Yoga therapy on elderly patients with fear of fall: an open-label randomised controlled trial (YOFEAR trial)

Inclusion criteria

• Patients of age 60 years and above.

• Patients with moderate to high concerns of FoF as per FES-I scale.

• Patients with Activities of Daily living score of 6 as per Katz ADL scale.

Exclusion criteria

• Patients with ulcers, gangrene, burns over the foot.

• Patients with musculoskeletal deformities.

• Patients with cognitive impairment with Hindi Mental State Examination (HMSE) score <19.

• Patients with known psychiatric disorders and who are under current treatment for the same conditions (antidepressants, antipsychotics) for more than 3 months.

• Patients with moderate to severe hearing impairment.

• Patients with visual acuity less than 6/60 with correction.

Study sample size

The sample size was calculated using G power software, with effect size 0.8; alpha error was kept at 0.05; power of 0.80; allocation ratio 1:1. The sample size was calculated as 52 with 26 subjects on each arm. Effect size was kept at 0.8 to get a large effect size since according to the values, putting in the formula gives a total sample size of 52. For the study purpose, we kept the attrition rate at 20% according to which the total sample size was 62 with 31 participants on each arm.

Study recruitment

Patient visiting OPD will be screened for eligibility criteria and will be recruited in the study after obtaining written informed consent. Probability sampling will be done by using simple random sampling method. The enrolment of the study will start from 24 May 2023 and the proposed last date of the study is 24 August 2023.

Randomisation

Computer-generated random allocation sequence will be generated using randomisation.com. Block randomisation with block size 4 will be done by one of the Co-PI, YB.21 Sequentially numbered opaque scaled envelopes will be done for allocation concealment. Enrolment of patient and assigning the participants to the intervention will be done by MP.

As depicted in table 1, participants in arm ‘A’ will be receiving a 12-week yoga therapy as an add-on intervention to the standard therapy of their primary disease as per the respective guidelines.

Choice of comparators

The control group will consist of participants with a fear of falling who will receive treatment in accordance with the prevailing standard of care therapy for their underlying conditions, following the established guidelines specific to each condition.

Intervention modification

Any participant receiving the trial intervention who experiences hospitalisation or death for any reason will be withdrawn from the trial. A comprehensive analysis of the event will be conducted for each discontinued case at the conclusion of the study.

Intervention adherence

Participants will be followed up on a weekly basis during the intervention period of 3 months by phone contact/zoom meeting (based on the feasibility) to ensure proper adherence to the intervention. Caregivers of participants or participants well equipped with technical knowledge will be asked to send a recorded video of participant’s yoga sessions at home on a daily basis to the instructor.

Endpoints

Data collection

Data collection using Performa after written informed consent; evaluation for all the patients will be as follows:

• Katz ADL.

• FES I.

• BBS HMSE.

• Short Form (SF) 12 (SF-12) for quality of life—A performed proforma (online supplemental table S2) will be used to collect the patient demographic data and scores of various scales to be used along with a detailed consent form explaining the study aims, objectives, methodology, conflicts and benefits of the particular intervention.

• All patients will undergo baseline laboratory investigations, which will include complete blood count, kidney function test, liver function test, glycosylated haemoglobin; thyroid-stimulating hormone, triiodothyronine, ECG, FES-I, BBS, SF-12 and same will be repeated at 12 weeks except chest X-ray, echocardiography and ECG.

• Cognitive status assessment: The MMSE (Mini Mental State Examination) is a globally used instrument for cognitive screening, which nevertheless has a bias with respect to education and language. The Indo-U.S. Cross-National Epidemiology Study developed a modified version of MMSE, the HMSE, to counter this bias in India among rural and illiterate elderly. The cut-off score for possible cognitive impairment in HMSE is 19 or below. It is an excellent tool to assess cognitive ability; it encompasses the assessment of various dimensions that reflect the cognitive abilities of a person apart from being easily understood by most of the local population.

• Assessment of FoF: FES-I is a 16-item questionnaire, either self-administered or administered through interview, which asks the respondents to rate their level of confidence in performing daily life activities, rating each item on a 4-point scale with one indicating ‘extreme confidence’ and four indicating ‘no confidence at all’. The FES-I assesses ‘concern’ about falling, closely related to fear and also socially acceptable by older adults. It has been developed to modify a previously existing scale FES, to maximise its suitability of usage in different languages and cultural contexts and to make it more approachable for translation. Studies have shown that FES-I is likely to perform better than FES in detecting concerns related to balance or fall.22 A study done by Kempen et al has shown that the FES-I has good internal and test–retest reliability in community-dwelling older people.23

• Balance assessment: BBS was developed in 1989 to provide clinicians with a standardised measurement tool to assess balance in the elderly individuals. The BBS is a 14-item scale that challenges individuals balance in a variety of functional positions, ranging from sitting to standing and static and dynamic.24 It is a 14-item list with each item consisting of 5-point ordinal scale ranging from 0 to 4, with 0 indicating the lowest level of function and four the highest. A score of 56 generally indicates functional balance while a score less than 45, indicates they may be at a greater risk of falling. Studies of various elderly populations have shown high intrarater and inter-rater reliability. Content and criterion-related validity has been supported by moderate to high correlations between BBS scores and other functional measurements in older adults with functional disability.24

• Assessment of quality of life: The SF-12 is a self-reported outcome measure assessing the impact of health on everyday life, often used as a tool for quality-of-life measurement. It is a shortened version of SF-36, producing similar results for physical and mental health scores with far less respondent burden.25 It uses the same eight domains as SF-36 to assess the physical and mental health of the individual. It summarises two components, namely Mental Component Score-12 and Physical Component Score-12. Studies have shown that when compared with SF-36, in various patient groups, the score in SF-12 recorded the same level of health and change over time. Although it is not available for free due to a scoring programme, it can be used in research by a specific online calculator (https://orthotoolkit.com).

