Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT05527574 |
| Other study ID # |
Pro00089513 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
November 30, 2019 |
| Est. completion date |
August 22, 2025 |
Study information
| Verified date |
September 2023 |
| Source |
University of Alberta |
| Contact |
Diana Mager, PhD MSc RD |
| Phone |
780-492-7687 |
| Email |
mager[@]ualberta.ca |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
One of the most common problems in people with diabetes (DM) and chronic kidney disease (CKD)
is the high frequency of other coinciding medical conditions such as osteoporosis and
frailty. Frailty in particular is very common in adults with DM and CKD and it can result in
significant muscle weakness which can result in increasing difficulties with performing
activities of daily life (ADL). This can lead to an increase risk for falls, bone fractures
and increasing hospitalization. The investigators have showed that adults with DM and CKD who
have frailty use hospital services more frequently, have reduced quality of life and
difficulties with performing their ADLs1. There is some evidence that early screening for
frailty and lifestyle interventions that focus on healthier eating and physical activity can
help prevent frailty from getting worse. The study purpose is to develop and test a
home-based lifestyle intervention program focused on optimizing diet and the ability to
perform your ADLs in adults with DM and CKD. The goal of this program is to ensure that
adults with DM can live healthier lives within the community.
Description:
Research Hypothesis: A home based video program focused on education related to lifestyle
modification (diet, physical activity) over 6 months will result in improved measures of
muscle strength/muscle functionality, health related quality of life and reduced measures of
frailty and health care utilization in adults with DM and CKD.
V. Expected Outcomes: Results from this study will address two important questions a)
identification of features of frailty/pre-frailty in adults with DM and CKD who should be
targeted for lifestyle intervention b) development of home based programming for individuals
with pre-frailty/frailty in the community dwelling adults with DM. This information is needed
to help our clinical teams screen for frailty/pre-frailty and to focus health care resources
on developing rehabilitation strategies to prevent and treat adults patients with DM and
Frailty. This is particularly relevant for those who are 'vulnerable to Frailty' (pre-frail),
but do not have the full condition. Prevention of the progression to full FRAILTY is critical
to ensure optimal mental health HRQOL, to reduce health care use and to improve diabetes
interventions in the community for those most vulnerable (Core Area 1). This will promote
healthy aging in the community setting in obese adults with DM by supporting independent
living, quality of life, mental health and delayed care utilization (Core Area 2) and will
ensure healthy lives and promote well-being of all adults with DM at all ages (Goal 3).
Study Design:
There are two phases of this study. 1) Development of Video programming and 2) Open-label
non-blinded study.
Phase 1 (see Table 1): Home Video content will be developed based on the principals of social
cognitive theory. Video content will include two components a) resistance exercise (based on
Canadian Diabetes Association video's that are adapted to meet the patient's functional
capacity and b) the concepts of nutrition literacy. This will be done so a comprehensive
approach to the lifestyle factors known to contribute to frailty (diet, exercise) can be
developed in the educational programming of the video content (mp4 files). The resistance
exercises will based upon Diabetes Canada resistance exercises which will have been adapted
to meet the functional abilities of the patients in this population (based on the
Investigator's earlier studies in DM and CKD) (Mager et al Can J Diabetes 2019) and
https://www.diabetes.ca/getmedia/0a646e26-9e1c-4769-975f-51876edf6ecd/resistance-band-exercis
es-2.pdf.aspx ). Video content filming will be supported in the field by trained RA/graduate
student and exercise specialists and then vetted for content and face validity by experts in
the field (PT, MD, RD, geriatrician and exercise specialist CI and collaborators). We will
also elicit patient feedback in vetting video content from participants from ongoing studies
in the area (Pro00049292) and/or by recruiting potentially interested patients in the
clinics. Participants who participate in this phase of the study will not be enrolled into
Phase 2 of the study.
Table 1: Home Based Video Content (Mager/Manns/Boule/Juby) Phases Goals Nutrition Exercise
Months:0-2
Training & Education Weight bearing and basic resistance exercise training
Optimizing Diet Quality (DQ) (glycemic control) Healthy Eating Carbohydrate counting Protein,
Fat Micronutrients Weight bearing and balance activities: Establish routine walking
activities. Goal setting/pace setting.
Resistance training: Elastic bands (1-2 sets/session) for 30 min x 3 times/wk Upper/lower
limbs Months:2-4 Strength, Power & Endurance
DQ & Diet Diversity Increasing exercise endurance, power and training for weight bearing and
resistance activities
Optimizing DQ (glycemic control, electrolyte status) Healthy Eating & Meal Preparation Sodium
Potassium Phosphorus Glycemic Index Glycemic Load Weight bearing and balance activities (10
min sessions; 3 times weekly)
Resistance Activities:
Elastic bands (2-3 sets/session) for 30 minutes x 3 times weekly including upper/lower limbs
Months 4-6 Maintenance
Nutrition Literacy Endurance, power activities for weight bearing, balance and resistance
exercise.
Nutrition literacy/DQ Healthy Eating & Nutrition Literacy Food labels Grocery shopping
Grocery Budgets Weight bearing/balance activities (10 minute session; 3-4 times weekly).
Resistance Activities: Elastic bands (3-4 sets/session) for 30 minutes x 3-4 times/week.
