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NCT Number: NCT07741513

Balance Workshops Focusing on Learning to Stand Up From the Floor for Older Adults Living at Home: A Pilot Study Sol'Up

Falls among older adults are a major public health issue, accounting for approximately 2 million incidents annually in France, resulting in more than 10,000 deaths and 130,000 hospitalizations. Their cost is estimated at nearly 2 billion euros per year and is expected to rise as the population ages.

Falls result from multiple factors, including biological, behavioral, and environmental factors, with balance and gait disorders playing a central role. Their consequences include loss of independence, restricted activity, and fear of falling.

The ability to get back up from the ground after a fall is still largely overlooked. Yet up to two-thirds of older adults who have fallen are unable to get up on their own, exposing them to serious complications and an increased risk of further falls. This skill remains under-assessed and under-trained.

Physical activity-particularly programs combining balance, muscle strengthening, and functional training-can reduce the risk of falling by approximately 20 to 30 percent. Balance workshops are widely used for this purpose. However, these interventions primarily focus on fall prevention and rarely address fall management, particularly the ability to get up from the floor. Specific interventions targeting this skill are still underdeveloped, with mixed results.

The integration of structured training in getting up from the floor into balance workshops

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Key information

Conditions

Balance Control in Elderly Fall Prevention

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Association KPAURA RHONE

Valence, 26000, France

About this study

The primary objective of this study is to explore the feasibility and acceptability of integrating a soil survey training module into a balance workshop program for older adults living at home.

The secondary objectives of this study are to explore the potential effects of the program on certain functional and psychosocial dimensions among participants, by conducting an exploratory comparison between the intervention group and the control group.

The study will aim to assess:

  • the ability to get up from the floor;
  • functional mobility;
  • functional strength of the lower limbs;
  • postural balance;
  • confidence in balance during daily activities;
  • perceived self-efficacy for getting up from the floor;
  • level of physical activity;
  • the number of falls The feasibility of the intervention will be assessed based on the fidelity of its implementation: adherence to the content, the instructional progression, and the duration of the scheduled sessions. This aspect will be evaluated by the research team using a standardized monitoring form completed by the physical therapists.

The acceptability of the intervention will be assessed based on the following factors:

  • Participants' satisfaction with the program, as measured by a satisfaction questionnaire administered at the end of the intervention.
  • Physical therapists' satisfaction with the program, as measured by a satisfaction questionnaire administered at the end of the intervention.
  • Program adherence, assessed by the session attendance rate (number of sessions attended relative to the total number of sessions offered) as well as the dropout rate during the program.

The secondary outcome measures aim to explore the potential impact of the intervention by comparing the intervention group and the control group. Measurements will be taken at the beginning of the program (T0) and at the end (T1) regarding:

  • Ability to stand up from the floor, assessed using a standardized floor-to-standing test, which evaluates the level of assistance required (0: cannot stand up, 1: with assistance, 2: without assistance) and the time required to stand up.
  • Functional mobility, assessed using the Timed Up and Go (TUG) test:
  • Functional strength of the lower limbs, assessed using the Five-Time Sit-to-Stand Test (FTSST)
  • Postural balance, assessed using the Romberg test, the tandem stance test, and the single-leg stance test.
  • Confidence in balance during daily activities (Activities-specific Balance Confidence Scale (ABC))
  • Perceived self-efficacy for getting up from the floor, assessed via a direct question (scale from 0 to 10).
  • Level of physical activity, assessed using a validated self-administered questionnaire (International Physical Activity Questionnaire - Short Form, IPAQ-SF).
  • Number of falls and circumstances

The criteria assessed via questionnaire (balance confidence during daily activities, perceived self-efficacy for getting up from the floor, level of physical activity, number of falls) will also be assessed by telephone 12 weeks after the intervention (T2).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • People over the age of 65
  • Able to walk 100 m independently, with or without a walking aid (1 cane or 1 crutch)
  • Individuals who have fallen at least once in the past 12 months
  • Individuals who feel unsteady while standing or walking
  • Individuals who express a fear of falling
  • Individuals enrolled in the social security system or a similar program
  • Individuals who have been informed and have given their written consent to participate in the study

Exclusion criteria

  • Refusal to participate in the study
  • Individuals who walk with two canes or a walker, or who are unable to walk
  • Medical contraindications to physical activity (cardiac conditions, acute illness, uncompensated vestibular disorder).
  • Major cognitive impairment or dementia preventing active participation.
  • Individuals with other contraindications, at the investigator's discretion
  • Recent orthopedic surgery (<3 months).
  • Major uncompensated sensory impairment

Treatment and study plan

Balance Workshops

Other

Participants take part in the standard program, which includes one-hour group sessions designed to improve balance, mobility, coordination, muscle strength, confidence in moving around, and fall-prevention behaviors.

