Functional Mobility and Resistance Exercise for Postmenopausal Females With Type 1 Diabetes (FLEX-T1D)

A Randomized Controlled Trial of Functional MobiLity and Resistance EXercise for Postmenopausal Females With Type 1 Diabetes: the FLEX-T1D Trial

Improvements in diabetes care and technology have led to people with type 1 diabetes living longer. There are now more seniors than ever living with this complex health condition. With aging, type 1 diabetes affects both bone (more brittle), and muscle (loss of size and strength). This loss happens faster and to a greater extent in females than in males, and greatly increases the risk of frailty and falls. It may also occur more quickly in individuals who have higher blood glucose (sugar) levels.

Frailty is an important factor to address. In older females, even mild frailty decreases the ability to perform day-to-day tasks, and increases the risk of fractures, falls, hospitalization, and even death. Performing regular exercise helps to maintain the strength and quality of both muscles and bones with aging. The best type of exercise to help maintain the ability to perform activities of daily living (known as functional mobility) for this population is currently unknown. Resistance exercise (weightlifting) helps to prevent decreases in mobility in seniors without diabetes. However, in the context of type 1 diabetes, high blood sugar levels could negatively impact these potential strength benefits and low blood glucose could lead to falls. As such, any exercise program that causes swings in glucose levels may hinder rather than help.

The goal of this study is to evaluate the effect of weightlifting over a 6-month timeframe on functional mobility in postmenopausal females with type 1 diabetes, compared to a group that does not train. the investigators will also assess its effects on blood sugar variability and the risk of hypoglycemia. Like different medications, not all exercise is equal. Creating more knowledge about the benefits of specific types of exercise in this population will allow us to be more precise in our exercise recommendations for living longer and more independently with type 1 diabetes.

Study Overview

• Status: Not yet recruiting
• Conditions: Menopause; Type 1 Diabetes (T1D)
• Intervention / Treatment: Behavioral: Resistance exercise

Detailed Description

Background: Type 1 diabetes, an autoimmune condition resulting in the near-absence of insulin secretion, requires lifelong exogenous insulin to manage blood glucose levels. Due to fear of hypoglycemia, which can be fatal, many people with type 1 diabetes maintain blood glucose levels slightly higher than the physiological range. This hyperglycemia is associated with many diabetes-related complications, including nephropathy, retinopathy, neuropathy and cardiovascular disease. It is also associated with an accelerated decrease in bone quality and muscle strength/quality with aging, creating a higher risk of age-related musculoskeletal fragility. The effects are more prominent in females than they are in males, particularly after menopause. As a result, postmenopausal females with type 1 diabetes have an especially high risk of frailty.

Frailty among older adults with type 1 diabetes is an important problem to address. With improvements in diabetes care/technology, people with type 1 diabetes are living longer, leading to a higher prevalence of type 1 diabetes among seniors. In older females without diabetes, even mild frailty decreases the ability to perform day-to-day tasks, and increases the risk of fractures, falls, hospitalization and even death. These risks may be accentuated for postmenopausal females living with type 1 diabetes. Regular exercise helps to maintain the strength and quality of muscles and bones with aging. The best type of exercise to help maintain functional mobility in postmenopausal females with type 1 diabetes while not sacrificing tight glycemic management is currently unknown. Resistance exercise (weight lifting) helps prevent decreases in mobility in seniors without diabetes. In people with type 1 diabetes it is often associated with smaller blood glucose declines than aerobic exercise during activity, but has also been reported to increase blood glucose levels in some situations.

It may also increase hypoglycemia occurrence in the hours after exercise. Hyperglycemia could negatively affect potential strength benefits. Frequent hypoglycemia increases the risk of falls and injury. Unfortunately, most of the available data were collected on young, fit males, limiting our ability to create evidence-based exercise guidelines for healthful and independent aging for postemenopausal females with type 1 diabetes. As there are known sex-related differences in physiological exercise responses and gender-related differences in activity preferences, studying females and males separately is warranted.

Goal: The goal of the study is to create knowledge around resistance exercise effects on functional mobility in postmenopausal females with type 1 diabetes. The investigators will also assess their impact on 24-hour glycemia (continuous glucose monitoring), bone mineral density (DXA) and self-reported quality of life. Finally, the investigators will compare these outcomes to a group who did not exercise during the same time frame.

Methods/Approaches: To achieve this goal, the investigators will conduct a 6-month randomized controlled trial across three sites to assess the impact of supervised resistance exercise on functional mobility (timed up and go test) compared to no exercise in postmenopausal females with type 1 diabetes. The investigators will recruit postmenopausal females with type 1 diabetes who are not currently meeting physical activity guidelines. All participants will undergo a 4-week run-in period for exercise familiarization and diabetes care optimization, followed by 22 weeks of the assigned treatment. Measures will be taken before run-in and at the end of the intervention by personnel blinded to group assignment.

