermid JC. Exercise facilitators and barriers following participation in a community-based exercise and education program for cancer survivors. J Exerc Rehabil. 2015 Feb 28;11(1):20-9. doi: 10.12965/jer.150183. eCollection 2015 Feb.
PubMed 25830140Theou O, Stathokostas L, Roland KP, Jakobi JM, Patterson C, Vandervoort AA, Jones GR. The effectiveness of exercise interventions for the management of frailty: a systematic review. J Aging Res. 2011 Apr 4;2011:569194. doi: 10.4061/2011/569194.
PubMed 21584244Sherrington C, Michaleff ZA, Fairhall N, Paul SS, Tiedemann A, Whitney J, Cumming RG, Herbert RD, Close JCT, Lord SR. Exercise to prevent falls in older adults: an updated systematic review and meta-analysis. Br J Sports Med. 2017 Dec;51(24):1750-1758. doi: 10.1136/bjsports-2016-096547. Epub 2016 Oct 4.
PubMed 27707740Fairhall N, Aggar C, Kurrle SE, Sherrington C, Lord S, Lockwood K, Monaghan N, Cameron ID. Frailty Intervention Trial (FIT). BMC Geriatr. 2008 Oct 13;8:27. doi: 10.1186/1471-2318-8-27.
PubMed 18851754
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Frailty Rehabilitation: A Community-based Intervention to Promote Healthy Aging
- ClinicalTrials.gov ID
- NCT03824106
- Acronym / sponsor ID
- 5500
- Conditions
- Frailty
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 324 participants (estimated)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Study start
- 2 Sep 2022 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 31 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Frailty is an important clinical state that contributes to falls, hospitalization, institutionalization and death. When an individual simultaneously has many health problems, a frailty "tipping point" may be triggered by even a minor stressful event such as adding a new drug or urinary tract infection. Our research suggests that approximately 23% of Canadians over age 65 are frail, and by age 85 this estimate increases to over 40%. As we learn more about frailty and its consequences, there is an urgent need to develop community-based interventions that will prevent or delay frailty in older adults. Our proposed study will examine if frailty rehabilitation program is an effective community-based intervention to promote healthy aging. The primary objective of our study is to determine if 4-month frailty rehabilitation improves physical function compared with control and exercise alone in community-dwelling older adults living with frailty and sarcopenia. Secondary objectives of our study are to determine if 4-months of frailty rehabilitation can improve functional abilities and reduce healthcare utilization during a 6-month follow-up period compared with control and exercise alone. Results will translate the first Canadian model of frailty and sarcopenia rehabilitation and management.
Detailed description
In this multi-arm randomized controlled trial (RCT), 324 community-dwelling older adults (aged 65+) with frailty and at high risk for mobility disability will be randomized into one of three arms (control, exercise only, multi-modal rehabilitation) stratified by sex, age and location preference. Rolling recruitment will occur with ten cohorts total (2-3 cohorts per site, n=33 participants per cohort), enrolled across the partner Young Men's Christian Association (YMCA) sites.
Building upon the RCT, we aim to understand which components of a functional rehabilitation program are essential to change the trajectory of sarcopenia in older adults and explore the feasibility of a functional rehabilitation program with older adults. All participants will be screened for sarcopenia at baseline. Of the 324 participants, a subset of participants with sarcopenia will undergo additional assessments.
A validated frailty questionnaire can be administered over the phone and will provide an estimate of frailty status.
Stratified block randomization (1:1 randomization ratio) with the allocation sequence generated by a computer will be used to randomly allocate eligible participants to their group assignment. Participants will be stratified based on their sex, age (<80 or >=80 years), and location preference. To protect against selection bias, the randomization sequence will be adequately concealed so that investigators/participants are not aware of the upcoming assignment. The proposed duration of treatment is 4-months.
