Clinical trial NCT05948735: An Intervention Integrating Physical Therapy Exercise and Dance Movement Therapy for Preventing Falls in Older Adults
Official title: Construction and Assessment of an Intervention Model for Preventing Falls in Older Adults That Integrates Physiotherapy Exercise and Dance Movement Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Older Adults
Keywords: Older adults
Fall
Fall prevention intervention
Physical therapy
Dance movement therapy
Otago Exercise Program
Lead sponsor: University of Haifa
Sponsor class: OTHER
First posted: 2023-07-17
Enrollment: 61
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change in Fall Risk Self-Assessment from baseline at 6 weeks
timeFrame: Pre- and post-intervention: within 5 days before the intervention (baseline), and within 5 days after the intervention (after 6 weeks).
measure: Change in Functional Status Questionnaire - Basic Activities of Daily Living (ADL) from baseline at 6 weeks
timeFrame: Pre- and post-intervention: within 5 days before the intervention (baseline), and within 5 days after the intervention (after 6 weeks).
measure: Change in Timed Up and Go test from baseline at 6 weeks
timeFrame: Pre- and post-intervention: within 5 days before the intervention (baseline), and within 5 days after the intervention (after 6 weeks).
measure: Change in Five Times Sit to Stand (5STS) test from baseline at 6 weeks
timeFrame: Pre- and post-intervention: within 5 days before the intervention (baseline), and within 5 days after the intervention (after 6 weeks).
measure: Change in Fear of Falling single item question from baseline at 6 months
timeFrame: Pre- and post-intervention: within 5 days before the intervention (baseline), and within 5 days after the intervention (after 6 weeks). Also, one month, two months, and six months after the intervention.
measure: Change in Short Falls Efficacy Scale-International from baseline at 6 months
timeFrame: Pre- and post-intervention: within 5 days before the intervention (baseline), and within 5 days after the intervention (after 6 weeks). Also, one month, two months, and six months after the intervention.
measure: Change in The Patient Health Questionnaire from baseline at 6 months
timeFrame: Pre- and post-intervention: within 5 days before the intervention (baseline), and within 5 days after the intervention (after 6 weeks). Also, one month, two months, and six months after the intervention.
measure: Change in 12-item Short Form Health Survey (SF-12) from baseline at 6 weeks
timeFrame: Pre- and post-intervention: within 5 days before the intervention (baseline), and within 5 days after the intervention (after 6 weeks).
measure: Change in Exercise Adherence Rating Scale (EARS) from 7 weeks after the intervention at 6 months
timeFrame: Post-intervention: once a week after the intervention. Also, one month, two months, and six months after the intervention.
Secondary outcomes:
measure: Therapeutic Bond
timeFrame: Mid-test and post-intervention: During Cycle 1 (each cycle is 42 days), on the 14th day, 28th day, and at the end of Cycle 1 on the 42nd day.
measure: Subjective Vitality Scale (SVS)
timeFrame: Mid-test and post-intervention: During Cycle 1 (each cycle is 42 days), on the 14th day, 28th day, and at the end of Cycle 1 on the 42nd day.
measure: Patient's Expectations
timeFrame: Pre-intervention, mid-test, and post-intervention:Before Cycle 1 (each cycle is 42 days), during Cycle 1 on the 14th day, 28th day, and at the end of Cycle 1 on the 42nd day.
measure: Assessment of the quality of the intervention
timeFrame: Mid-test and post-intervention: During Cycle 1 (each cycle is 42 days), on the 14th day, 28th day, and at the end of Cycle 1 on the 42nd day.
Other outcomes:
Locations:
city: Kiryat Tivon; Yokneam; Haifa
country: Israel
facility: "Shalhevet" and "Savion" day centers; "Milav" social clubs
Study officials:
affiliation: Faculty of Social Welfare & Health Sciences, University of Haifa
name: Michal Pitluk Barash
role: PRINCIPAL_INVESTIGATOR
References: