An Intervention Integrating Physical Therapy Exercise and Dance Movement Therapy for Preventing Falls in Older Adults

NCT ID: NCT05948735

Last Updated: 2025-03-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 61 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-07-06
• Study Completion Date: 2025-02-01

Brief Summary

The goal of this study is to construct and assess a theoretical and interventional model for preventing falls in older adults that integrates physiotherapy exercise and dance movement therapy.

The main questions this study aims to answer are:

1. What is the effect on reducing fall risk in older adults of a group intervention focused solely on physical exercises, compared to a similar intervention that incorporates emotional content through dance movement therapy?

2. What are the factors of change in an intervention that integrates physical exercises and emotional content?

3. Is there a correlation between the outcome variables and the process variables in the study?

Researchers will compare: (1) an intervention group that integrates physical therapy exercises (PTE) and dance movement therapy (DMT), and (2) a PTE control group, to examine the effects on: (1) physical, (2) emotional, and (3) adherence to treatment.

Detailed Description

First, an invitation to participate in the study will be published through day centers and associations for older adults. Any participant who expresses interest in participating will receive a phone call from a researcher who is not involved in the intervention. During the call, they will receive a detailed explanation of the study. Additionally, an initial screening test will be conducted to determine the inclusion and exclusion criteria. Participants who meet the criteria will be asked to obtain permission from their family doctor to participate in group physical activity sessions aimed at preventing falls.

Second, each participant will be required to sign an informed consent form and complete a socio-demographic characteristics questionnaire during a meeting with the research coordinator held at the participants' day centers. Subsequently, a research assistant, who is not involved in the intervention, will conduct pre-intervention tests at the day centers. These tests will last approximately an hour and will involve administering questionnaires related to fall risk, daily functioning, fear of falling, falls-efficacy, perception of health status, depression, and the participants' expectations of the intervention. If needed, the research assistant will assist participants in reading and marking their answers to ensure consistency in how the questions are presented, taking into account each participant's level of attentiveness.

In addition, a research assistant with a bachelor's degree in physical therapy will perform two objective measurements to assess the participants' balance level using the Timed Up and Go (TUG) test and the Five Times Sit to Stand (5STS) test. Following the tests, the participants will be randomly assigned to groups using a random number table.

Each intervention group will consist of eight participants to allow the facilitator to address all participants and ensure their safety. The participants will attend 12 face-to-face group sessions, meeting twice a week for 6 weeks. The sessions will take place in suitable-sized rooms in the day centers visited by the participants. After each session, the group facilitator will complete a questionnaire to assess the adherence to the protocol (treatment fidelity), which will be reviewed by supervisors. Additionally, at the end of the second and fourth weeks, a research assistant will conduct a mid-test via telephone with the intervention groups participants, focusing on their experience of the treatment, satisfaction with the intervention, the therapist-patient relationship, and open-ended questions to evaluate the nature of the intervention.

At the end of the intervention, all groups will be instructed to independently perform the structured home practice exercises twice a week for the next six months, starting one week after the end of the intervention.

Within a week after the intervention concludes, each participant will undergo the same series of tests conducted prior to the intervention by the same research assistants. Furthermore, process indicators will be assessed. A telephone follow-up will be conducted once a week for a month by the research assistant to evaluate the participants' adherence to the home practice program. This follow-up will involve a structured questionnaire assessing the number of practice days per week and the number of exercises performed. At the end of the month, an open-ended question will be asked to evaluate the quality of the intervention for the intervention group participants. One month, two months, and six months after the intervention concludes, the research assistant will administer the questionnaires related to fear of falling, falls-efficacy, depression, and adherence to home physical activity via telephone to all participants.

