The Effect of the Interdisciplinary Care Approach on General Health Parameters in Older Adults With Type 2 Diabetes

NCT07165119 | Completed

• 2 other identifiers: 435Kutay Kaşlı
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the study was evaluation of the effect of the clinical Pilates, nurse coaching and Peer group work Approach on General Health Parameters in older adults with Diabetes. This study was conducted as a single-blind, 4-arm, single-randomized and controlled study to estimate the effect of clinical Pilates, nurse coaching and peer group work approach on general health parameters in elderly individuals with diabetes mellitus. Interdisciplinary group treatment was carried out by a physiotherapist, social worker, diabetes nurse, and family physician. Clinical Pilates group treatment was carried out by a physiotherapist, and nurse coaching group treatment was carried out by a diabetes nurse. Measurements of the functional capacity of the elderly were evaluated with the Lafayette manual muscle tester and the Jamar hydraulic hand grip dynamometer. A total of 48 aged people with diabetes were randomized into 4 arms. The arms were followed up for 12 weeks.

Conditions

Type 2 Diabetes

Keywords

elderly diabetic; nurse coaching; Pilates; interdisciplinary care

Outcome Measures

Primary Outcomes (11)

• Geriatric Anxiety Inventory

  The scale's main feature is its ability to differentiate between anxious and non-anxious groups, as well as between those with and without generalised anxiety disorder. The Turkish version of the Geriatric Anxiety Inventory was used. Scores obtained from the scale range from 0 to 20. Higher scores indicate higher anxiety levels in older individuals.

  From enrollment to the end of treatment at 12 weeks.

• Glycosylated hemoglobin

  The glycosylated hemoglobin level is measured as a percentage according to the reference protocol of the International Federation of Clinical Chemistry. Blood samples from each patient were collected in the morning after fasting, with glycosylated hemoglobin level measurements taken one week before and again at the end of the 12-week period.

  From enrollment to the end of treatment at 12 weeks.

• Berg Balance Scale

  The Berg Balance Scale is a 14-item scale that quantitatively evaluates balance and fall risk. Performance is directly observed. Scores of 0 to 20 represent a lack of balance, 21 to 40 indicate acceptable balance and 41 to 56 show good balance. This scale can be used to evaluate both static and dynamic balance

  From enrollment to the end of treatment at 12 weeks.

• Yesavage Geriatric Depression Scale

  The scale developed by Yesavage et al., consists of 30 questions and is used as a basic screening criterion for major and minor depression. Data obtained using the Yesavage Geriatric Depression Scale were categorized as follows: 'no depression' for individuals with a score below 11; 'probable depression' for individuals with a score between 12 and 14; and 'depression' for individuals with a score of 14 or above

  From enrollment to the end of treatment at 12 weeks.

• Type 2 Diabetes Self-Management Scale

  The scale allows for individualized assessments of lifestyle, blood glucose management and healthcare utilisation in people with type 2 Diabetes. The scale consists of 19 items across three dimensions. The healthy lifestyle behaviours subscale contains 11 items; the blood glucose management subscale contains four items; and the utilizing health services subscale contains four items

  From enrollment to the end of treatment at 12 weeks

• Elderly Diabetes Burden Scale

  Araki et al. developed the scale for assessing diabetic-specific psychological aspects with 6 subscales (symptom burden, dietary restrictions, social burden, worry about diabetes, treatment dissatisfaction, and burden by tablets or insulin). The total score range for this scale is 18-88. Validity and reliability in Turkish were examined by Usta and Esen in 2012. An increase in scale scores indicates an increase in the burden in that area, and a decrease in scores indicates a low burden in that area. The Cronbach alpha coefficient for the scale was found to be 0.92

  From enrollment to the end of treatment at 12 weeks.

• 30 Seconds Sit to Stand Test

  In the study, the 30 second sit-stand test was used, which evaluates lower body strength and endurance in older adults. Protocol developed by Rikli and Jones to determine the physical fitness levels of older adults between the ages of 60-94. The patient is asked to sit and then stand unaided for 30 seconds, and performing less than 8 repetitions is a risk indicator

  From enrollment to the end of treatment at 12 weeks.

• Timed Up&Go Test

  The Timed Up\&Go Test includes independent measures of mobility and functional ability, including standing up from a chair, walking, turning, stopping, and sitting again. The person is asked to get up from the chair they are sitting in, walk 3 meters, come back and sit on the chair again, and the elapsed time is recorded

  From enrollment to the end of treatment at 12 weeks.