• Functional status assessment: ADL will be assessed by Katz ADL, a scale widely used that assesses six primary and psychological functions: bathing, dressing, going to the toilet, transferring, feeding and continence. It was originally designed to monitor the prognosis and treatment in chronically ill elderly patients, now being used to evaluate functional ability in older adults in various settings.26 It scores each of the activities in 0 or 1, 1 meaning they are independent and 0 meaning they need assistance or supervision in performing the task.

We will then randomise the participants into equal groups of cases and control each comprising 30 participants. The case group will be then subjected for a 12-week yoga intervention programme by a trained personal and then assessed after 3 months to evaluate the effect of yoga therapy on their complaints by analysing the data collected and compared with the control group for the same.

Data sharing statement

The information gathered throughout the trial will be securely stored in an encrypted computer system, with exclusive access granted to the authors involved in this study. As our institute lacks a dedicated data and security management board and considering the purely academic nature of the study, without any involvement of external industry conflicts, the authors will personally oversee the adherence to top-tier protocols for data quality. This oversight encompasses data collection, secure storage and meticulous analysis. Furthermore, a comprehensive registry will be maintained, documenting individual information of cases that might have discontinued therapy due to reasons such as loss to follow-up, hospitalisation or unfortunate demise.

Patient and public involvement

Individuals identified with a fear of falling during our departmental screenings will receive detailed information about the study’s design, intervention and expected outcomes. Prior to their participation in the study, written informed consent will be obtained from them.

Statistical analysis

The data will be extracted, followed by tabulation in an Excel sheet. All the analyses will be done with the help of R software. Based on the nature and distribution of variables, appropriate tests of significance will be applied. Changes in FES-I and BBS of two groups will be compared either by Student’s t-test for parametric data or Mann-Whitney U test for non-parametric data. The statistical significance will be defined as p<0.05 and taking confidence level as 95%. Data will be analysed as per-protocol and intention-to-treat method. Also, age-adjusted and sex-adjusted analyses will be performed using linear multiple regression.

Confidentiality of data and data access

The principal investigator will ensure the confidentiality of source data and documents. Patient information will be strictly confidential and used solely for the purpose of this study. Patient identities will be safeguarded at all times. In the event of a study-related inspection, the institutional ethics committee (IEC) will be granted access to the data, subject to approval from the authors and explicit mention of the inspection in the final publication draft.

Dissemination policy

The findings and interpretations, encompassing a thorough exploration of strengths, weaknesses, limitations, adverse incidents and avenues for future research, will be openly accessible to both scholars and the general public through publication in a research journal. The aim is to ensure unrestricted access to this publication, maximising its utility for broader societal advantages and future investigations.21

Ethical clearance

This study has received clearance from the institutional ethics committee (IEC) through letter no AIIMS/IEC/22/195, dated 22 April 2022. The research involving human participants has been approved by the IEC of All India Institute of Medical Sciences, Rishikesh (EC/NEW/Inst/2020/1046CDSCO, ECR/736/Inst/UK/2015/RR-21). It adheres to the ethical principles outlined in the Declaration of Helsinki, 1964 (updated 2013), and International Conference on Harmonisation-Good Clinical Practice. Online supplemental material containing study data will be provided, and individual patient data can be accessed on request through correspondence with the authors. Participants will be screened only after providing informed consent. Any protocol amendments will be communicated to the ethics committee. The trial is registered under the number CTRI/2022/06/043287, institutional ethics committee approval letter number is AIIMS/IEC/22/195, dated 22 April 2022. KK will obtain a written informed consent from each study participant (online supplemental table S3). Patient information sheet (Annexure-VI/VII) will be used to provide information about the study and study procedure in the local language. For illiterate study participants, consent will be read to the patient in his/her language to their satisfaction in the presence of an impartial witness. Modifications and deviations in the study protocol will be intimated to the institutional ethics committee registered under DHR (EC/NEW/Inst/2020/1046) and CDSCO (ECR/736/Inst/UK/2015/RR-21).

Patient safety

Any adverse events identified throughout the study will be promptly reported to the IEC. If a participant sustains an injury during the study, they will receive free medical treatment for as long as necessary or until it is determined that the injury is unrelated to the study intervention, whichever comes first. In the event of an emergency during a home yoga session, participants will be instructed to seek further care or treatment at the hospital’s emergency services.

Competing interest

All investigators declare no conflict of interest. The study will have no involvement with any organisation or entity with any financial interest. This is not industry sponsored. This study will not use any sponsored professional writers. The results will not be scrutinised by any external source before publication.