Functional Mobility and Resistance Exercise for Postmenopausal Females With Type 1 Diabetes

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age50+
SponsorInstitut de Recherches Cliniques de Montreal

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Resistance exercise

    Behavioral

    Supervised progressive resistance exercise

Treatment groups

63 Participants
are divided into 2 treatment groups
Group A: Resistance exerciseExperimental treatment 1 intervention
Group B: wait-list controlNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
Baseline and 6 months (post-training)

Secondary outcomes

1

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

Time frame
Baseline and 6 months (post-training)
2

Change in 6-minute walk test

The number of meters walked around a set course in 6 minutes will be measured

Time frame
Baseline and 6 months (post-training)
3

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

Time frame
Baseline and 6 months (post-training)
4

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.

Time frame
Baseline and 6 months (post-training)

Other outcomes

1

Bone density

Measured using dual x-ray absorptiometry

Time frame
Baseline and 6 months (post-training)
2

Lean body mass

Measured by dual x-ray absorptiometry

Time frame
Baseline and 6 months (post-training)
3

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.

Time frame
Baseline and 6 months (post-training)
4

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.

Time frame
Baseline and 6 months (post-training)

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Institut de Recherches Cliniques de Montreal

Lead sponsor

McMaster University

Collaborator

University of Alberta

Collaborator

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