Expected Outcomes: This project will fill an important void in the information being used to produce evidence-based guildeines for people with type 1 diabetes by providing more precise advice for postmenopausal females with type 1 diabetes.

• Study Type: Interventional
• Enrollment (Estimated): 63
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jane E Yardley, PhD; Phone Number: 1-514-987-5568; Email: jane.yardley@umontreal.ca
• Study Contact Backup: Name: Corinne Suppere, MSc; Email: csuppere@ircm.qc.ca

Study Locations

• Canada
  • Alberta
    • Edmonton, Alberta, Canada, T6G 2E1
      • Alberta Diabetes Institute
      • Contact: Normand G Boulé, PhD; Phone Number: 1-780-492-4695; Email: nboule@ualberta.ca
  • Ontario
    • Hamilton, Ontario, Canada
      • McMaster University
      • Contact: Irena Rebalka, PhD; Phone Number: 22273 1-905-525-9140; Email: rebalka@mcmaster.ca
  • Quebec
    • Montreal, Quebec, Canada, H2W 1R7
      • Institut de recherches cliniques de Montreal
      • Contact: Corinne Suppere, MSc; Phone Number: 514-987-5597; Email: csuppere@ircm.qc.ca
      • Contact: Kia Salimi, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• 1) female
• 2) clinical diagnosis of T1D requiring continuous insulin therapy [(either by multiple daily injections or continuous subcutaneous insulin infusion (insulin pumps)] for > 1 yr
• 3) aged ≥60 yrs, or ≥50 yrs with signs or symptoms of clinical frailty (level 4 on the Clinical Frailty Scale)
• 4) physically inactive (<30 mins of aerobic activity <3x/week; no resistance exercise)
• 5) postmenopausal (no menstrual periods in the previous 12 months, or who have had a hysterectomy and bilateral salpingo-oophorectomy with ≥1 yr having elapsed since surgery)

Exclusion Criteria:

• 1) unable to communicate in English/French
• 2) unwilling/unable to sign informed consent
• 3) having performed RT in the past 6 months
• 4) recent (last 3 months) or multiple episodes (>2 in last 12 months) of severe hypoglycemia and/or diabetic ketoacidosis
• 5) those with PA restrictions due to:
• a) intermittent claudication
• b) severe peripheral neuropathy
• c) active proliferative retinopathy
• d) unstable cardiac or pulmonary disease
• e) disabling stroke
• f) significant renal disease (estimated GFR<25 mL/min/1.73 m2 or urine albumin/creatinine ratio >150 mg/mmol)
• g) uncontrolled hypertension (BP>150 mmHg systolic or >95 mmHg diastolic while seated)
• h) musculoskeletal injury, foot wound or amputation that would affect the ability to exercise