Primary and secondary outcomes will be assessed at 0 and 4-months.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm1.Control | Experimental | Other: Control, Dietary Supplement: Vitamin DParticipants randomized to the control arm will not receive any of the Frailty Rehabilitation Interventions. Participants in the control arm will receive Vitamin D. |
| Arm2.Group Exercise | Experimental | Behavioral: Group Exercise, Dietary Supplement: Vitamin DParticipants will attend the exercise program, twice-weekly, for 4-months with supplemental home exercise. |
| Arm3.Multi-modal Intervention | Experimental | Behavioral: Group Exercise, Combination Product: Nutrition and Medication review, Dietary Supplement: Protein Supplement, Dietary Supplement: Vitamin DGroup Exercise/Supplemental Home Exercise: This will be delivered identically to Arm 2. Nutrition, protein supplementation, and a medication review will also be implemented. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- Community-dwelling ≥65 years of age
- Able to independently ambulate 25m with or without walking aid
- At high risk for mobility disability/functional limitations
- Received medical clearance
- Can arrange transportation to the YMCA up to 2x/week
Key exclusion criteria (8 listed)
- Unable to speak or understand English
- Currently attending a group exercise program
- Currently in a drug optimization study/program
- Currently taking protein supplements daily
- Significant cognitive impairment where they may have difficulty following two-step commands in group exercise
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ControlParticipants randomized to the control arm will not receive any of the Frailty Management Interventions. | Other | Arm1.Control |
| Group ExerciseA recent meta-analysis suggests 180 min/week of exercise (with a high challenge to balance) is most effective for fall prevention. Combined strength and endurance training performed at a moderate weekly frequency (i.e., two times per week) may promote marked gains on muscle hypertrophy, strength and power gains in frail older adults. Balance training is a key component of successful exercise programs for vulnerable older adults. | Behavioural | Arm2.Group Exercise, Arm3.Multi-modal Intervention |
| Nutrition and Medication reviewNutrition review: Conduct nutritional screening flow and review any questions, provide some additional counseling/coaching. Protein supplements will be provided to all participants unless contraindicated. Medication review: Review/update current medication list and forward the list and medical history to the consultant study pharmacist. | Combination product | Arm3.Multi-modal Intervention |
| Protein SupplementProtein supplementation will be provided. | Dietary supplement | Arm3.Multi-modal Intervention |
| Vitamin D1000 IU of oral vitamin D | Dietary supplement | Arm1.Control, Arm2.Group Exercise, Arm3.Multi-modal Intervention |
Primary outcome
Change in Physical Performance
Time frame: Baseline and 4-months
Physical function will be assessed with the Short Performance Physical Battery [total score]. Higher scores indicate better physical performance [range 0-12].
Change in Walking Speed
Time frame: Baseline and 4-months
Walking speed will be assessed with the 400-m Walk Test [walking speed, m/s]. Faster walking speeds indicate better performance.
20 secondary outcomes
Change in Frailty
Time frame: Baseline and 4-months
Change in Fear of Falling
Time frame: Baseline and 4-months
Change in Balance Confidence
Time frame: Baseline and 4-months
Change in Falls
Time frame: Baseline and 4-months
Change in Fitness
Time frame: Baseline and 4-months
Change in Strength
Time frame: Baseline and 4-months
Change in Functional Mobility
Time frame: Baseline and 4-months
Change in Cognition
Time frame: Baseline and 4-months
Change in Cognition
Time frame: Baseline and 4-months
Change in Health-related Quality of Life
Time frame: Baseline and 4-months
Change in Life Space Mobility
Time frame: Baseline and 4-months
Change in Basic Activities of Daily Living
Time frame: Baseline and 4-months
Change in Instrumental Activities of Daily Living
Time frame: Baseline and 4-months
Change in Depression / Mood
Time frame: Baseline and 4-months
Change in Nutrition
Time frame: Baseline and 4-months
Change in Sarcopenia
Time frame: Baseline and 4-months
Change in Muscle Mass
Time frame: Baseline and 4-months
Change in Emergency Room Visits
Time frame: Baseline, 4-months and additional 6-month follow-up
Change in Hospitalizations
Time frame: Baseline, 4-months and additional 6-month follow-up
Change in Institutionalization
Time frame: Baseline, 4-months and additional 6-month follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2025.
- Background: PubMed 11253156Fried 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.
- Background: PubMed 21093719Rockwood K, Mitnitski A. Frailty defined by deficit accumulation and geriatric medicine defined by frailty. Clin Geriatr Med. 2011 Feb;27(1):17-26. doi: 10.1016/j.cger.2010.08.008.