Conditions

Older Adults

Study Design

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

Study Groups

Physical Therapy Exercise and Dance Movement Therapy (PTE+DMT)

The intervention include 12 face-to-face group sessions of 45 minutes each, twice a week for 6 weeks. The intervention integrates Otago Exercise Program (OEP)-based techniques and DMT techniques to address the emotional experience that arises during physical exercise. This include encouragement for spontaneous and creative movement on the part of the participants, and an invitation to verbally share the feelings, sensations, and thoughts that arose in the participants following the movement. At the end of the sessions, participants will be instructed to perform nine exercises independently at home, at a minimum of twice per week for six months

Group Type: EXPERIMENTAL

Physical Therapy Exercise and Dance Movement Therapy (PTE+DMT) for Preventing Falls

Intervention Type: OTHER

The intervention include 12 face-to-face group sessions of 45 minutes each, twice a week for 6 weeks. The intervention integrates OEP-based techniques and DMT techniques to address the emotional experience that arises during physical exercise. This include encouragement for spontaneous and creative movement on the part of the participants, and an invitation to verbally share the feelings, sensations, and thoughts that arose in the participants following the movement. At the end of the sessions, participants will be instructed to perform nine exercises independently at home, at a minimum of twice per week for six months.

Physical Therapy Exercise (PTE)

The intervention include 12 face-to-face group sessions of 45 minutes each, twice a week for 6 weeks. The intervention include OEP-based techniques only. At the end of the sessions, participants will be instructed to perform nine exercises independently at home, at a minimum of twice per week for six months.

Group Type: ACTIVE_COMPARATOR

Physical Therapy Exercise (PTE) only for Preventing Falls

Intervention Type: OTHER

The intervention include 12 face-to-face group sessions of 45 minutes each, twice a week for 6 weeks. The intervention include OEP-based techniques only. At the end of the sessions, participants will be instructed to perform nine exercises independently at home, at a minimum of twice per week for six months.

Interventions

Physical Therapy Exercise and Dance Movement Therapy (PTE+DMT) for Preventing Falls

The intervention include 12 face-to-face group sessions of 45 minutes each, twice a week for 6 weeks. The intervention integrates OEP-based techniques and DMT techniques to address the emotional experience that arises during physical exercise. This include encouragement for spontaneous and creative movement on the part of the participants, and an invitation to verbally share the feelings, sensations, and thoughts that arose in the participants following the movement. At the end of the sessions, participants will be instructed to perform nine exercises independently at home, at a minimum of twice per week for six months.

Intervention Type: OTHER

Physical Therapy Exercise (PTE) only for Preventing Falls

The intervention include 12 face-to-face group sessions of 45 minutes each, twice a week for 6 weeks. The intervention include OEP-based techniques only. At the end of the sessions, participants will be instructed to perform nine exercises independently at home, at a minimum of twice per week for six months.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Community-dwelling adults aged 65 years or older.

2. Ability to independently walk for at least 10 meters with or without an assistive device.

3. Ability to walk for 2 minutes without an assistive device.

Exclusion Criteria

1. Heart disease or respiratory disease.

2. A history of stroke, Parkinson's, or any other neurological disorder affecting walking.

3. Blindness or deafness that would prevent safe walking and hearing instructions.

4. A vestibular disorder such as vertigo.

5. Acute joint or musculoskeletal pain in the lower limbs that would limit continuous walking for 2 minutes.

6. Significant sensory problems in the lower limbs.

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Haifa

OTHER

Sponsor Role: lead

Responsible Party

Michal Elboim

Ph.D. - Physical Therapy Department, Faculty of Social Welfare & Health Sciences, University of Haifa, Haifa, Israel

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Michal Pitluk Barash

Role: PRINCIPAL_INVESTIGATOR

Faculty of Social Welfare & Health Sciences, University of Haifa

Locations

"Shalhevet" and "Savion" day centers; "Milav" social clubs

Kiryat Tivon; Yokneam; Haifa, , Israel

Countries

Israel

Other Identifiers

UHaifa ME-G ESE MPB

Identifier Type: -

Identifier Source: org_study_id