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

25. september 2026 opdateret af: Jane Yardley, Institut de Recherches Cliniques de Montreal

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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

63

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

Studiesteder

  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 2E1
        • Alberta Diabetes Institute
        • Kontakt:
    • Ontario
      • Hamilton, Ontario, Canada
        • McMaster University
        • Kontakt:
    • Quebec
      • Montreal, Quebec, Canada, H2W 1R7
        • Institut de recherches cliniques de Montreal
        • Kontakt:
        • Kontakt:
          • Kia Salimi, PhD

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

50 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Kvinde

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Resistance exercise

Supervised progressive resistance exercise training three times weekly
Adfærdsmæssigt: Resistance exercise

Supervised progressive resistance exercise
Ingen indgriben: wait-list control

Usual care. Participants will be offered the training program at the end of the 6-month control period.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in the time (in seconds) taken to complete the timed up and go test test
Tidsramme: Baseline and 6 months (post-training)

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)

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
change in 30-second chair stand test
Tidsramme: Baseline and 6 months (post-training)

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
Tidsramme: Baseline and 6 months (post-training)

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
Tidsramme: Baseline and 6 months (post-training)

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
Tidsramme: Baseline and 6 months (post-training)

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)

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Bone density
Tidsramme: Baseline and 6 months (post-training)

Measured using dual x-ray absorptiometry
Baseline and 6 months (post-training)
Lean body mass
Tidsramme: Baseline and 6 months (post-training)

Measured by dual x-ray absorptiometry
Baseline and 6 months (post-training)
Short Form-36 Health Survey
Tidsramme: Baseline and 6 months (post-training)

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)
Tidsramme: Baseline and 6 months (post-training)

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)
Tidsramme: Baseline and 6 months (post-training)

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)
Tidsramme: Baseline and 6 months (post-training)

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
Tidsramme: Baseline and 6 months (post-training)

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)
Tidsramme: Baseline and 6 months (post-training)

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
Tidsramme: Baseline and 6 months (post-training)

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
Tidsramme: Week 3, 15, and 26

3-day food diary
Week 3, 15, and 26
Background physical activity
Tidsramme: weeks 3, 15, and 26

7-day accelerometry measures
weeks 3, 15, and 26
insulin dose
Tidsramme: weeks 3, 15, 26

self-reported
weeks 3, 15, 26
changes in medication (other than insulin)
Tidsramme: weeks 3, 15, 26

self-reported changes in medication
weeks 3, 15, 26
glucose time in range
Tidsramme: once per week between weeks 1 and 26

measured by continuous glucose monitoring
once per week between weeks 1 and 26
glucose time below range
Tidsramme: once per week between weeks 1 and 26

continuous glucose monitoring
once per week between weeks 1 and 26
level 1 hypoglycemia
Tidsramme: once per week between weeks 1 and 26

continuous glucose monitoring
once per week between weeks 1 and 26
level 2 hypoglycemia
Tidsramme: once per week between weeks 1 and 26

measured by continuous glucose monitoring
once per week between weeks 1 and 26
Severe hypoglycemia (level 3)
Tidsramme: once per week between weeks 1 and 26

continuous glucose monitoring
once per week between weeks 1 and 26
time above range
Tidsramme: once per week between weeks 1 and 26

continous glucose monitoring
once per week between weeks 1 and 26
Glycemic variability
Tidsramme: once per week between weeks 1 and 26

continuous glucose monitoring
once per week between weeks 1 and 26

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Institut de Recherches Cliniques de Montreal

Samarbejdspartnere

University of Alberta
McMaster University

Efterforskere

  • Ledende efterforsker: Jane E Yardley, PhD, Institut de Recherches Cliniques de Montreal

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. december 2026

Primær færdiggørelse (Anslået)

1. september 2030

Studieafslutning (Anslået)

1. december 2030

Datoer for studieregistrering

Først indsendt

21. september 2026

Først indsendt, der opfyldte QC-kriterier

25. september 2026

Først opslået (Faktiske)

1. oktober 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

1. oktober 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

25. september 2026

Sidst verificeret

1. september 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 2027-1393

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