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Resistance exercise; Supervised progressive resistance exercise training three times weekly	Behavioral: Resistance exercise; Supervised progressive resistance exercise
No Intervention: wait-list control; Usual care. Participants will be offered the training program at the end of the 6-month control period.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in the time (in seconds) taken to complete the timed up and go test test	The test begins with the participant sitting correctly in a chair with arms fixed (so as not to move when the participant stands), with her back resting on the back of the chair. When the timer says "Go" the participant will stand, walk to a line 3 metres away from the chair, turn around, walk back and sit down. The timing starts with "Go" and ends when the participant is seated.	Baseline and 6 months (post-training)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
change in 30-second chair stand test	The number of full stands that can be completed in 30 sec with hands folded across the chest	Baseline and 6 months (post-training)
Change in 6-minute walk test	The number of meters walked around a set course in 6 minutes will be measured	Baseline and 6 months (post-training)
Change in isometric grip strength	Participants will stand with their arm at their side; elbow bent at 90 degrees. Applying the force in a smooth motion, they will squeeze a dynamometer as hard as possible for 5 secs. This test will be performed three times for each hand, with the average of the three measurements being recorded	Baseline and 6 months (post-training)
Eight repetition maximum (8RM) strength test	The participants will perform repetitions of the exercise as weight is gradually increased until the weight at which they can only perform 8 repetitions with good form. Exercises will include leg press and chest press.	Baseline and 6 months (post-training)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bone density	Measured using dual x-ray absorptiometry	Baseline and 6 months (post-training)
Lean body mass	Measured by dual x-ray absorptiometry	Baseline and 6 months (post-training)
Short Form-36 Health Survey	The questionnaire contains 36 items that assess 8 health domains: 1) Physical functioning, 2) role limitations due to physical health, 3) bodily pain, 4) general health perceptions, 5) vitality, 6) social functioning, 7) role limitations due to emotional problems, and 8) mental health. Each domain is scored from 0 to 100 with higher scores indicating better health status.	Baseline and 6 months (post-training)
Diabetes-Specific Quality of Life Questionnaire (DSQOL)	This is a patient-reported questionnaire designed to assess how living with type 1 diabetes affects quality of life. The English-language validated survey contains six factors: social aspects, fear of hypoglycemia, dietary restrictions, physical complaints, anxiety about the future and daily hassles. It contains 64 items with multiple subscales with respondents rating statements using a 1 to 6-point Likert-type response scale. Subscale scores are calculated separately. Higher scores generally indicate better diabetes-specific quality of life and greater treatment satisfaction.	Baseline and 6 months (post-training)
Barriers to Physical Activity in Type 1 Diabetes (BAPAD-1)	This questionnaire assesses perceived barriers to engaging in regular physical activity among adults with type 1 diabetes. It contains 12 items, each rated on a 1 to 7-point Likert scale. Higher scores indicate that the item is more likely to be a barrier to physical activity for the individual.	Baseline and 6 months (post-training)
Diabetes Distress Scale (DDS-17)	The survey contains 17 items, each rated on a scale of 1 (not a problem) to 6 (very serious problem). The four domains include emotional burden, regimen distress, physical-related distress, and interpersonal distress. The overall score is calculated by dividing the sum of the items scored by the total number of items, providing an overall score between 1 (no distress) and 6 (high distress).	Baseline and 6 months (post-training)
Katz Index of Independence in Activities of Daily Living	The questionnaire evaluates functional status by assessing independence in six basic activities: bathing, dressing, toileting, transferring (moving between bed and chair), continence and feeding. Each activity is scored as 1 (independent) or 0 (requires assistance or complete help). The scores are summed to produce a total score from 0 to 6, with 0-1 being severely dependent, and 6 being fully independent.	Baseline and 6 months (post-training)
Clarke Hypoglycemia Awareness Questionnaire (Clarke Score)	This is an 8-item questionnaire used to assess impaired awareness of hypoglycemia in people with type 1 diabetes. It contains 8 questions addressing: recognition of hypoglycemia symptoms, loss of warning symptoms over time, frequency of moderate hypoglycemic episodes, frequency of severe hypoglycemic episodes, frequency of symptomatic hypoglycemia, frequency of asymptomatic hypoglycemia, glucose level at which symptoms are perceived and confidence in recognizing low glucose levels by symptoms. Answers are classified as A (aware) or R (reduced awareness). A lower number of R scores indicates better awareness. A score of 4 or greater is considered clinically significant impaired awareness of hypoglycemia.	Baseline and 6 months (post-training)
Pittsburgh Sleep Quality Index	The PSQI measures an individual's perception of their sleep quality over the previous month. It contains 19 self-rated questions. It contains 7 component scores, each ranging from 0 (no difficulty) to 3 (severe difficulty). The component scores are summed to create a global score ranging from 0 to 21, with lower scores indicating better sleep quality.	Baseline and 6 months (post-training)
Diet	3-day food diary	Week 3, 15, and 26
Background physical activity	7-day accelerometry measures	weeks 3, 15, and 26
insulin dose	self-reported	weeks 3, 15, 26
changes in medication (other than insulin)	self-reported changes in medication	weeks 3, 15, 26
glucose time in range	measured by continuous glucose monitoring	once per week between weeks 1 and 26
glucose time below range	continuous glucose monitoring	once per week between weeks 1 and 26
level 1 hypoglycemia	continuous glucose monitoring	once per week between weeks 1 and 26
level 2 hypoglycemia	measured by continuous glucose monitoring	once per week between weeks 1 and 26
Severe hypoglycemia (level 3)	continuous glucose monitoring	once per week between weeks 1 and 26
time above range	continous glucose monitoring	once per week between weeks 1 and 26
Glycemic variability	continuous glucose monitoring	once per week between weeks 1 and 26

Collaborators and Investigators

• Sponsor: Institut de Recherches Cliniques de Montreal
• Collaborators: University of Alberta; McMaster University
• Investigators: Principal Investigator: Jane E Yardley, PhD, Institut de Recherches Cliniques de Montreal

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2026
• Primary Completion (Estimated): September 1, 2030
• Study Completion (Estimated): December 1, 2030

Study Registration Dates

• First Submitted: September 21, 2026
• First Submitted That Met QC Criteria: September 25, 2026
• First Posted (Actual): October 1, 2026

Study Record Updates

• Last Update Posted (Actual): October 1, 2026
• Last Update Submitted That Met QC Criteria: September 25, 2026
• Last Verified: September 1, 2026

More Information

Terms related to this study

• Keywords: randomized controlled trial; resistance exercise; supervised training
• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Autoimmune Diseases; Immune System Diseases; Glucose Metabolism Disorders; Diabetes Mellitus; Nutritional and Metabolic Diseases; Diabetes Mellitus, Type 1; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Therapeutics; Physical Therapy Modalities; Patient Care; Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Physical Conditioning, Human; Exercise; Resistance Training
• Other Study ID Numbers: 2027-1393

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No