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

NCT ID: NCT07165119

Last Updated: 2025-09-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-01
• Study Completion Date: 2021-12-01

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.

Detailed Description

In line with the global trend, the elderly population is increasing in Turkey and the prevalence of diabetes in the elderly population continues to be high. According to the results of the Turkish Diabetes Epidemiology Study (TURDEP2), diabetic patients over the age of 65 constitute approximately 40% of all diabetics. Diabetes in an older person also increases the risk of developing frailty syndrome, which is associated with reduced muscle strength, reduced muscle quality and loss of muscle mass and accelerated aging. Muscle strength and function are reduced in diabetic patients with type 2 diabetes compared to healthy, non-glycemic individuals, with an increase in BMI and a decrease in muscle quality, when estrogen drops, especially in menopausal women. However, people with T2D may have an increased risk of falls and fractures, which may be partly explained by a decrease in muscle mass. Limited mobility can have a major impact on the individual's independence when basic daily activities like getting up from the chair, climbing stairs, and grocery shopping are disrupted for the elderly person. Decreased muscle strength can be an important factor in this loss of mobility.

In addition to physical changes, diabetes in older people also leads to emotional, mental and social difficulties and conflicts. Negative experiences such as anxiety, depression, tension and lack of social support in individuals with diabetes have bad consequences on diabetes, exacerbate the disease and increase the burden of the disease on the individual. According to the preliminary findings of the National Burden of Disease Research performed in Turkey, it has been reported that there has been a 60% increase in the burden of illness related to diabetes and that it ranks first among the burden-causing diseases. In line with all these results, a holistic approach to the phenomenon of diabetes will provide holistic interventions for the multiple effects of diabetes. However, interventions about diabetes management for the diabetic elderly are limited in the literature. Many studies have been conducted with diabetic elderly people. However, this study is the first study that includes an interdisciplinary group study for diabetic elders. The present study was organized to assess the effectiveness of these practices of an interdisciplinary care approach on the general health parameters of elderly individuals with Type 2 Diabetes.

Conditions

Type 2 Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: SINGLE

Study Groups

Interdisciplinary group

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

Group Type: EXPERIMENTAL

Interdisciplinary group

Intervention Type: 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.

Nurse Coaching group

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

Group Type: ACTIVE_COMPARATOR

Nurse Coaching group

Intervention Type: OTHER

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

Clinical Pilates group

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

Group Type: ACTIVE_COMPARATOR

Clinical Pilates Group

Intervention Type: 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

Control group

Control group: 12 week waiting list for 12 participants.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Interdisciplinary group

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.

Intervention Type: OTHER

Clinical Pilates Group

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

Intervention Type: OTHER

Nurse Coaching group

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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

• Minimum Eligible Age: 65 Years
• Maximum Eligible Age: 95 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Çankırı Karatekin University

OTHER

Sponsor Role: collaborator

Hacettepe University

OTHER

Sponsor Role: lead

Responsible Party

Kutay Kaslı

Dr

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Huri Seval Gönderen Çakmak, Phd

Role: STUDY_DIRECTOR

Çankırı Karatekin University

Locations

Çankırı Karatekin University Eldivan Vocational School of Health Services

Çankırı, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

Kutay Kaşlı

Identifier Type: OTHER

Identifier Source: secondary_id

435

Identifier Type: -

Identifier Source: org_study_id