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

25 września 2026 zaktualizowane przez: 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.

Przegląd badań

Status

Jeszcze nie rekrutacja

Warunki

Interwencja / Leczenie

Szczegółowy opis

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.

Typ studiów

Interwencyjne

Zapisy (Szacowany)

63

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

Kopia zapasowa kontaktu do badania

Lokalizacje studiów

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

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

50 lat i starsze (Dorosły, Starszy dorosły)

Akceptuje zdrowych ochotników

Nie

Płeć kwalifikująca się do nauki

Kobieta

Opis

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

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Zapobieganie
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Pojedynczy

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: Resistance exercise

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

Supervised progressive resistance exercise
Brak interwencji: wait-list control

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

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Change in the time (in seconds) taken to complete the timed up and go test test
Ramy czasowe: 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)

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
change in 30-second chair stand test
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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)

Inne miary wyników

Miara wyniku
Opis środka
Ramy czasowe
Bone density
Ramy czasowe: Baseline and 6 months (post-training)

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

Measured by dual x-ray absorptiometry
Baseline and 6 months (post-training)
Short Form-36 Health Survey
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: Week 3, 15, and 26

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

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

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

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

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

continuous glucose monitoring
once per week between weeks 1 and 26
level 2 hypoglycemia
Ramy czasowe: 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)
Ramy czasowe: once per week between weeks 1 and 26

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

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

continuous glucose monitoring
once per week between weeks 1 and 26

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Institut de Recherches Cliniques de Montreal

Współpracownicy

University of Alberta
McMaster University

Śledczy

  • Główny śledczy: Jane E Yardley, PhD, Institut de Recherches Cliniques de Montreal

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Szacowany)

1 grudnia 2026

Zakończenie podstawowe (Szacowany)

1 września 2030

Ukończenie studiów (Szacowany)

1 grudnia 2030

Daty rejestracji na studia

Pierwszy przesłany

21 września 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

25 września 2026

Pierwszy wysłany (Rzeczywisty)

1 października 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

1 października 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

25 września 2026

Ostatnia weryfikacja

1 września 2026

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • 2027-1393

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIE

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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