Assessment: Is This Publishable?

What You Have

• No data has been collected yet
• No results, analysis, or findings exist
• This is a pre-study document, not a completed study

To Make It Publishable, You Have Two Paths

• Well-defined background and rationale
• Clear intervention (dual-circuit structure is original enough)
• Good outcome measure selection (HHD, FIST, MoCA, Stroop)
• Vancouver-style references included

• The intervention duration is inconsistent — the IEC letter says 4-month project, participant sheet says 2 weeks of training, and the procedure mentions 6 months. You must standardize this.
• No control group is described — labelled "randomized pilot trial" but there's no randomization arms or comparator group defined.
• Reference 12 (Stead M, Paul E.) is incomplete — no journal, volume, or pages.
• Reference 14 (Gates NJ) has a note "exact review ID should be confirmed" — this must be resolved before publication.
• The "Cool up" heading in Circuit 2 should be "Cool down" (typographical error).
• The primary objective lists MoCA and Stroop under "chair-based exercises" but these measure cognition from both exercise + cognitive training — the objective wording is imprecise.

• Journal of Geriatric Physical Therapy
• Physiotherapy Research International
• Disability and Rehabilitation
• Archives of Gerontology and Geriatrics

Overall Quality of the Proposal Itself

Drawbacks of This IEC Proposal

1. METHODOLOGY — Major Issues

• The study is called a "randomized pilot trial" but there is no mention of a comparator arm. Who are participants being randomized to? Without a control group, the word "randomized" is misleading and scientifically indefensible.
• An IEC reviewer will ask: randomized how? Block randomization? Simple? Stratified?

• IEC letter and proposal say 4 months total study duration
• Participant information sheet says 2 weeks of training
• Kannada version says 6 months
• These three documents cannot contradict each other in an ethics submission

• The intervention record form has blank fields for "sessions/week" and "total weeks" — these are left unfilled in the proposal itself. An IEC expects the full protocol to be pre-specified, not left for later.

• The title says "short term" but nowhere in the proposal is this duration operationally defined. Is it 2 weeks? 4 weeks? This is a fundamental gap.

2. STUDY DESIGN — Significant Gaps

• G*Power calculation uses a generic moderate effect size (d = 0.5) with no citation or prior study justifying that effect size for this specific intervention in this specific population.
• The effect size should be drawn from a pilot or comparable study in the literature.

• How will participants be allocated? No mention of sequencing, concealment, or allocation method. CONSORT guidelines require this.

• For a randomized trial, assessor blinding should at minimum be addressed. It is absent.

• There is no post-intervention follow-up assessment. Only pre and post are measured. This prevents any understanding of whether effects persist.

3. OUTCOME MEASURES — Problems

• Reference 29 (Gorman et al., 2010) is a stroke population study. Using FIST in healthy community-dwelling older adults requires justification of applicability. An IEC reviewer may question this.

• It is listed under screening criteria to classify activity level, yet also appears in the outcome measures list. You cannot use the same instrument for both eligibility screening and as an outcome variable — this is a methodological conflict.

• The procedure says "sitting or prone position" for plantar flexors. Prone position contradicts the chair-based nature of the entire study. This inconsistency could be flagged.

• For HHD, FIST, MoCA, and Stroop, no MCIDs are referenced. This is important for interpreting whether changes are clinically meaningful.

4. REFERENCES — Errors That Will Be Flagged

5. ETHICAL DOCUMENTATION — Gaps

• The risks section lists muscle soreness and fatigue but there is no protocol for what happens if a participant experiences a fall, cardiac event, or injury during the session. IEC committees routinely require this.

• This is concerning. Even low-intensity exercise with older adults (60–75 years) carries risk. Listing no emergency plan is ethically inadequate. At minimum, first-aid availability and referral pathway should be stated.

• The main proposal (Section 8f) lists neurological conditions, musculoskeletal conditions, psychiatric conditions, visual/hearing impairments as exclusions.
• The proforma screening checklist only has 4 exclusion tick boxes: severe cognitive impairment, unstable cardiac condition, severe musculoskeletal disorder, neurological condition.
• "Severe" is added in the proforma but not in the proposal — these must match exactly.

• For a pilot randomized trial, even a basic statement about stopping rules or interim monitoring is expected.

6. ADMINISTRATIVE / FORMATTING ISSUES

• Declaration of Originality does not include the study title — it says "the study titled" and then leaves it blank.
• Contribution table for Ms. Sandhya M (second co-investigator) lists the same generic text as Dr. Anjali Suresh — no differentiation in roles.
• "Cool up" is written instead of "Cool down" in Circuit 2 — a proofreading error that undermines the document's professionalism.
• "Primay investigator" is misspelled on the cover letter.
• The Proforma has "Shoulder bductors" (missing letter 'a') in Section H post-intervention.
• The IPAQ form included is the long form (12 questions including job-related activity), not the short form (IPAQ-SF) that the proposal describes using — these are different validated instruments.

7. STATISTICAL PLAN — Insufficient

• States "parametric, non-parametric and correlation analysis will be done after checking normality" but does not specify:
  • Which test for normality (Shapiro-Wilk is preferred for n=30)
  • Which specific parametric test (paired t-test? ANOVA?)
  • Which specific non-parametric test (Wilcoxon? Mann-Whitney?)
  • What correlation is being examined and between which variables
• SPSS version 25 is specified — acceptable, but the analysis plan must be pre-specified, not post-hoc.

