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

NCT05948735 | Completed

• 1 other identifier: UHaifa ME-G ESE MPB
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

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. 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. 2.What are the factors of change in an intervention that integrates physical exercises and emotional content?
3. 3.Is there a correlation between the outcome variables and the process variables in the study?

Conditions

Older Adults

Keywords

Older adults; Fall; Fall prevention intervention; Physical therapy; Dance movement therapy; Otago Exercise Program

Outcome Measures

Primary Outcomes (9)

• Change in Fall Risk Self-Assessment from baseline at 6 weeks

  Fall risk assessment will perform using the Fall Risk Self-Assessment Tool (FRQ), which is a self-report questionnaire that includes 12 items rated on a dichotomous scale of "yes" or "no". The overall score of the questionnaire is the sum of the items to which the answer is "yes", and the score range is between 0 and 14. A score of 4 or higher indicates a level of risk of falling that requires a visit to a healthcare provider.

  Pre- and post-intervention: within 5 days before the intervention (baseline), and within 5 days after the intervention (after 6 weeks).

• Change in Functional Status Questionnaire - Basic Activities of Daily Living (ADL) from baseline at 6 weeks

  An assessment of Functioning in ADL will perform using the Functional Status Questionnaire-Basic ADL, which is a self-report questionnaire, specifically the functional assessment of performing activities in daily life (Activities of Daily Living \[ADL\]). The questionnaire includes a "Basis ADL" subscale, which consists of three items rated on a 5-point ordinal scale ranging from 0 (mostly did not perform due to other reasons) to 4 (mostly without difficulties), reflecting the degree of difficulty the individual experiences in performing daily activities such as eating, dressing, and bathing. The general score of the questionnaire scale was calculated by ((sum of items/number of items) - number of items) \* (100/number of items), yielding a score range of 0 to 100, with a higher score indicating higher functional capacity. A score range between 0 and 87 is considered a warning zone and indicates a possibility of danger.

  Pre- and post-intervention: within 5 days before the intervention (baseline), and within 5 days after the intervention (after 6 weeks).

• Change in Timed Up and Go test from baseline at 6 weeks

  Objective balance assessment will perform using the Timed Up and Go (TUG) test. The time taken by participants while rising from a chair (46 cm height), for walking 3 m, turning, walking back, and sitting down, was measured. The TUG is conducted twice, and the average of the two test scores determine the overall score. A score higher than 13.5 seconds indicates a risk of falling among community-dwelling older adults

  Pre- and post-intervention: within 5 days before the intervention (baseline), and within 5 days after the intervention (after 6 weeks).

• Change in Five Times Sit to Stand (5STS) test from baseline at 6 weeks

  Objective balance assessment will perform using the Five Times Sit to Stand (5STS) test. The time taken by participants while getting up from a seated position in a chair and standing up and sitting down five times, was measured. Norm scores for ages 70 to 79 and 80 to 89 are 12.6 seconds and 14.8 seconds, respectively.

  Pre- and post-intervention: within 5 days before the intervention (baseline), and within 5 days after the intervention (after 6 weeks).

• Change in Fear of Falling single item question from baseline at 6 months

  Fear of Falling assessment will perform using the FOF single item question (FOF SIQ) which is a single self-report question: "Are you afraid of falling?". The question is rated on a Likert-type scale ranging from 1 (no, not afraid) to 4 (yes, indeed afraid).

  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.

• Change in Short Falls Efficacy Scale-International from baseline at 6 months

  Falls Efficacy assessment will perform using the Short Falls Efficacy Scale-International (Short FES-I), which is a self-report questionnaire that includes seven items rated on a Likert-type scale ranging from 1 (not at all concerned) to 4 (extremely concerned). The overall score of the questionnaire is the sum of its items, and the score range is be-tween 7 and 28. A lower score indicates better self-efficacy related to falls.

  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.