Upper/lower limbs
Phase 2 Research Plan and Study Design: This is an open-label, non-blinded RCT. Participants
will be recruited from the Diabetes Nephropathy Prevention Clinics (DNPC) and Renal
Insufficient Clinics (RIC) in the Northern Alberta Renal Program (NARP) and undergo frailty
screening by trained research personnel to determine frailty vs pre-frailty status using
validated methodologies prior to randomization. Following this, the Investigators will
randomize 120 participants (60/gp in blocks of frail vs non-frail) to one of two arms of the
study: home based video intervention (n=60) or standard therapy (n=60) (diet/physical
activity counseling) in a block design (frail (n=30/gp) vs pre-frail (n=30/gp)) at baseline
(Figure 1).
Screening for frailty will be performed prior to randomization using the validated Clinical
Frailty Scale; a tool widely used by clinicians to screen for frailty risk in many clinical
populations. This tool takes approximately 5 minutes to administer and can be readily
administered by trained research personnel in clinic. Study analysis will compare outcomes
based on frail vs pre-frail in each group allocation (Frail (n=30) vs Pre-Frail (n=30); for a
total of 60/group or 120 participants). The investigators will use a randomizer software
(randomizer.org) to randomize study participants.
Study Visits: Visits to the Diabetes and Physical Activity Laboratory (DPAL)/Clinical
Research Unit (CRU) at the University of Alberta will be made at baseline and 6 months for
education related to study video technology/content (Table 1) and to perform study
measurements related to frailty assessments, body composition, muscle strength,
weight-bearing activity, HRQOL, mental health, cognition and anthropometrics . The
Investigators will book DEXA scans at baseline and 6 months follow up with Medical Imaging
Consultants; run by certified radiologists. There are two sites: one located within walking
distance of the Clinical Research Unit, University of Alberta and one site located at Terra
Losa, 9566- 170 Street, Edmonton AB. Education will include instruction re: video content on
the electronic devices provided, review questionnaire content at baseline with weekly
telephone calls to both groups in the first month to address questions. Home visits will be
made q monthly by trained RA/graduate student to assess adherence to the prescribed therapies
and to address concepts related to diet, nutrition literacy, and ALDs (Figure 1 and Table 1).
Figure 1: Study Design with primary and secondary outcomes
Standard of Care: This focuses on diet education aimed at promoting glycemic control
(carbohydrate counting), electrolyte balance and increasing physical activity using Diabetes
Canada and AHS Nutrition Education materials. Education related to physical activity is aimed
at decreasing sedentary hours/increasing activity as per current Diabetes Canada Guidelines
and Health Canada guidelines19. Participants randomized to the standard of care group will
receive an accelerometer and will have monthly home visits by the RA to ensure equivalency of
care in terms of the number of interactions with health care providers. This is necessary to
reduce the risk for bias in study outcomes related to exposure to health care providers. This
education will be conducted by a registered dietitian (RD) who is part of the research team.
Participants will be provided with electronic devices as per Intervention group
(questionnaires as per the intervention will be provided which will have standard educational
materials uploaded on the devices.
Home Based Rehabilitation Intervention: Participants will be provided with a video (mp4
files) that will be uploaded to compatible portable electronic devices (such as tablets or
lap tops). Tablets or other electronic devices will not require internet connections as the
mp4 files will be uploaded on the devices prior to study start. Participants will listen and
participate in video instruction for 3 times weekly (30-40 min; resistance
exercise/balance/walking activities) and once/week for 15-20 minutes for nutrition based
content. All exercises on the mp4 files will be performed by trained exercise specialists.
Questionnaires will be linked directly to each of the mp4 files on the electronic devices
used for the instruction, ensuring that participants can directly answer validated
questionnaires related to nutrition literacy (Self-Perceived Nutrition Literacy Scale 20),
ADL independence (Barthel Index 21 and Lawton and Brody Scale 22 ) and food intake directly.
This will make it simple and easy for participants to fill out questionnaires directly on the
electronic devices where they viewed the home rehabilitation mp4 files. These will be filled
out in the last week prior to the final visit by the team and then reviewed at the time of
the visit. All data will be de-identified and answers from these scales will be downloaded
onto a password protected-encrypted portable drive by the RA at the time of the home visit
and/or via the internet (where available in the households).
Resistance training (RT) exercise; performed 3 times weekly for 30 minutes (Table 2): RT will
be performed during the 6 months; 3 times/week in non-consecutive days for approximately 30
minutes sessions according to established guidelines. An additional 5 minute segments at the
beginning/end of RT for warm-up/warm down will be provided. Programming and education will
have an emphasis on patient participation in the RT programming to promote increased
adherence. The RT will include the use of elastic bands. Elastic resistance provides similar
prime mover, antagonist, assistant movers and stabilizer muscle activation as other forms
resistance exercise in recreational users and have been validated in adults with frailty and
are relatively inexpensive and easy to use.23 24 The elastic bands will be provided to study
participants and instruction by an exercise specialist provided at the baseline visit.
RT routine: A circuit order of RT will be used for all major muscle groups; (Table 2). The
order of the exercises will be randomly presented on the different mp4 files uploaded on the
electronic devices to avoid an 'order effect' between individuals. Apps/icons on the
electronic devices will be sufficiently large to ensure visual acuity and will be labelled to
inform participant selection for weekly RT exercise.