- Background: PubMed 25103215Kennedy CC, Ioannidis G, Rockwood K, Thabane L, Adachi JD, Kirkland S, Pickard LE, Papaioannou A. A Frailty Index predicts 10-year fracture risk in adults age 25 years and older: results from the Canadian Multicentre Osteoporosis Study (CaMos). Osteoporos Int. 2014 Dec;25(12):2825-32. doi: 10.1007/s00198-014-2828-9. Epub 2014 Aug 8.
- Background: PubMed 21540166Rockwood K, Song X, Mitnitski A. Changes in relative fitness and frailty across the adult lifespan: evidence from the Canadian National Population Health Survey. CMAJ. 2011 May 17;183(8):E487-94. doi: 10.1503/cmaj.101271. Epub 2011 Apr 26.
- Background: PubMed 26302227Roberts KC, Rao DP, Bennett TL, Loukine L, Jayaraman GC. Prevalence and patterns of chronic disease multimorbidity and associated determinants in Canada. Health Promot Chronic Dis Prev Can. 2015 Aug;35(6):87-94. doi: 10.24095/hpcdp.35.6.01.
- Background: PubMed 15699531Rockwood K, Howlett SE, MacKnight C, Beattie BL, Bergman H, Hebert R, Hogan DB, Wolfson C, McDowell I. Prevalence, attributes, and outcomes of fitness and frailty in community-dwelling older adults: report from the Canadian study of health and aging. J Gerontol A Biol Sci Med Sci. 2004 Dec;59(12):1310-7. doi: 10.1093/gerona/59.12.1310.
- Background: PubMed 23497404Cameron ID, Fairhall N, Langron C, Lockwood K, Monaghan N, Aggar C, Sherrington C, Lord SR, Kurrle SE. A multifactorial interdisciplinary intervention reduces frailty in older people: randomized trial. BMC Med. 2013 Mar 11;11:65. doi: 10.1186/1741-7015-11-65.
- Background: PubMed 23764209Morley JE, Vellas B, van Kan GA, Anker SD, Bauer JM, Bernabei R, Cesari M, Chumlea WC, Doehner W, Evans J, Fried LP, Guralnik JM, Katz PR, Malmstrom TK, McCarter RJ, Gutierrez Robledo LM, Rockwood K, von Haehling S, Vandewoude MF, Walston J. Frailty consensus: a call to action. J Am Med Dir Assoc. 2013 Jun;14(6):392-7. doi: 10.1016/j.jamda.2013.03.022.
- Background: PubMed 26764059Anderson L, Oldridge N, Thompson DR, Zwisler AD, Rees K, Martin N, Taylor RS. Exercise-Based Cardiac Rehabilitation for Coronary Heart Disease: Cochrane Systematic Review and Meta-Analysis. J Am Coll Cardiol. 2016 Jan 5;67(1):1-12. doi: 10.1016/j.jacc.2015.10.044.
- Background: PubMed 26419744Dalal HM, Doherty P, Taylor RS. Cardiac rehabilitation. BMJ. 2015 Sep 29;351:h5000. doi: 10.1136/bmj.h5000. No abstract available.
- Background: PubMed 24009181Cheifetz O, Park Dorsay J, Hladysh G, Macdermid J, Serediuk F, Woodhouse LJ. CanWell: meeting the psychosocial and exercise needs of cancer survivors by translating evidence into practice. Psychooncology. 2014 Feb;23(2):204-15. doi: 10.1002/pon.3389. Epub 2013 Sep 6.
- Background: PubMed 25830140Cheifetz O, Dorsay JP, MacDermid JC. Exercise facilitators and barriers following participation in a community-based exercise and education program for cancer survivors. J Exerc Rehabil. 2015 Feb 28;11(1):20-9. doi: 10.12965/jer.150183. eCollection 2015 Feb.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Alexandra Papaioannou, MD, MSc principal investigator
McMaster University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group Exercise, Nutrition and Medication review and Protein Supplement in people with Frailty, run by McMaster University at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sherri Smith (905 521 2100 ext. 77715, smithsher@hhsc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Physical Performance (time frame: Baseline and 4-months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03824106, which also lists 54 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2025; AzTrials last refreshed its copy on 3 Nov 2026.