• Change in The Patient Health Questionnaire from baseline at 6 months

  Depression Assessment Questionnaire assessment will perform using the Patient Health Questionnaire (PHQ-9), which is a self-report questionnaire used to assess the presence and severity of depression. It consists of 9 items that list major depressive symptoms, based on the Diagnostic and Statistical Manual of Mental Disorders, and are rated on a 4-point scale ranging from 0 (not at all) to 3 (almost every day). The overall score of the questionnaire is calculated by summing the scores of all items and ranges from 0 to 27, with a higher score indicating a higher level of distress and depression. The researchers propose the following levels of depression: score 0 to 5 indicates absence of depression; score 6 to 9 indicates subsymptomatic/low depression; score 10 to 14 indicates moderate depression; score 15 to 19 indicates moderate-severe depression; and score 20 to 27 indicates severe depression.

  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.

• Change in 12-item Short Form Health Survey (SF-12) from baseline at 6 weeks

  Self-perceived health status assessment will perform using the 12-item Short Form Health Survey (SF-12), which is a self-report questionnaire that includes 12 items that are summarized as two scores: the Physical Component Summary (PCS-12), which refers to the physical aspect of health status, and the Mental Component Summary (MCS-12), which refers to the mental aspect of health status. Four items are rated on a dichotomous yes/no scale, while the remaining items are rated on a Likert-type scale with response options ranging from 3 to 6. The average score in each component is 50, and the standard deviation is 10. The overall scores range from 0 to 100. A higher score indicates a better perception of health status and quality of life.

  Pre- and post-intervention: within 5 days before the intervention (baseline), and within 5 days after the intervention (after 6 weeks).

• Change in Exercise Adherence Rating Scale (EARS) from 7 weeks after the intervention at 6 months

  Weekly telephone follow-up will be conducted for a month after the end of the intervention to assess persistence in the home practice program, including the number of days of practice per week and the number of exercises performed. In addition, home exercise adherence assessment will performed using the Exercise Adherence Rating Scale (EARS), which assesses an individual's adherence to performing exercises which were instructed by healthcare professional to perform at home. This self-report questionnaire includes six items rated on a Likert-type scale ranging from 0 (Completely agree) to 4 (Completely disagree). In one item, the phrase "my healthcare professional" was replaced with "the group instructor" to align with the study. The overall score of the questionnaire is the sum of its items, and the score range is between 0 and 24. A higher score indicating a higher level of adherence to performing exercises at home.

  Post-intervention: once a week after the intervention. Also, one month, two months, and six months after the intervention.

Secondary Outcomes (4)

• Therapeutic Bond

  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.

• Subjective Vitality Scale (SVS)

  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.

• Patient's Expectations

  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.

• Assessment of the quality of the intervention

  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.

Study Arms (2)

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

EXPERIMENTAL

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

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

Physical Therapy Exercise (PTE)

ACTIVE COMPARATOR

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.

Other: Physical Therapy Exercise (PTE) only for Preventing Falls

Interventions

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

Physical Therapy Exercise (PTE) only for Preventing Falls 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.

Physical Therapy Exercise (PTE)

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• Community-dwelling adults aged 65 years or older.
• Ability to independently walk for at least 10 meters with or without an assistive device.
• Ability to walk for 2 minutes without an assistive device.

You may not qualify if:

• Heart disease or respiratory disease.
• A history of stroke, Parkinson's, or any other neurological disorder affecting walking.
• Blindness or deafness that would prevent safe walking and hearing instructions.
• A vestibular disorder such as vertigo.
• Acute joint or musculoskeletal pain in the lower limbs that would limit continuous walking for 2 minutes.
• Significant sensory problems in the lower limbs.

Sponsors & Collaborators

• University of Haifa: lead

Study Sites (1)

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

Kiryat Tivon; Yokneam; Haifa, Israel

Location

MeSH Terms

Interventions

Single Person

Intervention Hierarchy (Ancestors)

Marital Status; Family Characteristics; Demography; Population Characteristics; Socioeconomic Factors

Study Officials

• Michal Pitluk Barash

  Faculty of Social Welfare & Health Sciences, University of Haifa

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants will be blinded to the allocation to groups, and investigator will not be involved in the intervention process.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ph.D. - Physical Therapy Department, Faculty of Social Welfare & Health Sciences, University of Haifa, Haifa, Israel

Study Record Dates

• First Submitted: June 19, 2023
• First Posted: July 17, 2023
• Study Start: July 6, 2023
• Primary Completion: January 6, 2025
• Study Completion: February 1, 2025
• Last Updated: March 19, 2025

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)