Pilates Method on Functional Capacity and Blood Pressure of Elderly Women With Type 2 Diabetes

NCT04952948 | Completed DMC

• 1 other identifier: 4
• Study Type: interventional
• Target: 22
• Locations: 0 countries
• Sites: N/A

Brief Summary

Type 2 diabetes mellitus (T2D) is a chronic inflammatory disease that is associated with loss of functional capacity and increased blood pressure. Coupled with this, there is an increased risk of falls and fractures in patients with T2D. On the other hand, conventional training programs for resistance, aerobic or combined exercises are strongly recommended for people with T2D, as they promote a reduction in the glycemic rate and blood pressure, and an improvement in functional capacity. However, little is known about unconventional training programs such as PILATES (dynamic and isometric muscle actions) on functional capacity and cardiovascular adaptations in T2D.

Conditions

Type-2 Diabetes; Physical Disability; Blood Pressure

Keywords

Resistance exercise; Functionality; Interruption; Diabetes; Cardiovascular

Outcome Measures

Primary Outcomes (8)

• Change in functional capacity in type-2 diabetes

  Measurements of functional capacity (time in seconds of execution of the functional tests) in the PILATES and CONTROL groups to be analyzed in the pre-intervention and post-intervention moments.

  Pre-intervention (week zero) versus 4 weeks of intervention in PILATES Group and CONTROL group

• Change in functional capacity in type-2 diabetes

  Measurements of functional capacity (time in seconds of execution of the functional tests) in the PILATES and CONTROL groups to be analyzed in the pre-intervention and post-intervention moments.

  Pre-intervention (week zero) versus 8 weeks of intervention in PILATES Group and CONTROL group

• Change in functional capacity in type-2 diabetes

  Measurements of functional capacity (time in seconds of execution of the functional tests) in the PILATES and CONTROL groups to be analyzed in the pre-intervention and post-intervention moments.

  Pre-intervention (week zero) versus 12 weeks post-intervention in PILATES Group and CONTROL group

• Change in functional capacity in type-2 diabetes

  Measurements of functional capacity (time in seconds of execution of the functional tests) in the PILATES and CONTROL groups to be analyzed in the pre-intervention and detraining moments.

  Pre-intervention (week zero) versus 4 weeks of detraining post-intervention in PILATES Group and CONTROL group

• Change in functional capacity in type-2 diabetes

  Measurements of functional capacity (time in seconds of execution of the functional tests) in the PILATES and CONTROL groups to be analyzed in the post-intervention and detraining moments.

  Pos-intervention (12 weeks) versus 4 weeks of detraining (4W_DT) in PILATES Group and CONTROL group

• Change in blood pressure in type-2 diabetes

  Measurements of systolic blood pressure and diastolic blood pressure (mmHg) in the PILATES and CONTROL groups to be analyzed in the pre-intervention and post-intervention moments.

  Pre-intervention (week zero) versus 4 weeks of intervention in PILATES Group and CONTROL group

• Change in lood pressure in type-2 diabetes

  Measurements of systolic blood pressure and diastolic blood pressure (mmHg) in the PILATES and CONTROL groups to be analyzed in the pre-intervention and post-intervention moments.

  Pre-intervention (week zero) versus 8 weeks of intervention in PILATES Group and CONTROL group

• Change in blood pressure in type-2 diabetes

  Measurements of systolic blood pressure and diastolic blood pressure (mmHg) in the PILATES and CONTROL groups to be analyzed in the pre-intervention and post-intervention moments.

  Pre-intervention (week zero) versus 12 weeks post-intervention in PILATES Group and CONTROL group

Study Arms (2)

PILATES Method Training Group

EXPERIMENTAL

The PILATES program at moderate intensity lasted 12 weeks, at a frequency of 3 times a week, and with duration of 60 minutes for each exercise session.

Other: PILATES Training

CONTROL Group

SHAM COMPARATOR

While the PILATES Group participated in the intervention with physical exercises, the CONTROL group only participated in the functional capacity and blood pressure assessments. However, at the end of the intervention in the PILATES Group, the CONTROL Group was invited to participate in a similar training program.

Other: PILATES Training

Interventions

PILATES Training OTHER

During the PILATES sessions, the practitioner received orientations to to perform slow movements, aware, and combined with the respiratory cycle. The exercises program was performed on a soft ground covered with tatamis. During the program, a set of swiss balls of 45, 55, and 65 cm in size and elastic bands of very moderate resistance were used. Each exercise session was divided into 3 stages, namely (a) global initial static and dynamic stretching (10 minutes); (b) general conditioning (45 minutes) and; (c) relaxation (5 minutes). The amount of series and repetitions per set in exercises, in addition to the intensity required in each session in PILATES is presented in Table 2 of Melo et al. (2020) - Vide reference.

CONTROL Group; PILATES Method Training Group

Eligibility Criteria

• Age: 60 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Present a diagnosis of type-2 diabetes;
• Do not have severe or decompensated heart disease;
• Do not have coronary artery disease;
• Do not have peripheral neuropathy and ulcers in the extremities;
• Do not have severe skin lesions;
• Do not have proliferative retinopathy;
• Do not have insulin therapy;
• Do not have any health condition that would hinder participation in the exercise sessions.

You may not qualify if:

• Present some unexpected abnormality in health conditions during the research;
• Do not participate in more than 80% of the training sessions in the PILATES group.

Sponsors & Collaborators

• Universidade Federal do vale do São Francisco: lead

Related Publications (1)

• Melo KCB, Araujo FS, Cordeiro Junior CCM, de Andrade KTP, Moreira SR. Pilates Method Training: Functional and Blood Glucose Responses of Older Women With Type 2 Diabetes. J Strength Cond Res. 2020 Apr;34(4):1001-1007. doi: 10.1519/JSC.0000000000002704.

  PMID: 29985228 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Exercise Movement Techniques

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Physical Therapy Modalities; Therapeutics

Study Officials

• Ilka Yolane TP Andrade, Ms

  Federal University of Vale do São Francisco - UNIVASF

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor (PhD)

Study Record Dates

• First Submitted: June 11, 2021
• First Posted: July 7, 2021
• Study Start: August 23, 2016
• Primary Completion: November 28, 2016
• Study Completion: December 19, 2016
• Last Updated: July 7, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share