CTRI Number	CTRI/2016/05/006937 [Registered on: 16/05/2016] Trial Registered Retrospectively
Last Modified On:	16/05/2016
Post Graduate Thesis	No
Type of Trial	Interventional
Type of Study	Physiotherapy (Not Including YOGA) Nutraceutical
Study Design	Randomized, Parallel Group, Multiple Arm Trial
Public Title of Study Modification(s)	Effect of nutritional supplementation and nordic walking on the friality status compared to the baseline status.
Scientific Title of Study	A multimodal intervention (Nordic walking training and Nutritional supplementation) in Pre-frail older Indians: A Randomized Control Trial
Secondary IDs if Any	Secondary ID  Registry  NIL  NIL
Details of Principal Investigator or overall Trial Coordinator (multi-center study)	Name  Prashun Chatterjee  Address  3095 A , Department of Geriatric Medicine, 3 rd floor, Teaching block, AIIMS South DELHI 110029 India  Phone     Fax     Email  drprasun.geriatrics@gmail.com
Details Contact Person Scientific Query	Name  Prashun Chatterjee  Address  3095 A , Department of Geriatric Medicine, 3 rd floor, Teaching block, AIIMS DELHI 110029 India  Phone     Fax     Email  drprasun.geriatrics@gmail.com
Details Contact Person Public Query	Name  Prashun Chatterjee  Address  3095 A , Department of Geriatric Medicine, 3 rd floor, Teaching block, AIIMS DELHI 110029 India  Phone     Fax     Email  drprasun.geriatrics@gmail.com
Source of Monetary or Material Support	National Program for Health Care of Elderly MOHFW
Primary Sponsor	Name  National Program for Health Care of The Elderly MOHFW  Address  3095 A, Department of Geriatric Medicine,3rd floor, Teaching Block, AIIMS  Type of Sponsor  Government funding agency
Details of Secondary Sponsor	Name  Address  NIL  NIL
Countries of Recruitment	India
Sites of Study	No of Sites = 1   Contact Person  Name of Site  Site Address  Phone/Fax/Email  Dr A B Dey  AIIMS Department of Geriatric Medicine  3095 A, Department of Geriatric Medicine, 3 rd Floor, Teaching Block, AIIMS-110029 South   9868397241 abdey@hotmail.com
Details of Ethics Committee	No of Ethics Committees= 1   Name of Committee  Approval Status  AIIMS Ethics Committee  Approved
Regulatory Clearance Status from DCGI	Status  Not Applicable
Health Condition / Problems Studied	Health Type  Condition  Patients  Pre-Frial by Frieds Criteria
Intervention / Comparator Agent	Type  Name  Details  Intervention  Group A - Nordic walking training with nutritional counselling  Occupational therapist were educated and qualified as Nordic walking instructor. The subjects were trained for 12 weeks, with a frequency of three times per week. Each session lasted 60 minutes and consisted of warming up, practicing Nordic walking competence, improving intensity and distance of Nordic walking and finally a cooling down. The pole length used for the Nordic walk was selected and adjusted according to the subjects physique to permit a smooth arm motion, based on the International Nordic Walking Federation (INWA) formula (0.68Xbody height cm).14 The training took place inside the hospital at day care center of department of Geriatric Medicine. During this training period, subjects did not participate in any other training programs or physical therapy treatment. Assessment of post intervention dependent variables occurred within 1 week of the final walking session  Comparator Agent  N/A  Subjects in group A/ B/C were compared Pre and Post intervention. No placebo group was in the study.
Inclusion Criteria	Age From  65.00 Year(s) Age To  85.00 Year(s) Gender  Both  Details  Patients key inclusion criteria Parameters Scale Acute illness, Severe obstructive airway disease FEV1 < 30% Severe Systolic Dysfunction EF< 30% Severe painful upper limb and lower limb conditions, severe dementia MINICOG score 0 Severe Depression GDS >11
ExclusionCriteria	Details  any Person with a score <1 or >2 on Fried Friality Criteria not have nutritional supplementation in the previous 6 months
Method of Generating Random Sequence	Computer generated randomization
Method of Concealment	On-site computer system
Blinding/Masking	Open Label
Primary Outcome Modification(s)	Outcome  TimePoints  to determine whether delivering a multi-factorial, interdisciplinary intervention in pre-frail older people could prevent or revert the progression to frailty along with conferring improved mobility   6weeks and 12 weeks following intervention in all the three arms.
Secondary Outcome	Outcome  TimePoints  cognitive outcome of the intervention in different groups  3 months
Target Sample Size	Total Sample Size="66" Sample Size from India="66"
Phase of Trial	N/A
Date of First Enrollment (India)	01/12/2012
Date of First Enrollment (Global)	No Date Specified
Estimated Duration of Trial	Years="2" Months="0" Days="0"
Recruitment Status of Trial (Global)	Not Applicable
Recruitment Status of Trial (India)	Completed
Publication Details	N/A
Brief Summary	Nordic Walking (NW) is a form of walking, performed using polesintended to be swung forward and backward with the upper body, which may improve upper body muscle strengthand exercise the lower body and gait speed, while placing less force on knee. NW can improve endurance, muscle strength and flexibility, functioning body balance system. Nutritional deficiency especially protein and aminoacids, is one of the major component of development of sarcopenia and fraility. Noticeable improvement in muscle strength after supplementation of protein and micro-nutrients has been observed. In  this study ,we proposed to intervene in pre-frail elderly (by Fried Score) with need based individualized nutritional support and nordic walking training and see the response in the domain of mobility and nutritional status.