The sessions include:

  • static and dynamic balance exercises;
  • muscle-strengthening exercises;
  • coordination and dual-task exercises;
  • joint mobility exercises;
  • educational sessions on physical activity, the environment, nutrition, and fall prevention;
  • discussion and wrap-up sessions to identify simple actions participants can take between sessions.

"getting up from the floor" module

Other

This 20 minutes module includes a safe progression covering:

  • lower-body mobility, particularly the ankles, knees, and hips;
  • weight shifts;
  • gradual transitions to the floor;
  • exercises in intermediate positions: lunge, knight's stance, all fours;
  • strategies for turning and moving on the floor;
  • learning to transition from the floor to a standing position;
  • identifying secure points of support;
  • managing apprehension;
  • applying what has been learned to everyday situations. Progression is tailored to each participant's level. Moving to the floor is never required. In cases of apprehension, pain, functional limitations, or identified risks, the physical therapist suggests adaptations: exercises with support, use of a stable chair, partial exercises, movement simulation, or identifying possible steps without fully lowering oneself to the floor.

Primary outcomes

  1. Feasibility of the intervention

    Time frame: 6 months

    The feasibility of the intervention will be assessed based on the fidelity of its implementation: adherence to the content. This aspect will be evaluated by the research team using a standardized monitoring form completed by the physical therapists.

  2. Feasibility of the intervention

    Time frame: 6 months

    The feasibility of the intervention will be assessed based on the fidelity of its implementation: the pedagogical progression. This aspect will be evaluated by the research team using a standardized monitoring form completed by the physical therapists.

  3. Feasibility of the intervention

    Time frame: 6 months

    The feasibility of the intervention will be assessed based on the fidelity of its implementation: the duration of the scheduled sessions. This aspect will be evaluated by the research team using a standardized monitoring form completed by the physical therapists.

  4. Acceptability of the intervention

    Time frame: 6 months

    The acceptability of the intervention will be assessed based on the following factors:

    • Participants' satisfaction with the program, measured using a satisfaction questionnaire administered at the end of the intervention.

    The satisfaction survey for participants in the control group alternates between multiple-choice questions (to assess overall satisfaction, sense of safety, trust built, and organization) and open-ended questions (to gather their personal feedback on the benefits, challenges they faced, and areas for improvement).

    The satisfaction survey for participants in the intervention group alternates between multiple-choice questions (to assess overall satisfaction, organization, sense of safety, and confidence regarding falls) and open-ended questions (to gather personal impressions on benefits, challenges, and areas for improvement).

  5. Acceptability of the intervention

    Time frame: 6 months

    The acceptability of the intervention will be assessed based on the following factors:

    • Physical therapists' satisfaction with the program, measured using a satisfaction questionnaire administered at the end of the intervention.

    The questionnaire for physical therapists in the control group alternates between multiple-choice questions (to assess the module's usefulness, satisfaction, ease of use, and relevance) and open-ended questions (to gather feedback, identify difficulties observed, and collect suggested adaptations from the instructor).

    The questionnaire for physical therapists in the intervention group combines multiple-choice questions (to assess the time spent, progress, ease of implementation, and relevance of the module) and open-ended questions (to gather feedback on participants' reactions, challenges, adjustments made, and areas for improvement).

  6. Acceptability of the intervention

    Time frame: 6 months

    The acceptability of the intervention will be assessed based on the following factors:

    • Program adherence, assessed by the attendance rate (number of sessions attended relative to the total number of sessions offered) as well as the dropout rate during the program.

Secondary outcomes

  1. Ability to stand up from the floor

    Time frame: at the beginning of the program (T0) and at the end (T1)

    Ability to get up from the floor, assessed using a standardized floor-to-standing test, which allows for an evaluation of the level of assistance required (0: cannot get up, 1: with assistance, 2: without assistance) and the time required to get up.