Summary Priority List for Revision

Is This Study Feasible?

The Core Idea — YES, It's Very Doable

• Low-cost (no expensive equipment except HHD)
• Low-risk for participants
• Practically executable in a community hall, temple, or senior center
• Well-supported by existing literature (your own references confirm this)

Issue-by-Issue Feasibility

🟢 Easy to Fix (Before Resubmission)

🟠 Moderate Effort (Needs Thinking, But Doable)

• Decide: Is the intervention 2 weeks or 4 weeks?
• For a UG BPT project with 4-month total timeline, 4 weeks of intervention is realistic
• Then update all three documents (proposal, PIS, Kannada version) to say the same thing
• Time needed: 1 day

• Simply state in the methodology: "Short term is defined as a [4]-week intervention period"
• One sentence addition

• Normality: Shapiro-Wilk (n=30 is small)
• If normal: Paired t-test (pre vs post, within group)
• If not normal: Wilcoxon signed-rank test
• This is standard for a pre-post pilot study
• Time needed: 1–2 hours with supervisor guidance

• Use IPAQ-SF only for screening (to confirm low-to-moderate activity level at baseline)
• Remove it from the outcome measures list
• Your actual outcomes are HHD, FIST, MoCA, Stroop — that's sufficient
• Time needed: 1 hour to revise the document

• Add one short paragraph: "In the event of any adverse event (fall, chest pain, dizziness), the session will be stopped immediately. First aid will be available on site. Participant will be referred to the nearest medical facility. The event will be reported to the CEC within 24 hours."
• Time needed: 30 minutes

🔴 Requires More Work (But Still Achievable for a UG Project)

• Recruit 30 participants, randomize into:
  • Group 1 (n=15): Chair exercise + cognitive training
  • Group 2 (n=15): Chair exercise only (active control)
• This makes it a genuine pilot RCT
• Add one paragraph describing randomization (e.g., sealed envelope method)
• Pros: Scientifically stronger, publishable
• Cons: Needs 30 participants across two groups, slightly more complex

• Remove the word "randomized"
• Call it: "Single-group experimental pre-test post-test pilot study"
• Much simpler, honest, and still publishable as a pilot
• Pros: Easier to execute, suitable for UG project, no randomization needed
• Cons: Lower evidence level, but acceptable for a BPT project

Recommendation for a BPT 7th semester student: Choose Option B. It is honest, feasible within 4 months, and still publishable in a physiotherapy journal.

• For Option B (single group pre-post), cite a similar study showing effect on MoCA or HHD in older adults with exercise
• Example: Liao et al. (your reference 5) showed improvements in cognitive function with chair-based exercise
• Ask your supervisor to help extract the effect size from that paper and re-run G*Power
• Time needed: 2–3 hours with supervisor

• Add one sentence acknowledging FIST was originally validated in stroke but has since been used in healthy aging populations
• Alternatively, replace with Functional Reach Test or Timed Up and Go — both are well-validated in community-dwelling elderly
• However, since your intervention is chair-based, FIST actually makes sense contextually — just add a citation supporting its use in non-stroke populations

Realistic Timeline to Resubmit

Bottom Line

If Mistakes Are Not Rectified — What Happens?

At the IEC Level

• Most institutional ethics committees, especially for UG student projects, do not outright reject on first submission
• They will return it with a list of queries/corrections
• You will get a chance to respond — this is normal and expected
• SDUAHER's CEC likely follows this standard process

If You Proceed Without IEC Clearance

• Any data collected without ethical clearance is invalid
• It cannot be submitted, published, or used in your project report
• This is non-negotiable under ICMR guidelines and institutional rules

• BPT final year projects at SDUAHER require proof of ethical clearance
• Without it, the examiner board can reject the dissertation
• This directly affects your degree completion

• Any journal will ask for the ethics certificate
• Submission without it leads to desk rejection
• If discovered after publication, the paper gets retracted

If You Submit As-Is and Get Queries Back

1. CEC reviews and sends back a query letter with specific corrections required
2. You have 1–3 months to respond (depending on SDUAHER's timeline)
3. You submit a point-by-point response
4. CEC approves with or without further queries

• If CEC queries take 2 months to resolve, your 4-month project window shrinks to 2 months for actual data collection
• With only 30 participants needed, 2 months is still doable — but tight
• If the timeline pushes past your dissertation submission deadline, you may need to request an extension

Worst Case Scenario (If Nothing Is Fixed and Time Runs Out)

What You Should Actually Do Right Now

• Fix the duration: Pick one number (recommend 4 weeks intervention) and change it in all documents
• Fix typos: Primay → Primary, Cool up → Cool down, bductors → abductors
• Fill in the blank study title in the Declaration of Originality

• Add the adverse event paragraph (the one sentence plan described earlier)
• Fix references 12 and 14 on PubMed
• Remove "randomized" OR add a two-line randomization method

• Ask Dr. Anjali Suresh to review the revised version
• Her signature as co-investigator means she is also responsible — she will want these fixed

The Honest Reality for a BPT Student

The IEC at a university like SDUAHER is familiar with UG student proposals. They will almost certainly return it with queries rather than reject it outright. You are not in serious danger if you act quickly.