Effect of interval exercises on sleep in older adults

• Register: CTRI
• Last refreshed on: 24 November 2021
• Main ID: CTRI/2016/07/007102
• Date of registration: 18-07-2016
• Prospective Registration: Yes
• Primary sponsor: Pravara Institute of Medical Sciences
• Public title: Effect of interval exercises on sleep in older adults
• Scientific title: Effect of interval training on sleep quality in geriatric individuals
• Date of first enrolment: 04-07-2017
• Target sample size: 63
• Recruitment status: Completed
• URL: http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=12588
• Study type: Interventional
• Study design: Randomized, Parallel Group, Active Controlled Trial; Method of generating randomization sequence:Permuted block randomization, fixed Method of allocation concealment:Sequentially numbered, sealed, opaque envelopes Blinding and masking:Participant Blinded
• Phase: N/A

Countries of recruitment

Greece, India

Contacts

• Name: Aashirwad Mahajan
• Affiliation: Pravara Institute of Medical Sciences, Maharashtra, India.

• Name: Dr Subhash Khatri
• Affiliation: Pravara Institute of Medical Sciences, Maharashtra, India.

Key inclusion & exclusion criteria

Inclusion criteria: Complaining of difficulty initiating or maintaining sleep

Scoring greater than 5 on Pittsburgh Sleep Quality Index

Screened by physician for participation in physical activity


Exclusion criteria: Participants with impaired cognitive function.

Patients with uncontrolled hypertension.

Patients having unstable angina

Participants with severe cardiovascular abnormality.

Participants with severe Respiratory disorders.

Participants with severe musculoskeletal disorders.

Participants with neurological disorders

Participants with psychiatric disorders

average alcohol intake greater than 3 drinks per day

and nonsmoker

caffeine consumption greater than

300 mg per day.



Age minimum:
Age maximum:
Gender:

Intervention(s)

Intervention1: Interval training: Exercise intervention given on bicycle ergometer with heart rate monitoring for 8 weeks.
Frequency 3 times in a week, 1 session per day total duration 8 weeks.Intensity given at 65 percent of maximum heart rate for 3 minutes and 85 percent of maximum heart rate for 1 minute. Maximum heart rate calculated by Inbar method. Total 8 repeated bouts of consecutive 4 minutes of cycling.
Duration of 1 interval training session is 30 to 35 minutes preceded and followed by warm up and cool down session of approximately 5 to 10 minutes each. So total duration of 1 session is approximately 40 to 50 minutes.
Control Intervention1: sleep hygiene techniques: techniques to improve sleep hygiene given in the form of a handout and monitored accordingly. These instructions for sleep hygiene followed by participant for 8 weeks daily. Followup for the same taken every other day and with the help of sleep diary to be filled by the participant

Primary Outcome(s)

1. Pittsburgh Sleep quality Index for measuring sleep quality

3. Polysomnography sleep variables: Total sleep time, Sleep onset latency, Sleep efficiency, Wake after sleep onset, Percentages of Stage 1 and Stage 2 sleep, Slow wave sleep, REM sleep percentage,Timepoint: Before and after 8 weeks of intervention

Secondary Outcome(s)

Short form 12 questionnaire for Quality of life

Timepoint: Before and after 8 weeks of intervention

Secondary ID(s)

NIL

Source(s) of Monetary Support

Euphrates Erasmus Mundus scholarship programme Lot 2 Action 13 by European Union

Secondary Sponsor(s)

Technological Educational Institute of Western Greece

Ethics review

Status: Approved
Approval date: 07/11/2014
Contact:

Institutional Ethical Committee, PIMS-DU

Results

• Date Completed: 26/02/2019