• Gait speed measurement

  Participants were asked to walk along a 4-metre track at their normal speed. This is an effective way of determining a person's physical function. Those who generally walk faster than 1 m/s tend to have a better functional status, a lower risk of health problems, and a higher survival rate

  From enrollment to the end of treatment at 12 weeks.

• Hand Grip Strength

  Muscle strength was evaluated through handgrip measurements using a handheld dynamometer (TKK 5001. Grip-A; Takei. Tokyo. Japan). Each participant completed three maximal grip trials with the left hand, followed by three with the right, with 1-min rest intervals between attempts. The test is a determinant of age-related decline in physical function

  From enrollment to the end of treatment at 12 weeks.

• Strength of Upper/Lower Limbs

  The handheld dynamometer (HHD), which measures isometric muscle strength, is a simple to use, easy to carry, inexpensive and light device. Quadriceps femoris, hamstring, tibialis anterior, iliopsoas, gluteus medius, biceps brachii, and shoulder abductor muscles evaluated with a handheld dynamometer

  From enrollment to the end of treatment at 12 weeks.

Other Outcomes (1)

• The Standardized Mini Mental State Examination

  to enrollment of participants in the enrollment session.

Study Arms (4)

Interdisciplinary group

EXPERIMENTAL

For 12 weeks, 3 times interdisciplinary treatment for 12 participants.

Other: Interdisciplinary group

Nurse Coaching group

ACTIVE COMPARATOR

nurse coaching for 12 weeks lasting 45 minutes once a week for 12 participants.

Other: Nurse Coaching group

Clinical Pilates group

ACTIVE COMPARATOR

Clinical Pilates For 12 weeks, 3 times exercise for 12 participants.

Other: Clinical Pilates Group

Control group

NO INTERVENTION

Control group: 12 week waiting list for 12 participants.

Interventions

Interdisciplinary group OTHER

For 12 weeks, the subjects in the interdisciplinary group participated in 45 minutes of clinical Pilates three times a week, as in the clinical Pilates group, and 45 minutes of nurse coaching once a week, as in the nurse coaching group.

Interdisciplinary group

Clinical Pilates Group OTHER

Clinical Pilates was applied by a certified physiotherapist for 12 consecutive weeks. with 45-minute sessions 3 times a week and was delivered to small groups of participants (3-5). The Pilates program has been developed in accordance with the extant literature to cultivate strength, balance, and coordination in a range of body positions, including the supine, seated, kneeling, and standing positions. Participants were instructed to perform each movement with control and precision, focusing on proper breathing patterns (exhaling during flexion, inhaling during extension) and engaging their core muscles throughout the exercise The load level and progression were determined using the Borg CR10 scale: Borg ≤ 2 = light load; Borg \> 2 - \< 5 = moderate load; Borg ≥ 5 - \< 7 = heavy load; Borg ≥ 7 = near-maximum load. During the sessions, the effort level was generally maintained at a moderate intensity (Borg 3-4). Each time the intensity of the exercise was changed, the new loa

Clinical Pilates group

Nurse Coaching group OTHER

Training and follow-up was carried out with nurse coaching for 12 weeks lasting 45 minutes once a week .

Nurse Coaching group

Eligibility Criteria

• Age: 65 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• individuals who were independently mobile,
• had been diagnosed with Type 2 Diabetes for a minimum of six months,
• had no serious complications or mental health issues,
• participated in regular medical check-ups,
• had no communication problems,
• agreed to participate in the study voluntarily
• aged 65 years or older.

You may not qualify if:

• older adults with a standardized mini-mental state examination (MMSE) score below 17
• older adults with serious complications that prevented them from participating in group activities

Sponsors & Collaborators

• Hacettepe University: lead
• Çankırı Karatekin University: collaborator

Study Sites (1)

Çankırı Karatekin University Eldivan Vocational School of Health Services

Çankırı, 18100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

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

Study Officials

• Huri Seval Gönderen Çakmak, Phd

  Çankırı Karatekin University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Blinded assessors conducted initial and post-treatment assessments of participants in the study. Training was carried out on different days.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Model Details: The study was carried out as a single-blind, 4-arm randomized controlled trial.

Study Record Dates

• First Submitted: August 27, 2025
• First Posted: September 10, 2025
• Study Start: May 1, 2021
• Primary Completion: September 1, 2021
• Study Completion: December 1, 2021
• Last Updated: September 10, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)