    The floor-to-standing test will be used to assess the functional ability to get up after a fall. Participants will be asked to lie down on the floor in a standardized position and then get up as quickly as possible, without assistance, according to the instructions. The time taken to get up will be recorded, along with the strategy used (support, external aids). This test is considered a relevant indicator of impaired health, fall risk, and fall severity

  2. Functional mobility

    Time frame: at the beginning of the program (T0) and at the end (T1)

    Functional mobility, assessed using the Timed Up and Go (TUG) test. The Timed Up and Go test measures basic functional mobility, including the ability to stand up, walk, turn around, and sit back down. The total time in seconds will be recorded.

  3. Functional lower-limb strength

    Time frame: at the beginning of the program (T0) and at the end (T1)

    Functional strength of the lower limbs, assessed using the Five-Time Sit-to-Stand Test.

    The Five-Time Sit-to-Stand Test (FTSST) will be administered to assess lower-limb strength and functional mobility. Participants will be asked to stand up and sit down on a chair five times as quickly as possible, with their arms crossed over their chest. The total time required to complete the task will be recorded.

  4. Postural balance

    Time frame: at the beginning of the program (T0) and at the end (T1)

    Postural balance: Static balance will be assessed using the Romberg test, the tandem stance test, and the single-leg stance test.

    For the Romberg test, participants stand with their feet together and arms at their sides, maintaining the position for up to 20 seconds-first with their eyes open, then with their eyes closed, and finally with their eyes open and their head tilted back.

    For the tandem stance test, participants stand with one foot directly in front of the other, heel to toe, for up to 20 seconds. Performance will be recorded separately for the right-foot-forward and left-foot-forward positions For the single-leg balance test, participants must stand on one leg without support, with the non-weight-bearing foot positioned at calf height without touching the leg. The time spent maintaining balance, up to 20 seconds, will be recorded for each leg.

  5. Confidence in balance during daily activities

    Time frame: at the beginning of the program (T0) and at the end (T1)

    Confidence in balance during daily activities (Activities-specific Balance Confidence Scale, ABC) The Activities-specific Balance Confidence (ABC) Scale is used to assess participants' confidence in their ability to maintain balance during various activities of daily living. It consists of 16 items scored from 0% (no confidence) to 100% (complete confidence). The total score is the average of the item scores; a low score is associated with an increased risk of falls and activity limitations. The ABC scale is more sensitive to change than the Falls Efficacy Scale, making it more suitable for detecting a decline in balance confidence among older adults with higher levels of functioning.

  6. Perceived self-efficacy for getting up from the floor

    Time frame: at the beginning of the program (T0) and at the end (T1)

    Perceived self-efficacy for getting up from the floor, assessed using a direct question (scale from 0 to 10).

    "I am confident in my ability to get up from the floor while lying on my back, on my own." Based on the general self-efficacy scale and the confidence survey, we will ask patients to rate their level of confidence in their ability to get up from the floor using a numerical scale from 0 to 10 (0 = I am not confident and 10 = I am very confident).

  7. Level of physical activity

    Time frame: at the beginning of the program (T0) and at the end (T1)

    Perceived self-efficacy for getting up from the floor, assessed using a direct question (scale from 0 to 10).

    "I am confident in my ability to get up from the floor while lying on my back, on my own." Based on the general self-efficacy scale and the confidence survey, we will ask patients to rate their level of confidence in their ability to get up from the floor using a numerical scale from 0 to 10 (0 = I am not confident and 10 = I am very confident).

  8. Number of falls

    Time frame: at the beginning of the program (T0) and at the end (T1)

    Number of falls (over the past 3 months) and circumstances. The number of falls will also be assessed 3 months after the 12-week mark following the intervention (T2) via a telephone interview.

Study contacts

Contact information is provided by the study sponsor or research team.

Christine BIGEARD

CONTACT

[email protected]

00 33 4 78 24 09 00

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Emile Roux

Other

Registry information

Official study title

Balance Workshops Focusing on Learning to Stand Up From the Floor for Older Adults Living at Home: A Pilot Study - Sol'Up

Important dates

Study start
2026
Primary completion
2028
Study completion
2029
First posted
Aug 3, 2026
Registry last updated
Aug 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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