Evidence map›Paper›PMID 34531216›Full record

ArticleBMJ open2021

Study protocol for yoga-based lifestyle intervention for healthy ageing phenotype in the older adults (yHAP): a two-armed, waitlist randomised controlled trial with multiple primary outcomes.

Vijaya Majumdar, Atmakur Snigdha, N K Manjunath, Raghuram Nagarathna, Ramesh Mavathur, Amit Singh, Kalpana S R, Nagendra H R

Abstract readClinical Trial Protocol
In one paragraph

Article in BMJ open, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Trial
  2. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors.

Vijaya MajumdarSwami Vivekananda Yoga Anusandhana Samsthana, Bengaluru, Karnataka, India majumdar.vijaya@gmail.com.ORCID 0000-0002-8594-5761
Atmakur SnigdhaSwami Vivekananda Yoga Anusandhana Samsthana, Bengaluru, Karnataka, India.ORCID 0000-0001-9949-970X
N K ManjunathSwami Vivekananda Yoga Anusandhana Samsthana, Bengaluru, Karnataka, India.
Raghuram NagarathnaSwami Vivekananda Yoga Anusandhana Samsthana, Bengaluru, Karnataka, India.
Ramesh MavathurSwami Vivekananda Yoga Anusandhana Samsthana, Bengaluru, Karnataka, India.
Amit SinghSwami Vivekananda Yoga Anusandhana Samsthana, Bengaluru, Karnataka, India.
Kalpana S RSri Jayadeva Institute of Cardiovascular Sciences and Research, Bangalore, Karnataka, India.
Nagendra H RSwami Vivekananda Yoga Anusandhana Samsthana, Bengaluru, Karnataka, India.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionThe conceptualisation of healthy ageing phenotype (HAP) and the availability of a tentative panel for HAP biomarkers raise the need to test the efficacy of potential interventions to promote health in older adults. This study protocol reports the methodology for a 24-week programme to explore the holistic influence of the yoga-based intervention on the (bio)markers of HAP. METHODS AND ANALYSIS: The study is a two-armed, randomised waitlist controlled trial with blinded outcome assessors and multiple primary outcomes. We aim to recruit 250 subjects, aged 60-80 years from the residential communities and old age clubs in Bangalore city, India, who will undergo randomisation into intervention or control arms (1:1). The intervention will include a yoga-based programme tailored for the older adults, 1 hour per day for 6 days a week, spread for 24 weeks. Data would be collected at the baseline and post-intervention, the 24th week. The multiple primary outcomes of the study are the (bio)markers of HAP: glycated haemoglobin, low-density lipoprotein cholesterol (LDL-C), systolic blood pressure, and forced expiratory volume in 1 s for physiological and metabolic health; Digit Symbol Substitution Test, Trail Making Tests A and B for cognition; hand grip strength and gait speed for physical capability; loneliness for social well-being and WHO Quality of Life Instrument-Short Form for quality of life. The secondary outcomes include inflammatory markers, tumour necrosis factor-alpha receptor II, C reactive protein, interleukin 6 and serum Klotho levels. Analyses will be by intention-to-treat and the holistic impact of yoga on HAP will be assessed using global statistical test. ETHICS AND DISSEMINATION: The study is approved by the Institutional Ethics Committee of Swami Vivekananda Yoga Anusandhana Samsthana University, Bangalore (ID: RES/IEC-SVYASA/143/2019). Written informed consent will be obtained from each participant prior to inclusion. Results will be available through research articles and conferences. TRIAL REGISTRATION NUMBER: CTRI/2021/02/031373.

Indexed as

Healthy AgingYogaAgedAged, 80 and overHand StrengthHealth PromotionHumansIndiaMiddle AgedPhenotypeQuality of LifeRandomized Controlled Trials as Topicclinical trialscomplementary medicinegeriatric medicinepublic health

Identifiers

PMID34531216
PMCPMC8449966

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.